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Noted This Week - Archive 2021

Noted This Week - 2021 Archive

Archive of cancer-related news briefs, by week, for 2021

July 2021

July 9–15

  • The FDA upgraded enfortumab vedotin-ejfv’s (Padcev; Astellas/Seattle Genetics) accelerated approval to a full approval for patients with locally advanced or metastatic urothelial cancer who have already received a PD-1–PD-L1 therapy and a platinum-containing chemotherapy. The agency also expanded the indication to include patients with locally advanced or metastatic disease who have received at least one prior therapy and aren’t eligible for chemotherapy. The decision was based on positive results in the EV-301 and EV-201 trials. Enfortumab vedotin-ejfv is a Nectin-4–directed antibody–drug conjugate.
  • The agency also approved daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen) plus pomalidomide and dexamethasone for patients with multiple myeloma who have already received at least one therapy. The approval is based on the phase III APOLLO trial, in which patients treated with the investigational combination had a median progression-free survival of 12.4 months, compared with 6.9 months for those who received only pomalidomide and dexamethasone. Daratumumab and hyaluronidase-fihj is a subcutaneous form of the intravenous monoclonal antibody daratumumab.
  • The U.S. House of Representatives Subcommittee on Labor, Health and Human Services, and Education marked up its appropriations bill for the 2022 fiscal year. The bill proposes $49 billion in funding for the NIH, an increase of $6.5 billion. This includes an increase of $3.5 billion in NIH base funding, as well as $3 billion to establish the Advanced Research Projects Agency for Health. The funding would boost the NCI budget by $432 million to $7 billion, which would include $194 million for the Cancer Moonshot.
  • Communication of overall survival (OS) data varies considerably on cancer drug labels (JAMA Intern Med 2021 Jul 12 [Epub ahead of print]). Researchers analyzed labels for 50 drug indications approved between 2014 and 2018—23 of which reported OS based on interim analyses and 27 of which reported final OS. Twenty of the 23 labels stated that the drug did not have a significant OS benefit in interim analyses or that OS data were not yet mature; 12 of the 27 labels did not report the statistical significance of OS findings.
  • MRI may be a useful tool for guiding prostate biopsies in men with high PSA levels (N Engl J Med 2021 Jul 9 [Epub ahead of print]). In a trial of 1,532 men with a PSA of at least 3 ng/mL, 929 had an MRI followed by a biopsy if indicated, and 603 had a biopsy without imaging. In total, 21% of men in the MRI group were diagnosed with clinically significant cancer and 4% were diagnosed with clinically insignificant cancer, compared with 18% and 12%, respectively, in the nonimaging biopsy group.

Earlier This Year:

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Noted This Week Archive:

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  • Globally, 4.1% of new cancer cases in 2020 could be attributed to alcohol consumption (Lancet Oncol 2021 Jul 13 [Epub ahead of print]). Researchers combined estimates of alcohol intake per person per country in 2010 with data on new cancer cases in 2020. They found that 568,700 men and 172,600 women were diagnosed with alcohol-associated cancers—most commonly esophagus, liver, or breast cancer. Risky and heavy drinking were linked to the largest proportion of alcohol-related cancer cases: 39% and 47%, respectively.
  • The FDA lifted a partial clinical hold on a phase Ib trial testing the CDK8/CDK19 inhibitor RVU120 (SEL120; Ryvu Therapeutics) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. The hold was placed while the agency investigated a patient death. The company will modify its protocol to increase safety, taking steps such as tightening exclusion criteria and increasing patient monitoring.
  • Johnson & Johnson recalled five aerosol sunscreens after finding that they contained trace amounts of benzene. The carcinogen, which is not an ingredient used in sunscreen, was present in four Neutrogena sunscreens, as well as one Aveeno product. Long-term exposure to benzene can cause leukemia and other cancers.

July 2–8

  • The World Health Organization (WHO) released new guidelines for cervical cancer screening (available at https://www.who.int). The agency recommends human papillomavirus (HPV) DNA testing rather than Pap testing or visual inspection with acetic acid, citing the test’s greater accuracy and simplicity, as well as its ability to detect the high-risk strains of HPV that cause most cervical cancers. The WHO also recommends greater access to self-sampling for testing, as well as earlier—starting at age 25 instead of 30—and more frequent screening for women with HIV, who are more likely to develop cervical cancer.
  • The FDA finalized guidance on evaluating cancer drugs in patients with brain metastases (https://www.fda.gov/media/141507/download). The document provides recommendations for designing trials to test cancer agents in these patients—including how to decide which patients to include, how to factor in previous treatments, how to assess brain metastases, and how to select study endpoints. It also notes when drug labels should describe the effects of treatment on central nervous system metastases.
  • Merck announced that the FDA expanded the approval for pembrolizumab (Keytruda) to include patients with locally advanced cutaneous squamous cell carcinoma that cannot be treated with surgery or radiation. The expanded approval is based on the phase II KEYNOTE-629 trial, in which 50% of patients responded to the drug, and 81% of responses lasted for at least 6 months. The drug is already approved for patients with recurrent or metastatic disease who lack other treatment options.
  • Researchers reported that racial disparities in breast cancer screening have worsened during the COVID-19 pandemic (Cancer Cell 2021 July 1 [Epub ahead of print]). After a substantial decrease in breast cancer screening between March and June 2020, it rebounded to prepandemic levels between September and December 2020. However, this was not the case for Black and Hispanic women, who were less likely to have mammograms during this period than they were before the pandemic.
  • Bayer and Onyx Pharmaceuticals jointly filed suit against Dr. Reddy’s Laboratories over its proposed generic version of Nexavar (sorafenib), an FDA-approved multikinase inhibitor for certain thyroid, liver, and kidney cancers. According to the complaint, Dr. Reddy’s submitted an Abbreviated New Drug Application for approval of the generic version in May, thus suggesting that the Bayer–Onyx Nexavar patent is invalid or would not be infringed upon by the generic.
  • Regulators in 14 European countries have failed to ensure publication of a significant amount of trial data. Results are missing from at least 5,976 single-country clinical trials, mostly from studies in Italy (1,221), Spain (884), and the Netherlands (839). Additionally, results reporting was especially poor in the Netherlands—just 10% of trials—followed by Italy and France, both at 17%. The report, published by Transparency International France, Health Action International, Melanoma Patient Network Europe, and TranspariMED, is available at http://freepdfhosting.com/3b527e1675.pdf.

June 2021

June 25–July 1

  • JUUL agreed to pay North Carolina $40 million to settle a lawsuit involving the company’s electronic cigarettes (e-cigarettes). The state argued that JUUL’s marketing practices for e-cigarettes led to widespread nicotine addiction among young people. Thirteen other states have filed similar lawsuits against JUUL, along with almost 2,000 cases filed by cities, counties, school districts, and other entities.
  • Iovance Biotherapeutics' LN-145 may have activity against relapsed/refractory metastatic non–small cell lung cancer (NSCLC). In the IOV-COM-202 basket trial, six of 28 patients with NSCLC responded to the therapy, and 12 more experienced stable disease. A tumor-infiltrating lymphocyte therapy, LN-145 has previously elicited responses in melanoma and cervical cancer.
  • BeiGene's PD-1 inhibitor tislelizumab may benefit patients with inoperable hepatocellular carcinoma who have received prior therapies, according to research reported at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer 2021. In a phase II trial, 12.4% of patients responded to the drug; median overall survival (OS) was 12.4 months and median progression-free survival was 2.7 months.
  • The FDA approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals) as a component of multiagent chemotherapy for patients with acute lymphoblastic leukemia or lymphoblastic lymphoma who are allergic to asparaginase derived from E. coli. The approval was based on the phase II/III Study JZP458-201 trial, in which 94% of patients achieved the target level of asparaginase activity after being treated with the recommended dose. The approval is expected to help resolve an ongoing shortage of the only other FDA-approved option for such patients.
  • The CD19-directed chimeric antigen receptor therapy axicabtagene ciloleucel (Yescarta; Kite) may lead to better responses than standard therapy in patients with relapsed/refractory large B-cell lymphoma. In the ZUMA-7 trial, the therapy significantly extended event-free survival and increased the response rate compared with chemotherapy and a stem cell transplant—and patients trended toward longer OS.
  • Researchers reported that screening for breast and cervical cancers dropped dramatically after the COVID-19 pandemic began (Preventive Medicine 2021;151:106559). In April 2020, breast cancer screening declined by 87% and cervical cancer screening decreased by 84%, compared with the previous 5-year averages for the month. However, screening rates had started to recover by June 2020, when the study period ended.
  • Two organizations called for the inclusion of patients with cancer in COVID-19 vaccine trials in a joint statement available at https://www.asco.org/. The American Society of Clinical Oncology and Friends of Cancer Research pointed out that patients with cancer may be more vulnerable to COVID-19 than healthy people, but they have almost universally been excluded from vaccine trials, making it difficult to assess whether vaccines are safe and effective for them.

June 18–24

  • NIH director Francis Collins, MD, PhD, and Eric Lander, PhD, director of the Office of Science and Technology Policy, and others described the thinking behind the Advanced Research Projects Agency for Health (ARPA-H) within the NIH (Science 2021 Jun 22 [Epub ahead of print]). President Joe Biden proposed creating ARPA-H "to develop breakthroughs—to prevent, detect, and treat diseases like Alzheimer’s, diabetes, and cancer," and requested $6.5 billion to fund it in the 2022 fiscal year budget. Inspired by the Defense Advanced Research Projects Agency, ARPA-H would stress flexibility, nimbleness, speed, and efficiency in advancing biomedical research.
  • The FDA Oncologic Drugs Advisory Committee voted 13 to 4 to defer a recommendation on retifanlimab (MGA012; MacroGenics) for anal cancer until more data are available. In the phase II POD1UM-202 trial, 14% of patients with locally advanced or metastatic anal cancer previously treated with platinum-based chemotherapy responded to the PD-1 inhibitor. The committee is awaiting results from the phase III POD1UM-303 trial.
  • Researchers identified mutations in children with rhabdomyosarcoma that may be linked to poorer survival (J Clin Oncol 2021 Jun 24 [Epub ahead of print]). They performed next-generation sequencing on samples from 641 patients with the disease enrolled in clinical trials between 1995 and 2017. They found that patients with TP53 or MYOD1 mutations had shorter event-free survival than those without the mutations, and TP53 alterations were associated with more aggressive disease.
  • Corcept Therapeutics announced it will halt a phase III trial testing the antiglucocorticoid relacorilant plus chemotherapy in patients with metastatic pancreatic cancer who had already received treatment. In the trial, two of 31 evaluable patients responded, suggesting that the combination is active but not sufficiently beneficial to warrant additional study. The company will continue to investigate the drug in other solid tumors.
  • The FDA released a draft guidance on expanding eligibility for oncology trials (https://www.fda.gov/media/150244/download). The document provides recommendations for designing trials that include patients with incurable cancer who have not yet received treatment, with the goal of increasing therapeutic options for these patients. The guidance is available for comment until August 24.
  • AbbVie announced it will exercise its right to acquire TeneoOne for an undisclosed sum. The deal centers on TeneoOne’s CD3/BCMA-targeting bispecific TNB-383B, which elicited an objective response rate of 79% in a phase I trial of relapsed/refractory multiple myeloma. AbbVie partnered with TeneoOne to develop TNB-383B in February 2019.

June 11–17

  • In a deal worth at least $650 million, including $200 million in expenses, Bristol Myers Squibb will collaborate with Eisai to develop and commercialize MORAb-202, an antibody–drug conjugate that combines Eisai’s antifolate receptor alpha (FRα) antibody and its anticancer agent eribulin using an enzyme-cleavable linker. Eisai is investigating the agent in FRα-positive solid tumors, including endometrial, ovarian, lung, and breast cancers, in early-phase trials in Japan and the United States. Eisai is entitled to receive up to $2.45 billion more in milestone payments.
  • iTeos Therapeutics and GlaxoSmithKline (GSK) announced an agreement to jointly develop and commercialize EOS-448, an anti-TIGIT monoclonal antibody being investigated in a phase I trial as a treatment for patients advanced solid tumors. TIGIT, part of the CD226 checkpoint axis, has demonstrated potential as a target for the next generation of immune-oncology therapies. Under the deal—which will give GSK access to antibodies that synergistically target TIGIT, CD96, and PVRIG, the three known CD226 checkpoints—iTeos will receive an up-front payment of $625 million with up to $1.45 billion more for meeting development and commercial milestones.
  • The FDA greenlighted avapritinib (Ayvakit; Blueprint Medicines) for adults with advanced systemic mastocytosis (AdvSM), including those with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast cell leukemia. The approval was based on results of the EXPLORER and PATHFINDER trials, which enrolled patients with AdvSM. The overall response rate in both trials combined was 57%, split almost evenly between complete and partial responses. The median duration of response was 38.3 months, and the median time to response was 2.1 months.
  • Oncologists should offer 1 year of adjuvant olaparib to patients with high-risk early-stage HER2-negative breast cancer and germline BRCA1/2 mutations following the completion of (neo)adjuvant chemotherapy and local treatment, including radiation, according to recommendations updating a 2020 guideline from the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology. The recommendation is based on the OlympiA trial, which demonstrated a significant improvement in invasive and disease-free survival with the PARP inhibitor compared with placebo.
  • Some patients with ovarian cancer are more likely to beat the disease if they have surgery prior to receiving chemotherapy instead of the other way around, according to a just-published analysis (PNAS 2021;118:e2026663118). Due to ongoing debate about the sequencing of therapies, researchers built a mathematical model, combined with clinical data from patients, to determine the best approach. For patients who were well enough to undergo an operation, surgery proved superior because it offers the best chance to remove cells likely to be resistant to chemotherapy, the researchers said.

June 4–10
This week: Special content from the 2021 ASCO meeting and other news

  • At the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, researchers presented results indicating that the second-generation BTK inhibitor acalabrutinib (Calquence; AstraZeneca) has similar efficacy as ibrutinib (Imbruvica; Janssen) but is better tolerated in patients with previously treated chronic lymphocytic leukemia. In the phase III ELEVATE-RR trial, patients in both groups had a median progression-free survival (PFS) of 38.4 months. However, those treated with acalabrutinib were less likely to experience cardiac side effects, as well as grade 3 or higher adverse events (AE)—and were less likely to discontinue treatment or die due to AEs.
  • A pair of clinical trials suggest that Loxo Oncology’s TRK inhibitor larotrectinib (Vitrakvi) may be active in pediatric and adult patients with central nervous system (CNS) tumors and TRK fusions. In combined results from the NAVIGATE and SCOUT trials, the drug elicited responses in 10 of 33 patients, leading to a median PFS of 18.3 months; median overall survival (OS) was not reached. "These results support testing for NTRK gene fusions for all patients with CNS tumors, especially if there is no known driver," concluded Sébastien Perreault, MD, of CHU Sainte Justine in Montreal, Canada, who presented the results at the ASCO meeting.
  • At the ASCO meeting, researchers reported that Immunogen’s mirvetuximab soravtansine (IMGN853) plus bevacizumab (Avastin; Genentech) may benefit patients with recurrent ovarian cancer and high folate receptor alpha (FRα) expression. In a phase I/II trial, the combination elicited responses in 21 of 33 patients with FRα-high disease, and responses lasted for a median of 11.8 months; patients had a median PFS of 10.6 months. Mirvetuximab soravtansine is an antibody–drug conjugate that targets FRα in tumor cells and delivers tubulin-targeting maytansinoid DM4.
  • The PD-1 inhibitor toripalimab (Junshi Biosciences) plus chemotherapy may be an effective first-line treatment in patients with locally advanced, recurrent, or metastatic nasopharyngeal carcinoma. In the phase II JUPITER-02 trial, patients treated with the combination had a median PFS of 11.7 months and a 1-year PFS of 49%, compared with 8 months and 28%, respectively, in those who received chemotherapy alone. Findings were presented at the ASCO meeting.
  • "Over the last 20 years, we hit a glass ceiling in the first-line systemic treatment of advanced esophageal cancers, and apart from those cancers that were amplified for HER2, there was relatively little progress," said David Cunningham, MD, of the Royal Marsden NHS Foundation Trust in the UK, during the ASCO meeting. However, based on the results of the ESCORT-1st and CheckMate 648 studies, he said that a combination of immunotherapy and chemotherapy or dual immunotherapies should be deemed standard-of-care first-line treatment for esophageal squamous cell carcinoma.
  • Adding 177Lu-PSMA-617 to standard-of-care therapy may improve survival in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer who have received other therapies. In the phase III VISION trial, patients treated with the agent plus standard-of-care therapy had a median radiographic PFS of 8.7 months and a median OS of 15.3 months, compared with 3.4 months and 11.3 months, respectively, in those who received standard-of-care therapy alone. 177Lu-PSMA-617 is a radionuclide that targets PSMA-expressing cancer cells with beta radiation. Results were presented at the ASCO meeting.
  • A 70-gene signature may identify patients with inoperable invasive breast cancer who are unlikely to relapse. In the phase III MINDACT trial, 1,000 women classified by the MammaPrint signature as having an ultralow risk of recurrence had an 8-year distant metastasis-free interval of 97% and an 8-year breast cancer–specific survival of 99.6%. "These patients could be candidates for further de-escalation of treatments, thus further reducing overtreatment and the risk of side effects," concluded Josephine Lopes Cardozo, MD, of the Netherlands Cancer Institute in Amsterdam, who presented the results at the ASCO meeting.
  • Also at the ASCO meeting, researchers reported early signs of activity for CYT-0851 (Cyteir) in patients with relapsed/refractory hematologic malignancies and advanced solid cancers. In a phase I trial, three of 21 evaluable patients responded to the drug—including patients with diffuse large B-cell lymphoma, follicular lymphoma, and soft-tissue sarcoma—and 10 more patients experienced stable disease. CYT-0851 is a small-molecule inhibitor of RAD51-mediated homologous recombination.
  • Cardinal Health Nuclear & Precision Health Solutions announced that the radioactive diagnostic agent Lymphoseek has been approved by the FDA for use in children. In addition to adult use, the new indication will provide an efficient, accurate, and safe way to enhance lymphatic mapping and guide sentinel lymph node biopsies in children with melanoma, rhabdomyosarcoma, or other solid tumors.

May 28–June 3

  • The FDA granted accelerated approval to sotorasib (Lumakras; Amgen) for patients with KRASG12C-mutated non–small cell lung cancer who have already received at least one therapy. In the phase II CodeBreak 100 trial, which formed the basis of the approval, the drug elicited an objective response rate (ORR) of 36% and a median duration of response (DoR) of 10 months. Sotorasib is the first KRAS inhibitor to be approved by the FDA.
  • The agency also granted accelerated approval to infigratinib (Truseltiq; BridgeBio Pharma) for patients with locally advanced or metastatic cholangiocarcinoma who have an FGFR2 fusion or other rearrangement and previously received other therapies. The decision was based on a phase II trial in which 108 patients had an ORR of 23% and a median DoR of 5 months. The approval is the first for infigratinib, an FGFR tyrosine kinase inhibitor.
  • MorphoSys announced it will acquire Constellation Pharmaceuticals for $1.7 billion. Constellation’s lead candidate is the BET inhibitor pelabresib (CPI-0610), which is being tested in a phase III trial in patients with myelofibrosis. The company is also developing the second-generation EZH2 inhibitor CPI-0209, which is being investigated in a phase II trial in solid and hematologic malignancies.
  • Bristol Myers Squibb (BMS) is being sued for $6.4 billion over its CAR T-cell therapy lisocabtagene maraleucel (Breyanzi) that was approved for large B-cell lymphoma in February 2021. According to the complaint, the company failed to make the required "diligent efforts" to seek FDA approval of the drug by a deadline of December 31, 2020, and thus avoided paying the sum to Celgene shareholders. BMS bought Celgene for $80.3 billion in November 2019.
  • AstraZeneca’s PARP inhibitor olaparib (Lynparza) may be an effective adjuvant therapy for patients with high-risk HER2-negative early breast cancer and a BRCA1/2 mutation who have had surgery and received neoadjuvant or adjuvant chemotherapy (N Engl J Med 2021 Jun 3 [Epub ahead of print]). At a median follow-up of 2.5 years in the phase III OlympiA trial, patients treated with the drug had an estimated 3-year invasive disease-free survival (DFS) rate of 85.9% and a 3-year distant DFS of 87.5%, compared with 77.1% and 80.4%, respectively, in patients who received a placebo. Findings will be presented at the 2021 American Society of Clinical Oncology Annual Meeting on June 6.

May 2021

May 21–27

  • The FDA granted accelerated approval to amivantamab-vmjw (Rybrevant; Janssen) for patients with non–small cell lung cancer and EGFR exon 20 insertion mutations who have already received platinum-based chemotherapy. The approval was based on the phase I CHRYSALIS trial, in which 81 patients had an overall response rate of 40% and a median duration of response of 11.1 months. Amivantamab-vmjw is a bispecific antibody that targets EGFR and MET.
  • U.S. legislators introduced the Long-term Opportunities for Advancing New Studies (LOANS) for Biomedical Research Act, which would authorize $30 billion over 3 years to support research in areas of unmet medical need, as well as research affected by the COVID-19 pandemic. The money would back so-called “BioBonds” of up to $25 million that would be given to small companies and universities. The legislation needs to be approved by the Senate and House of Representatives before it becomes law.
  • The U.S. Supreme Court declined to review a federal appeals court decision to include two U.S. scientists on eight immunotherapy patents. The scientists—Gordon Freeman, PhD, of Dana-Farber Cancer Institute in Boston, MA, and Clive Wood, PhD, of Boehringer Ingelheim—will be added to the patents, which were previously issued to Ono Pharmaceutical and Tasuku Honjo, MD, PhD, of Kyoto University in Japan. The patents describe the PD-1 pathway that is central to the development of PD-1/PD-L1 inhibitors.
  • The FDA published a final guidance on the development of bispecific antibodies (https://www.fda.gov/media/123313/download). The document outlines considerations and recommendations for pharmacology and manufacturing, as well as preclinical and clinical testing of the therapies. It also discusses differences in developing bispecific and monoclonal antibodies. Currently, blinatumomab (Blincyto; Amgen) and amivantamab-vmjw are the only bispecific antibodies approved for cancer, although various others are in clinical trials.
  • The agency also released a guidance on implementation of the Research Acceleration for Cure and Equity for Children Act. The 2017 act requires trial sponsors to evaluate molecularly targeted cancer drugs for adults in children if the same target is present (https://www.fda.gov/media/133440/download). Among other things, the guidance offers information about waivers and deferrals, describes safeguards for children enrolled in trials, and specifies the sources used to develop lists of relevant molecular targets.
  • A study revealed that the reporting of results from oncology trials has increased over the past 10 years (JAMA Netw Open 2021;4:e2110438). Researchers analyzed 12,240 oncology trials registered on ClinicalTrials.gov between 2007 and 2017 that were completed or terminated before September 2017. They found that results were reported for 60.7% of trials, and the 24-month reporting rate increased by 34% during the study period; more recent and larger trials were more likely to have results reported, as were those funded by the NIH.

May 14–20

  • The U.S. Preventive Services Task Force recommended colorectal cancer screening for people ages 45 to 70 (JAMA 2021;325:1965–77). Previously, the agency recommended that screening start at age 50. The change was based on research demonstrating the benefits of earlier screening, as well as a rising number of cases of early-onset colorectal cancer, defined as cancer diagnosed before age 50.
  • Bristol Myers Squibb (BMS) announced that the FDA approved its PD-1 inhibitor nivolumab (Opdivo) for patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after surgery and neoadjuvant chemoradiotherapy. The approval was based on the phase III CheckMate-577 trial, in which nivolumab led to a median disease-free survival (DFS) of 22.4 months, compared with 11 months in the placebo arm.
  • At a press preview for the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, researchers reported that atezolizumab (Tecentriq; Roche) following surgery and chemotherapy may stave off recurrence of non–small cell lung cancer. In the phase III IMpower010 trial, patients treated with the PD-L1 inhibitor had a median DFS of 42.3 months, compared with 35.3 months in patients who received best supportive care. The ASCO meeting will be held virtually June 4–8.
  • BMS announced a $200 million deal with Agenus that could be worth up to $1.36 billion more in milestone payments. BMS will acquire rights to Agenus’s anti-TIGIT agent AGEN1777, which is in preclinical testing for various solid cancers. BMS is also developing its own anti-TIGIT drug, BMS-986207.
  • An American Cancer Society review of cancer prevention and early detection measures concluded that smoking reached a historic low of 14% in 2019 (Cancer Prevention & Early Detection Facts & Figures 2021-2022). However, cancer screening could be improved: In 2018, 63% of eligible women were up to date with breast screening and 84% with cervical cancer screening; 66% of eligible adults were up to date with colorectal cancer screening. Only 5% to 6% of eligible adults received lung cancer screening.
  • The Cancer Prevention & Research Institute of Texas in Austin awarded $69.5 million in grants to researchers at Texas institutions, including Baylor College of Medicine in Houston and The University of Texas at Austin. Some of the money will be used to expand existing cancer prevention programs for people who lack sufficient access to medical care, focusing on tobacco cessation, mammography, and colorectal cancer screening.

May 7–13

  • Clovis Oncology's rucaparib (Rubraca) may be effective in patients with advanced pancreatic cancer who have a BRCA1/2 or PALB2 mutation (J Clin Oncol 2021 May 10 [Epub ahead of print]). Patients who received the PARP inhibitor following platinum-based chemotherapy in a phase II trial had a median progression-free survival (PFS) of 13.1 months and a median overall survival of 23.5 months.
  • Preliminary results announced by AstraZeneca/Daiichi Sankyo suggest that the TROP2-directed antibody–drug conjugate datopotamab deruxtecan (DS-1062) may be active in patients with metastatic triple-negative breast cancer (TNBC) who have received other therapies. In the phase I TROPION-PanTumor01 trial, five of 21 evaluable patients responded to the drug, and four more responses are awaiting confirmation; 11 patients experienced stable disease. Findings were presented at the 2021 European Society of Medical Oncology Breast Cancer Virtual Congress.
  • Genentech's BRAF inhibitor vemurafenib (Zelboraf) and anti-CD20 agent rituximab (Rituxan) may lead to durable responses in hairy-cell leukemia (N Engl J Med 2021;384:1810–23). In a phase II trial, the drug elicited complete responses in 26 of 30 patients with relapsed/refractory disease, and 17 of those patients were negative for minimal residual disease. The PFS rate was 78% at a median of 37 months, and 85% of patients who responded were relapse-free at a median follow-up of 34 months.
  • The launch of a translational research platform to study rare cancers was announced. The effort is a collaboration between The University of Texas MD Anderson Cancer Center in Houston and the Broad Institute of MIT and Harvard in Cambridge, MA. Its researchers aim to generate more than 100 rare cancer models linked to comprehensive molecular data that will be available to the research community.
  • African American women with TNBC may have a higher mortality rate than their white counterparts (JAMA Oncol 2021 May 13 [Epub ahead of print]). Researchers conducted a retrospective analysis of 23,123 women diagnosed with nonmetastatic TNBC between 2010 and 2015, 25.3% of whom were African American. They found that African American women had a 28% increased risk of death compared with white women, and that this disparity was in part due to lower rates of surgery and chemotherapy.
  • Dana-Farber Cancer Institute (DFCI) in Boston, MA, received a $50 million donation to study pancreatic cancer. The money will be used to purchase laboratory equipment for in-depth research on the biology of pancreatic tumors. The gift is from the Judith B. Hale, her son, Robert T. Hale Jr., and his wife, Karen Hale; the family has now contributed more than $80 million to DFCI.

April 30–May 6

  • The FDA granted accelerated approval to the PD-1 inhibitor pembrolizumab (Keytruda; Merck) plus trastuzumab (Herceptin; Genentech) and chemotherapy in patients newly diagnosed with certain HER2-positive gastric or gastroesophageal cancers. In the phase III KEYNOTE-811 trial, patients treated with the investigational combination had an overall response rate of 74%, compared with 52% in patients who received trastuzumab plus chemotherapy. In April, an FDA advisory committee recommended revoking accelerated approval of pembrolizumab monotherapy as a third-line option in these patients, citing little evidence of benefit and the upcoming first-line approval.
  • AstraZeneca/Daiichi Sankyo’s trastuzumab deruxtecan (Enhertu) may be effective in HER2-positive metastatic colorectal cancer (Lancet Oncol 2021 May 4 [Epub ahead of print]). In the phase II DESTINY-CRC01 trial, 53 patients had an objective response rate of 68% and a median progression-free survival of 6.9 months. A HER2-targeted antibody–drug conjugate, trastuzumab deruxtecan is FDA approved for certain HER2-positive breast and gastric cancers.
  • A deep learning algorithm may predict where cancers originate (Nature 2021 May 5 [Epub ahead of print]). During a test run of 6,500 cancers with known primary sites, the model identified the site of origin in 83% of cases and listed the correct diagnosis among its top three predictions in 96% of cases. Of 317 cancers with unknown primary sites for which a differential diagnosis had been assigned, the algorithm agreed with the pathologist in 61% of cases and had top-three agreement in 82% of cases.
  • Pfizer announced a pause in enrollment in the phase I MagnetisMM-3 trial of elranatamab (PF-06863135) in multiple myeloma due to three cases of peripheral neuropathy. The company has also halted a phase II trial of the drug while it provides additional safety information to the FDA. Elranatamab targets BCMA and CD3.
  • Parents and siblings of patients with colorectal polyps may have a higher risk of colorectal cancer (Br J Cancer 2021;373;n877). Researchers analyzed data from 68,060 patients with colorectal cancer and 333,753 matched controls. They found that 8.4% of patients with the disease had a first-degree relative with colorectal polyps, compared with 5.7% of healthy participants; the risk of colorectal cancer was even more pronounced in those who had at least two first-degree relatives with polyps, or a relative who developed polyps at a young age.
  • Researchers have developed a fluorescent imaging system based on the visual system of mantis shrimp to assist surgical oncologists as they operate (Sci Transl Med 2021;13:eaaw7067). The system, which consists of layers of silicon photodetectors and spectral filters stacked into a single chip, can detect multiple colors and near-infrared light. In mice with human prostate tumors, the system distinguished cancer cells from healthy tissue in 92% of cases; in 18 patients with breast cancer, it helped surgeons map lymph nodes close to tumors.

April 2021

April 23–29

  • The FDA's Oncologic Drugs Advisory Committee voted to maintain accelerated approvals for four of six immunotherapy indications that were under review. The favorable votes were for the use of pembrolizumab (Keytruda; Merck) in hepatocellular carcinoma and urothelial carcinoma, and atezolizumab (Tecentriq; Genentech) in triple-negative breast cancer and urothelial carcinoma; the committee voted against pembrolizumab to treat gastric cancer and nivolumab (Opdivo; Bristol Myers Squibb) to treat hepatocellular carcinoma. The FDA doesn’t need to follow the committee's recommendation, although it usually does so.
  • The FDA granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics) in patients with relapsed/refractory large B-cell lymphoma who have received at least two other therapies. The approval was based on the phase II LOTIS-2 trial, in which patients had an overall response rate of 48.3% and a median duration of response of 10.3 months. The agent is a CD19-targeting antibody–drug conjugate.
  • The agency also announced it plans to ban menthol cigarettes and all flavored cigars within the next year. "Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products," said Acting FDA Commissioner Janet Woodcock, MD, noting higher rates of use among communities of color, people with low income, and LGBTQ+ individuals.
  • The FDA issued a Notice of Noncompliance to Acceleron Pharma for not reporting trial results to clinicaltrials.gov. The company now has 30 days to upload findings to the site, after which it could be fined up to $10,000 per day. The notice is the first issued by the FDA to enforce a Health and Human Services Department rule finalized in 2016, although the agency has sent more than 40 warnings to other companies.
  • Young men are less likely to receive the human papillomavirus vaccine than young women, researchers reported (JAMA 2021;325:1673–4). Researchers reviewed vaccination data for 18- to 21-year-olds gathered by the National Health Interview Survey from 2010 to 2018. They found that, overall, 42% of females and 16% of males received at least one dose of the vaccine; in 2010, 32% of females and 2% of males received at least one dose, compared with 55% and 34%, respectively, in 2018.
  • Galera announced that avasopasem (GC4419) may improve the effectiveness of stereotactic body radiation in patients with locally advanced pancreatic cancer. In a phase I/II trial, patients treated with the agent plus radiotherapy had a median overall survival of 20.1 months and a response rate of 29%, compared with 10.9 months and 11% in patients who received radiotherapy alone. Avasopasem is a dismutase mimetic designed to convert superoxide into hydrogen peroxide and oxygen, thus protecting normal tissue from damage during radiotherapy.

April 16–22

  • The FDA granted accelerated approval to dostarlimab-gxly (Jemperli; GlaxoSmithKline) for patients with mismatch repair–deficient recurrent or advanced endometrial cancer who have already received chemotherapy. The approval of the PD-1 inhibitor was based on the single-arm GARNET trial, in which patients had an overall response rate of 42.3%, and 93.3% of patients responded for at least 6 months.
  • Bristol Myers Squibb announced that the FDA approved nivolumab (Opdivo) plus chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma—regardless of PD-L1 expression. The PD-1 inhibitor’s approval was based on the CHECKMATE-649 trial, in which patients treated with the combination had a median progression-free survival (PFS) of 7.7 months and a median overall survival (OS) of 14.4 months, compared with 6 months and 11.1 months, respectively, in patients who received chemotherapy alone.
  • The antibody–drug conjugate sacituzumab govitecan (Trodelvy; Immunomedics) may be effective in patients with relapsed/refractory triple-negative breast cancer (N Engl J Med 2021;384:1529–41). In the phase III ASCENT trial, patients treated with the agent had a median PFS of 5.6 months and a median OS of 12.1 months, compared with 1.7 months and 6.7 months, respectively, in patients who received chemotherapy. The FDA recently approved sacituzumab govitecan to treat these patients.
  • According to results of the ongoing phase I/II AUGMENT-101 trial, the menin inhibitor SNDX-5613 (Syndax) may be effective in patients with MLL rearranged or NPM1 mutant relapsed/refractory acute leukemias. In the trial, 15 of 31 evaluable patients responded to the drug, and 10 responders were minimal residual disease–negative; responses were seen in 13 of 24 patients with MLL rearranged disease.
  • A group of public and private cancer organizations announced the formation of a Multi-Cancer Early Detection Consortium. The consortium will evaluate the clinical and public health value of new cancer detection technologies and establish standards for using such technologies in routine medical care. More than 35 organizations have joined so far; founding members include Dana-Farber Cancer Institute in Boston, MA, Stand Up To Cancer, and Grail, among others.
  • Researchers launched the DiRECT study to investigate racial differences in response to immune checkpoint inhibitors. Led by New York’s Roswell Park Comprehensive Cancer Center in Buffalo and Wilmot Cancer Institute at the University of Rochester Medical Center, the study aims to enroll 600 Black patients and 1,200 white patients of European ancestry treated with immunotherapy. The project is supported by a 2-year, $2.08 million NCI grant.
  • Janssen Pharmaceuticals will not pursue FDA approval of the androgen receptor inhibitor apalutamide (Erleada) plus abiraterone acetate (Zytiga) and prednisone in patients with metastatic castration-resistant prostate cancer who have not received chemotherapy. The decision came after the triplet failed to improve OS compared with abiraterone acetate and prednisone alone in the phase III ACIS trial.

April 9–15
This week: Special content from the AACR Annual Meeting 2021 and other news

  • NCI Director Norman "Ned" Sharpless told attendees of the American Association for Cancer Research (AACR) Annual Meeting 2021 that progress must speed up dramatically. To cut the cancer mortality rate in half from its peak in the early 1990s, "will require a considerable acceleration of what we’ve been able to achieve in the last few decades," he said. At the current rate of 2.2% per year, it would take until 2040 to reach that goal—"that’s too long… Using all of our many tools of prevention and screening and new therapies, I think we can get there by 2026—that’s 5 years from now. This would require an average reduction in cancer mortality of about 4% per year, which is considerably faster than the rate of decline we’ve ever done before."
  • In a high-level outline of its budget priorities for fiscal year 2022 released on April 9, the Biden Administration proposed a total increase of $9 billion for the NIH. Of that, $2.5 billion would be distributed to the NIH’s various institutes, of which the NCI is the largest, Sharpless reported. If approved by Congress, "that would translate into a substantial increase in the NCI’s budget for FY2022. This would be key to allowing the NCI to continue to increase paylines and success rates for grant applications."
  • Aiming to cure major diseases, including cancer and diabetes, the Biden Administration proposed creating a $6.5 billion medical research agency that would be "housed" within the NIH. The Advanced Research Projects Authority for Health would be modeled after the Defense Advanced Research Projects Agency, wherein funding decisions are made by program managers rather than peer reviewers, and projects receive milestone-driven payments instead of multiyear grants.
  • During the AACR meeting, Melissa Davis, PhD, of Weill Cornell Medical College in New York, NY, discussed how a lack of genomic data from diverse populations can lead to disparities in cancer research. "Just about any population that is of non-European descent has a higher rate of reporting back on a mutation panel a variant of unknown significance," she said. These panels are used to determine eligibility for trials, she added, so "if their mutations are undefined and therefore by definition unknown and unactionable, this a systematic exclusion of these individuals for their access to trials."
  • The director of the Cold Spring Harbor Laboratory Cancer Center in New York, David Tuveson, MD, PhD, was inaugurated as president of the AACR on April 12, succeeding Antoni Ribas, MD, PhD, of the University of California, Los Angeles, Jonsson Comprehensive Cancer Center. Lisa Coussens, PhD, of the Knight Cancer Institute at Oregon Health & Science University in Portland, will become the organization’s president following Tuveson’s 1-year term.
  • At the AACR meeting, Eric Klein, MD, of Ohio’s Cleveland Clinic reported data from a prospective study on Galleri, GRAIL’s multicancer early detection test. Researchers assessed Galleri, which relies on sequencing of methylation regions in circulating cell-free DNA to detect malignancies, on 2,823 patients with cancer and 1,254 healthy people. The assay had a specificity of 99.5% and a sensitivity of 51.5% across cancer types and stages; sensitivity increased with cancer stage. Among patients who tested positive for cancer, Galleri accurately determined the tissue of origin in 88.7% of cases. "These data support the foundation for population-scale clinical implementation of this test," Klein concluded.
  • Engineered natural killer (NK) cells can target specific antigens via expression of chimeric antigen receptors (CAR). As an alternative approach to endow NK cells with CAR-like activity, Katayoun Rezvani, MD, PhD, of The University of Texas MD Anderson Cancer Center in Houston, reported the generation of cord blood–derived NK cells precomplexed prior to infusion with AFM13 (Affimed), a bispecific innate cell engager that binds CD16 on NK cells and CD30 on tumor cells. Preliminary results from a phase I trial indicate that adoptive transfer of AFM13-complexed CAR-like NK cells shows antitumor activity with minimal toxicity in patients with relapsed/refractory CD30+ Hodgkin lymphoma.
  • Tumor heterogeneity can make it difficult to determine which tumors are immunologically "hot" and thus more likely to respond to immunotherapy. Elisabeth De Vries, MD, PhD, and colleagues at the University Medical Center Groningen in the Netherlands explored whole-body PET imaging and reported that tumor uptake of radiolabeled PD-1 antibodies is associated with prolonged progression-free and overall survival. "Whole body information about what’s happening at the tumor and normal tissue level might provide insights into what’s happening during the complex processes induced by immunotherapy," she told AACR meeting attendees.
  • Also at the AACR meeting, Ross Levine, MD, of Memorial Sloan Kettering Cancer Center in New York, NY, outlined studies demonstrating the power of single-cell sequencing technology to precisely identify the timing of mutations and define clonal trajectories. Follow-up studies have shown that clonal genotypes are associated with distinct immunophenotypes, he said, and advances in in vivo modeling and multi-omics single-cell sequencing will provide insight into the mechanisms underlying evolutionary mutational trajectories and enable elucidation of the biological underpinnings of clonal hematopoiesis.
  • Michel Sadelain, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, NY, described several advances in chimeric antigen receptor (CAR) T-cell therapy that might improve its efficacy—modulation of transcriptional regulation, signaling calibration, and epigenetic enhancement. He also introduced a novel CAR design called HIT receptor and demonstrated its greater antigen sensitivity compared with "traditional" CAR T-cell therapy.
  • The 4-1BB (CD137)/HER2 bispecific cinrebafusp alfa (PRS-343; Pieris) may be active in patients with HER2-expressing cancers who have previously received multiple therapies. In a phase I trial presented at the AACR meeting, five of 42 evaluable patients responded to the therapy, and 17 more patients experienced stable disease; two of the responses—including one complete response—were in eight patients treated at the highest dose level. The agent increased CD8+ T cells, NK cells, and cytotoxic activity in the tumor microenvironment.
  • Researchers described the discovery of INCB89550, a PD1/PD-L1 inhibitor at the AACR meeting that is being tested in clinical trials. Using high-throughput screening, the team initially identified a compound that exhibited dose-dependent inhibition of PD-1–PD-L1 interactions. Analysis of the amino acid residues critical for drug activity revealed that the inhibitor blocked binding by interacting with PD-L1 directly at the PD-1–PD-L1 binding interface—a rare occurrence because this interface is largely flat and lacks a defined binding pocket. The researchers then used rational, structure-guided design of improved inhibitors derived from the initial hit to identify INCB086550 as a candidate for clinical development.
  • Also at the AACR meeting, researchers reported promising preclinical results for the targeted thorium conjugate HER2-TTC (BAY2701439; Bayer). The agent consists of a radioactive thorium isotope bound by a chelator that is covalently linked to a HER2 antibody. It kills HER2-expressing cells and neighboring cells by delivering alpha radiation that induces DNA damage—for which there is no known resistance mechanism. Preclinical results suggest that HER2-TTC may have anti-tumor activity in cancers with low levels of HER2 expression, as well as those that are resistant to other HER2-targeted agents. The agent is now being tested in a phase I trial of HER2-expressing malignancies.

  • In other news:

  • The FDA authorized the marketing of the artificial intelligence device GI Genius (Cosmo Artificial Intelligence), which assists clinicians in detecting lesions during a colonoscopy. In a prospective trial of patients with adenoma or carcinoma, the technology identified lesions in 55.1% of cases, compared with a 42% detection rate for colonoscopy alone. The device, which uses a machine learning algorithm, attaches to an endoscope and identifies regions of interest in the colon, alerting clinicians to take a closer look.
  • The agency also granted accelerated approval to sacituzumab govitecan (Trodelvy; Immunomedics), an antibody–drug conjugate, for patients with locally advanced or metastatic urothelial cancer who have received chemotherapy and a PD1/PD-L1 inhibitor. The approval was based on the phase II TROPHY trial, in which patients had an objective response rate of 27.7% and a median duration of response of 7.2 months.
  • GlaxoSmithKline (GSK) halted the phase II INDUCE-3 trial testing feladilimab, an inducible T-cell co-stimulatory agonist, plus pembrolizumab (Keytruda; Merck) in head and neck cancer based on the recommendation of an independent data monitoring committee. The company will also discontinue the phase II INDUCE-4 trial assessing feladilimab plus pembrolizumab and chemotherapy in head and neck cancer. GSK did not share details of the committee’s recommendation.

April 2–8

  • Daiichi Sankyo announced it will invest $13.6 billion in new cancer treatments through March 2026, an investment that represents a nearly 70% increase over the previous 5-year period. The company aims to expand the uses for the HER2-targeted antibody–drug conjugate (ADC) trastuzumab deruxtecan (Enhertu), jointly developed with AstraZeneca, beyond breast and gastrointestinal cancers. Also, the company plans to develop other ADCs, including TROP2- and HER3-targeting agents.
  • Researchers suggested that eligibility criteria for some cancer clinical trials could be expanded (Nature 2021 Apr 7 [Epub ahead of print]). They used an artificial intelligence tool called Trial Pathfinder to emulate clinical trials based on electronic health records of 61,094 patients with advanced non–small cell lung cancer. When they broadened enrollment criteria for these hypothetical trials, they found that the pool of eligible patients more than doubled on average, while overall survival (OS) decreased minimally.
  • The FDA upgraded sacituzumab govitecan-hziy’s (Trodelvy; Gilead) accelerated approval to a full approval in patients with locally advanced or metastatic triple-negative breast cancer who aren’t eligible for surgery and have already received at least two therapies. The decision was based on the phase III ASCENT trial, in which the agent led to a median progression-free survival of 4.8 months and a median OS of 11.8 months, compared with 1.7 months and 6.9 months, respectively, in patients who received chemotherapy. Sacituzumab govitecan-hziy consists of a monoclonal antibody against human trophoblast cell-surface antigen 2 conjugated to the topoisomerase I inhibitor SN-38.
  • The agency also approved a biweekly dosing regimen for the EGFR inhibitor cetuximab (Erbitux; ImClone) in patients with EGFR-mutant colorectal cancer or head and neck cancer. The approval was based on pharmacokinetic and real-world data suggesting that patients derive a similar benefit whether they are treated with the drug weekly or receive a larger dose every 2 weeks.
  • Researchers projected that the landscape of cancer incidence and mortality in the United States will change considerably by 2040 (JAMA Network Open 2021;4:e214708). Notably, melanoma incidence will increase, whereas prostate cancer incidence will drop. Additionally, there will be more deaths from pancreatic and liver cancers and fewer deaths from breast cancer. Estimates were made by combining data from the Surveillance, Epidemiology, and End Results Program with projections from the U.S. Census Bureau.

March 2021

March 26–April 1

  • The Federal Trade Commission will seek to stop Illumina’s $7.1 billion acquisition of Grail. The government agency claims that the deal will inhibit the market for blood-based cancer detection tests because Illumina is the only provider of DNA sequencing for such tests. Grail was founded by Illumina in 2016 and later became a stand-alone company.
  • The FDA approved idecabtagene vicleucel (ide-cel, Abecma; Bristol Myers Squibb) for patients with relapsed/refractory multiple myeloma who have already received at least four therapies. In the phase III KarMMA trial, the agent elicited an overall response rate of 72% and a median duration of response of 11 months. Idecabtagene vicleucel is a chimeric antigen receptor (CAR) T-cell therapy that targets B-cell maturation antigen; it is the first CAR T-cell therapy to be approved in multiple myeloma.
  • The agency also approved isatuximab-irfc (Sarclisa; Sanofi) plus carfilzomib (Kyprolis; Amgen) and dexamethasone in relapsed/refractory multiple myeloma. The approval was based on positive results in the phase III IKEMA trial: Patients treated with the triplet did not reach median progression-free survival, compared with 20.3 months in those who received carfilzomib plus dexamethasone. The approval is the first for isatuximab-irfc, a CD38-directed cytolytic antibody.
  • Jazz Pharmaceuticals announced that the FDA expanded the indication for daunorubicin and cytarabine (Vyxeos) to include children age 1 and older newly diagnosed with therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes. The approval was supported by two single-arm trials, AAML 1421 and CPX-MA-1201, in which there were no age-related differences in safety. The agent, a combination of a nucleoside metabolic inhibitor and an anthracycline topoisomerase inhibitor, was approved for adults with AML in 2017.
  • Adjuvant nivolumab (Opdivo; Bristol Myers Squibb) may be effective in esophageal and gastroesophageal junction cancer (N Engl J Med 2021;384:1191–203). In the phase III CheckMate-557 trial, patients treated with the PD-1 inhibitor had a median disease-free survival of 22.4 months compared with 11 months in those who received a placebo.
  • A survey conducted by the American Society for Radiation Oncology found that the COVID-19 pandemic may be causing cancers to be diagnosed at later stages. Sixty-six percent of radiation oncologists said patients are being diagnosed with more advanced cancers than prior to the pandemic, and 73% said patients at their practices are not receiving cancer screenings. Additionally, 66% said patients with cancer have experienced an interruption in radiation therapy.

March 19–25

  • The FDA approved the PD-1 inhibitor pembrolizumab (Keytruda; Merck) plus chemotherapy in patients newly diagnosed with locally advanced or metastatic esophageal junction carcinoma who are not eligible for surgery or chemoradiation. The approval was based on the phase III KEYNOTE-590 trial, in which patients treated with the combination had a median progression-free survival (PFS) of 6.3 months and a median overall survival (OS) of 12.4 months, compared with 5.8 months and 9.8 months, respectively, in patients who received only chemotherapy.
  • Pembrolizumab plus the VEGF inhibitor lenvatinib (Lenvima; Merck) may improve survival in advanced, metastatic, or recurrent endometrial cancer, according to findings presented at the Society of Gynecologic Oncology 2021 Annual Meeting on Women’s Cancer, held virtually March 19–25. In the phase III KEYNOTE-775/Study 309 trial, patients treated with the combination had a median PFS of 7.2 months and a median OS of 18.3 months, compared with 3.8 months and 11.4 months, respectively, in patients who received standard chemotherapy.
  • Novartis announced that the radionuclide 177Lu-PSMA-617 may be effective in patients with metastatic castration-resistant prostate cancer that expresses prostate-specific membrane antigen. In the phase III VISION trial, the agent extended OS and radiographic PFS compared with standard chemotherapy, although the company did not share any data. In a phase II trial, the drug led to a higher objective response rate and prostate-specific antigen response than chemotherapy (The Lancet 2021;397:797–804).
  • Researchers from the COVID-19 and Cancer Consortium reported that Black and Hispanic patients tend to develop more severe COVID-19 infections than white patients (Ann Oncol 2021 Mar 18 [Epub ahead of print]). That conclusion was based on data from 4,966 patients with cancer who developed COVID-19 infections between March and November 2020. Other risk factors associated with more severe COVID-19 included older age, obesity, being male, and comorbidities.
  • Stand Up To Cancer (SU2C) awarded $6 million to a team studying health equity in cancer research. The SU2C Health Equity Breakthrough Team will address underrepresentation of Black and indigenous populations, and people of color in breast, prostate, and liver cancer trials by working with community organizations, training scientists and doctors, and exploring better ways to educate these patients. The team is part of SU2C’s Health Equity Initiative, which launched in January 2020.

March 12–18

  • Sanofi and Regeneron announced that a phase III trial testing cemiplimab (Libtayo) in recurrent or metastatic cervical cancer will be stopped early due to positive results. The decision was made because patients treated with the agent experienced a statistically significant improvement in median overall survival compared with those who received chemotherapy: 12 months versus 8.5 months, respectively. A PD-1 inhibitor, cemiplimab is FDA approved for certain forms of basal cell carcinoma and non–small cell lung cancer.
  • Bintrafusp alfa (GlaxoSmithKline/Merck KGaA) may not be effective as a second-line therapy for patients with locally advanced or metastatic biliary tract cancer (BTC) who have received platinum-based chemotherapy. In a phase II trial, the agent elicited an objective response rate of 10.1%, which failed to meet the predefined threshold for efficacy. A bifunctional fusion protein that blocks TGFβ and PD-L1, bintrafusp alfa will continue to be tested in combination with chemotherapy in BTC.
  • Socioeconomically disadvantaged patients enrolled in cancer clinical trials may fare worse than their more affluent counterparts despite receiving high-quality care during the trials (J Clin Oncol 2021 Mar 17 [Epub ahead of print]). Researchers analyzed data from 41,109 patients with cancer enrolled in 55 phase II and III trials between 1985 and 2012. They found that patients from the poorest neighborhoods had a 28% increased risk of death compared with those from the most affluent areas.
  • A survey revealed that disposable electronic cigarettes (e-cigarettes) are becoming increasingly popular among kids (NEJM 2021 Mar 16 [Epub ahead of print]). Researchers analyzed responses from middle school and high school students gathered during 2019 and 2020. They found that among current e-cigarette users, the use of disposable devices increased from 3% to 15.2% for middle schoolers and from 2.4% to 26.5% for high schoolers.
  • A group of 47 UK charities warned that without government action, the COVID-19 pandemic could cause the UK’s cancer death rate to increase for the first time in decades. The warning highlights delays in cancer screening, diagnosis, and treatment during the pandemic, as well as disruptions to clinical trials. It urges governments to take steps such as directing resources into clearing the backlog of cancer cases, encouraging people with signs of cancer to seek care, and expanding the cancer workforce.
  • Five research teams were awarded Cancer Research UK–Children with Cancer UK Innovation Awards. Each team will receive up to $1.4 million over the next 3 years. With the funding, researchers will tackle projects such as analyzing inherited risk for solid cancers, developing targeted immunotherapy for leukemia in infants, and creating an atlas of rhabdomyosarcoma cases.

March 5–11

  • The FDA approved tivozanib (Fotivda; AVEO Oncology) for patients with relapsed/refractory advanced renal cell carcinoma who have received at least two prior therapies. The approval was based on the phase III TIVO-3 trial, in which patients treated with the agent had a median progression-free survival of 5.6 months and a median overall survival (OS) of 16.4 months, compared with 3.9 months and 19.2 months for patients who received sorafenib. The approval is the first for tivozanib, a VEGF tyrosine kinase inhibitor.
  • The agency also approved axicabtagene ciloleucel (Yescarta; Kite Pharma) in patients with relapsed/refractory follicular lymphoma who have received at least two prior therapies. The approval is based on the phase II ZUMA-5 trial, in which 91% of patients responded to the drug and 74% of patients were in remission at 18 months. A chimeric antigen receptor T-cell therapy, axicabtagene ciloleucel was previously approved for certain types of large B-cell lymphoma.
  • Following a review of recent research, the U.S. Preventive Services Task Force released a final guideline that expands the criteria for lung cancer screening (JAMA 2021;325;962–70). The document calls for screening adults ages 50 to 80 who have a 20 pack-year smoking history and who currently smoke or have quit within the past 15 years. Previously, the agency recommended that screening start at age 55 for people with a 30 pack-year smoking history.
  • Roche will stop marketing the PD-L1 inhibitor atezolizumab (Tecentriq) in the United States for patients with metastatic urothelial carcinoma who have received platinum-based chemotherapy. The decision was made in consultation with the FDA after the agent failed to meet its OS endpoint in the phase III IMvigor211 trial. The FDA had granted atezolizumab accelerated approval in 2016 based on results of the phase II IMvigor210 trial. In late April, the FDA Oncologic Drugs Advisory Committee will convene a meeting to review six other accelerated approvals for PD-1/PD-L1 agents.
  • The Bruton tyrosine kinase (BTK) inhibitor pirtobrutinib (LOXO-305; Loxo Oncology) may be effective in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), mantle cell lymphoma, and other non-Hodgkin lymphomas (Lancet 2021;397:892–901). In the phase I/II BRUIN trial, the agent elicited overall response rates (ORR) ranging from 52% to 71%, depending on the disease; 121 patients with CLL or SLL previously treated with a BTK inhibitor had an ORR of 67%.
  • A study suggests that the globalization of cancer clinical trials may contribute to racial disparities in enrollment (Cancer 2021 Mar 8 [Epub ahead of print]). Researchers analyzed 49 international trials that led to 35 drug approvals by the FDA between 2015 and 2018. They found that, overall, Black patients accounted for only 2.5% of enrollment, and trials with more patients enrolled outside the United States had fewer Black participants.
  • Based on findings from the phase III CANOPY-2 trial, Novartis announced that adding the IL1β inhibitor canakinumab (ACZ885) to chemotherapy may not improve OS of patients with locally advanced or metastatic non–small cell lung cancer who have received treatment. Canakinumab will continue to be tested as a first-line and adjuvant therapy in the phase III CANOPY-1 and CANOPY-A trials.

February 26–March 4

  • Amgen announced it will acquire Five Prime Therapeutics for $1.9 billion. In the deal, Amgen will gain Five Prime’s anti-FGFR2b agent bemarituzumab (FPA144), which is in clinical testing for patients with advanced gastric cancer and FGFR2b mutations. In the phase II FIGHT trial, bemarituzumab plus chemotherapy led to longer overall and progression-free survival than chemotherapy alone.
  • The FDA approved the ALK inhibitor lorlatinib (Lorbrena; Pfizer) in patients newly diagnosed with metastatic non–small cell lung cancer (NSCLC) who have ALK mutations. The approval was based on the phase III CROWN trial, in which the agent reduced the risk of disease progression or death by 72% compared with crizotinib (Xalkori; Pfizer). The agency also converted lorlatinib’s 2018 accelerated approval for previously treated ALK-positive NSCLC into a full approval.
  • The FDA also granted accelerated approval to melphalan flufenamide (Pepaxto; Oncopeptides AB) plus dexamethasone in patients with relapsed/refractory multiple myeloma who have received at least four prior therapies. The decision was based on the phase II HORIZON trial, in which the drug elicited an overall response rate of 23.7%, and patients responded for a median of 4.2 months. The approval is the first for melphalan flufenamide, a peptide–drug conjugate.
  • Researchers reported that blinatumomab may be effective in children with high-risk relapsed B-cell acute lymphoblastic leukemia (JAMA 2020;325:843–54). In a phase III trial, 31% of patients treated with blinatumomab experienced relapse, death, or a second malignancy after a median of 22.4 months, compared with 57% of those who received consolidation chemotherapy. Blinatumomab is a bispecific antibody that targets CD3 and CD19.
  • An analysis revealed that the COVID-19 pandemic may be disrupting pediatric cancer care worldwide (Lancet Child Adolesc Health 2021 Mar 3 [Epub ahead of print]). Researchers surveyed pediatric oncology providers at 213 institutions in 79 countries between June 22 and August 21, 2020. Overall, 43% of centers reported a decrease in newly diagnosed pediatric cancers and 34% reported an increase in "treatment abandonment," defined as a failure to start treatment or a delay in care of 4 weeks or longer.
  • Merck announced it will stop U.S. marketing of pembrolizumab (Keytruda) for previously treated metastatic small cell lung cancer. The decision came after the agent failed to improve overall survival in the phase III KEYNOTE-604 trial. Previously, the FDA granted the PD-L1 inhibitor accelerated approval for this indication based on encouraging results in the early-phase KEYNOTE-158 and KEYNOTE-028 trials.

February 2020

February 19–25

  • The FDA approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo; Regeneron/Sanofi) as a first-line treatment for patients with advanced non–small cell lung cancer and high PD-L1 expression. The approval was based on the phase III EMPOWER-Lung 1 trial, in which patients treated with the agent had a median overall survival (OS) of 22.1 months and a median progression-free survival (PFS) of 6.2 months, compared with 14.3 months and 5.6 months, respectively, in patients who received chemotherapy.
  • Idecabtagene vicleucel (ide-cel/bb2121; Bluebird Bio/Celgene) may be effective in patients with relapsed/refractory multiple myeloma (N Engl J Med 2021 Feb 25 [Epub ahead of print]). In the phase II KarMMa trial, 128 patients had an overall response rate of 73% and a median PFS of 8.8 months. Idecabtagene vicleucel is an autologous chimeric antigen receptor T-cell therapy that targets B-cell maturation antigen.
  • The launch of a new foundation called Break Through Cancer was announced. The foundation will bring together cancer scientists at five institutions: The Koch Institute for Integrative Cancer Research at MIT in Cambridge, MA, the Dana-Farber Cancer Institute in Boston, MA, Memorial Sloan Kettering Cancer Center in New York, NY, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, MD, and The University of Texas MD Anderson Cancer Center in Houston. Multidisciplinary teams will conduct translational research on difficult-to-treat malignancies such as pancreatic cancer, ovarian cancer, glioblastoma, and acute myeloid leukemia.
  • AstraZeneca will stop marketing the PD-L1 inhibitor durvalumab (Imfinzi) for locally advanced or metastatic bladder cancer in the United States. The FDA previously granted the agent an accelerated approval based on encouraging results in the phase I/II Study 1108 trial. The agent has since failed to meet its primary endpoint of improving OS compared with standard chemotherapy in the phase III DANUBE trial, prompting the decision.
  • The Epidemiology of Young Lung Cancer study launched to investigate the underlying causes of lung cancer in patients diagnosed before age 40. Researchers aim to gather medical, environmental, demographic, and lifestyle data from 250 patients with early-onset lung cancer and use this information to identify potential risk factors. The effort is a collaboration between the Addario Lung Cancer Medical Institute and the GO2 Foundation for Lung Cancer.
  • "Once we beat COVID, we’re going to do everything we can to end cancer as we know it," President Joe Biden said during a speech he gave after a tour of one of Pfizer’s COVID-19 vaccine manufacturing sites. Biden added that the President’s Council of Advisors on Science and Technology and the Office of Science and Technology Policy are developing an “advanced research effort on cancer and other diseases.” While serving as vice president, Biden led the White House’s Cancer Moonshot initiative.

February 12–18

  • Lenvatinib (Lenvima; Eisai) plus pembrolizumab (Keytruda; Merck) or everolimus (Afinitor; Novartis) may be effective in patients with advanced renal cell carcinoma. In the phase III CLEAR trial, patients treated with the pembrolizumab combination had a median progression-free survival (PFS) of 23.9 months and an objective response rate of 71%, compared with 14.7 months and 53.5% in patients who received the everolimus combination, and 9.2 months and 36.1%, respectively, in those who received standard sunitinib (Sutent; Pfizer). Findings were presented at the 2021 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, held virtually February 11–13, and simultaneously published (N Engl J Med 2021 Feb 13 [Epub ahead of print]).
  • Also presented at ASCO GU and published concurrently, researchers reported that the Nectin4-directed antibody–drug conjugate enfortumab vedotin (Seattle Genetics/Astellas) may extend survival for patients with advanced urothelial carcinoma who have already received chemotherapy and a PD-1–PD-L1 inhibitor (N Engl J Med 2021 Feb 12 [Epub ahead of print]). In the phase III EV-301 trial, patients treated with the agent had a median overall survival (OS) of about 12.9 months and a median PFS of 5.6 months, compared with nearly 9 months and 3.7 months, respectively, in patients who received standard chemotherapy. /li>
  • The tyrosine kinase inhibitor cabozantinib (Cabometyx; Exelixis) may be superior to sunitinib in patients with metastatic papillary renal cell carcinoma, according to findings reported at ASCO GU and concurrently published (Lancet 2021;397:P695–703). In a phase II trial, cabozantinib led to a response rate of 23% and a median PFS of 9 months, compared with 4% and 5.6 months for sunitinib.
  • Regeneron/Sanofi’s PD-1 inhibitor cemiplimab-rwlc may improve survival for patients newly diagnosed with advanced non–small cell lung cancer and high PD-L1 expression (Lancet 2021;397:P592¬–604). In the phase III EMPOWER-Lung 1 trial, patients treated with the agent did not reach median OS and had a median PFS of 8.2 months, compared with 14.2 months and 5.7 months, respectively, in patients who received standard chemotherapy.
  • The FDA approved the CDK4/6 inhibitor trilaciclib (Cosela; G1 Therapeutics) to protect bone marrow function and reduce the risk of severe neutropenia in patients receiving chemotherapy for extensive-stage small cell lung cancer. The approval was based on pooled findings from three randomized trials in which 11.4% of patients treated with the agent developed severe neutropenia during chemotherapy, compared with 52.9% of patients who received a placebo.
  • U.S. cancer centers and organizations issued a letter urging the Biden administration to prioritize COVID-19 vaccines for patients with cancer and survivors of cancer. "There is mounting evidence that patients with cancer are at increased risk of severe illness and death if they are infected with the virus," the letter states, adding that certain cancer survivors also have a higher risk of infection and death. The document was signed by more than 130 organizations, including the American Association for Cancer Research and the European Society for Medical Oncology.
  • The Leukemia & Lymphoma Society (LLS) launched the LLS National Patient Registry to gather data on patients with blood cancer who have been vaccinated against COVID-19, as well as those who have tested positive for the virus. Researchers aim to understand how patients with hematologic malignancies respond to the vaccine based on their type of cancer and any treatment they are receiving. Patients can join at www.lls.org.

February 5–11

  • Adjuvant nivolumab may be effective in patients with muscle-invasive urothelial carcinoma, according to findings presented at the 2021 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, held virtually February 11–13. In the phase III CheckMate 274 trial, patients treated with the PD-1 inhibitor after surgery had a median disease-free survival of 21 months, compared with 10.9 months in patients who received a placebo.
  • Also at ASCO GU, researchers reported that a decrease in prostate-specific antigen (PSA) testing has led to an increase in metastatic disease at diagnosis. Investigators analyzed data on PSA screening and metastatic prostate cancer in each U.S. state between 2008 and 2016. They found that the average percentage of eligible men screened for PSA overall decreased from 61.8% to 50.5%, while the incidence of metastatic disease at diagnosis increased from 6.4 to 9 cases per 100,000 men—and bigger drops in PSA screening were associated with larger increases in metastatic prostate cancer diagnoses.
  • The FDA approved lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) in adults with relapsed/refractory large B-cell lymphoma who previously received at least two other therapies. The approval was based on the TRANSCEND NHL 001 trial, in which 192 patients had an overall response rate of 73% and a complete response rate of 54%. The approval is the first for lisocabtagene maraleucel, a chimeric antigen receptor T-cell therapy that targets CD19.
  • The FDA approved the PD-1 inhibitor cemiplimab-rwlc (Libtayo; Regeneron/Sanofi) in patients with locally advanced basal cell carcinoma who have already received a hedgehog pathway inhibitor (HHI), or who aren’t eligible for an HHI. The agency also granted accelerated approval to the drug for use in patients with metastatic disease. The approvals were based on Study 1620, in which patients with advanced disease had an objective response rate of 29%, and those with metastatic disease had an objective response rate of 21%.
  • The agency also granted accelerated approval to the PI3Kδ inhibitor umbralisib (Ukoniq; TG Therapeutics) in patients with relapsed/refractory marginal zone lymphoma (MZL) who received at least one prior anti-CD20 therapy, as well as in patients with relapsed/refractory follicular lymphoma (FL) who received at least three prior therapies. In the phase II UNITY-NHL trial, the agent elicited responses in 49% and 43% of patients with MZL and FL, respectively.
  • The FDA Oncologic Drugs Advisory Committee voted 10 to 0 against pembrolizumab (Keytruda; Merck) as a neoadjuvant therapy for high-risk triple-negative breast cancer. The committee concluded that the 7.5% improvement in pathologic complete response seen in the phase III KEYNOTE-522 trial is not large enough to indicate a clinical benefit, and more definitive findings are needed. The trial will continue to amass data on event-free survival and overall survival (OS).
  • AstraZeneca announced that durvalumab (Imfinzi) may not extend survival in patients with recurrent or metastatic head and neck squamous cell carcinoma and high PD-L1 expression. In the phase III KESTREL trial, the agent did not improve OS compared with standard chemotherapy. A PD-L1 inhibitor, durvalumab is FDA approved for certain forms of lung and bladder cancer.

January 29–February 4

  • At the American Association for Cancer Research (AACR) Virtual Meeting: COVID-19 and Cancer, held February 3–5, researchers reported that patients with lymphoma treated with B cell–depleting therapies may have poor outcomes if they develop severe COVID-19. Researchers evaluated 111 patients with lymphoma admitted to the hospital with severe COVID-19 infections, 63 of whom had received B cell–depleting therapies within the past year. These patients were almost twice as likely to stay in the hospital for more than 30 days than those who had received other therapies—and they were more than twice as likely to die.
  • Also at the AACR COVID-19 and Cancer meeting, researchers highlighted the financial burden of the COVID-19 pandemic on people who survive cancer. The team analyzed data from 10,760 U.S. adults during the pandemic, including 854 people who had been diagnosed with cancer. They found that 18% of cancer survivors experienced financial hardship during the pandemic; younger adults and those insured through Medicaid or living in rural areas were more likely to experience money troubles than those who had not been diagnosed with cancer.
  • A pair of papers revealed that fecal microbiota transplant (FMT) may improve immunotherapy responses in patients with melanoma. In one study, researchers transplanted fecal microbiota from seven immunotherapy responders to 16 patients with PD-1–refractory melanoma (Science 2021;6529:595–602). After transplant, six of the recipients responded to pembrolizumab (Keytruda; Merck). The second paper reported on a phase I trial in which three of 10 patients who had progressed on immunotherapy responded to a PD-1 inhibitor after FMT (Science 2021;6529:602–9).
  • People who survive cancer are more likely to have underlying medical conditions linked to severe COVID-19 than those in the general population (J Natl Cancer Inst 2021 Feb 3 [Epub ahead of print]). Researchers analyzed data from 6,411 people who had had cancer and 77,748 people without a history of cancer. They found that 56.4% of survivors had at least one medical condition associated with an increased risk of severe COVID-19, such as heart disease and diabetes, compared with 41.6% of people who hadn’t had cancer.
  • The FDA granted accelerated approval to tepotinib (Tepmetko; EMD Serono) in patients with metastatic non–small cell lung cancer with MET exon 14 skipping mutations. The approval was based on the phase II VISION trial, in which 69 newly diagnosed patients had an overall response rate (ORR) of 43% and a median duration of response (DoR) of 10.8 months; 83 patients who had received prior therapies had an ORR of 43% and a median DoR of 11.1 months.
  • The World Health Organization announced that breast cancer is now the most common form of cancer worldwide. In 2020, 2.3 million new cases of breast cancer were diagnosed, accounting for 11.7% of all cancer cases. Lung cancer—which had been the most common malignancy for the past two decades—is now second, followed by colorectal cancer.

January 2021

January 22–28

  • The KRASG12C inhibitor sotorasib (Amgen) may be effective in patients with previously treated non–small cell lung cancer (NSCLC), according to results presented at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer (WCLC), rescheduled from August and being held virtually January 28–31. In the phase II CodeBreak 100 trial, 124 patients had an objective response rate (ORR) of 37.1% and a median progression-free survival (PFS) of 6.8 months; responses lasted for a median of 10 months. Based on these data, Amgen filed for FDA approval of the drug in December 2020.
  • Also at the WCLC, researchers reported that amivantamab (Janssen) may be an effective therapy for patients with metastatic or inoperable NSCLC and EGFR exon 20 insertions who have already received chemotherapy. In the phase I CHRYSALIS trial, 40% of 81 patients responded; they had a median PFS of 8.3 months and a median overall survival (OS) of 22.8 months. Amivantamab is a bispecific antibody that targets EGFR and MET.
  • Datopotamab deruxtecan (AstraZeneca/Daiichi Sankyo) may be active in patients with advanced or metastatic NSCLC, researchers reported at the WCLC. In the phase I TROPION-PanTumor01 trial, 159 patients had ORRs ranging from 21% to 25%, depending on the dose; disease control rates ranged from 67% to 80%, and median PFS was 4.3 to 8.2 months. Datopotamab deruxtecan is an antibody–drug conjugate that consists of a TROP2-directed monoclonal antibody linked to a topoisomerase 1 inhibitor derived from exatecan.
  • Bristol Myers Squibb announced that the FDA approved nivolumab (Opdivo) plus cabozantinib (Cabometyx; Exelixis) for advanced renal cell carcinoma. The approval was based on the phase III CHECKMATE-9ER trial, in which newly diagnosed patients treated with the combination had a median PFS of 16.6 months and an overall response rate of 55.7%, compared with 8.3 months and 27.1%, respectively, in patients who received nivolumab, a PD-1 inhibitor, plus sunitinib (Sutent; Pfizer).
  • The American Lung Association released its 19th annual State of Tobacco Control report. The publication calls for ending sales of flavored tobacco products to reduce their use among kids as well as in Black communities. The report also highlights the increased need to prioritize smoking cessation during the COVID-19 pandemic, noting that smoking raises the risk of severe infection.
  • The National Comprehensive Cancer Network (NCCN) published guidelines on administering COVID-19 vaccines to patients with cancer. The document recommends vaccinating all patients undergoing active cancer treatment as soon as possible. It also offers suggestions for prioritizing patients for vaccines, scheduling inoculations around immunosuppressive therapy, and handling drug interactions or side effects, among other things.
  • U.S. cancer centers and organizations issued a public letter urging the resumption of cancer screening and treatment during the COVID-19 pandemic. The letter, which was written by the NCCN and the American Cancer Society, and signed by 76 other organizations, highlights considerable drops in cancer screening and diagnosis—as well as delays in treatment—during the pandemic.
  • President Joe Biden nominated Eric Lander, PhD, to serve as his science advisor and director of the Office of Science and Technology Policy, and Rochelle Walensky, MD, MPH, to lead the Centers for Disease Control and Prevention. Biden also appointed Janet Woodcock, MD, as acting commissioner of the FDA. Lander heads the Broad Institute of MIT and Harvard in Cambridge, MA, and Walensky is chief of the Infectious Diseases Division at Massachusetts General Hospital in Boston; Woodcock served as director of the FDA’s Center for Drug Evaluation and Research.

January 15–21

  • During the American Society of Clinical Oncology (ASCO) 2021 Gastrointestinal (GI) Cancers Symposium, held virtually January 15–17, researchers reported that adding bemarituzumab (FPA144; Five Prime) to chemotherapy may improve survival for patients with advanced gastric cancer and FGFR2b mutations. In the phase II FIGHT trial, patients treated with the combination had a median progression-free survival (PFS) of 9.5 months and did not reach median overall survival (OS), compared with 7.4 months and 12.9 months, respectively, in patients who received chemotherapy alone. Bemarituzumab is a targeted antibody that inhibits FBFR2b.
  • The investigational CD73 inhibitor AB680 (Arcus Biosciences) combined with nab-paclitaxel (Abraxane; Celgene) plus gemcitabine and zimberelimab (AB122; Arcus) may be effective in patients newly diagnosed with metastatic pancreatic cancer, researchers reported at the ASCO GI meeting. In a phase I trial, seven of 17 patients responded to the combination, and eight others experienced some tumor shrinkage.
  • The FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who previously received trastuzumab (Herceptin; Genentech). The approval was based on the phase II DESTINY-Gastric01 trial, in which patients treated with the agent had a median OS of 12.5 months, compared with 8.4 months in patients who received chemotherapy. Fam-trastuzumab deruxtecan-nxki consists of the anti-HER2 monoclonal antibody trastuzumab connected to deruxtecan, a topoisomerase I inhibitor.
  • The Community Oncology Alliance requested that community oncologists be given priority approval to administer COVID-19 vaccinations to their patients with cancer and blood disorders who are immunocompromised. The request, which was made to state governors and the U.S. government, also asked that oncologists be provided with enough vaccines to complete the inoculations.
  • Black women in the United States may be at greater risk of breast cancer recurrence than white women, according to findings in JAMA Oncology. Researchers analyzed Oncotype DX Breast Recurrence Score tests from 86,033 women with breast cancer. They found that Black women were significantly more likely than white women to have a recurrence score greater than 25; moreover, Black women were more likely to die from breast cancer than white women with comparable recurrence risk. They also discovered that the prognostic accuracy of the recurrence score was significantly lower in Black women than white women, highlighting the need to calibrate such tests in more diverse populations.
  • GlaxoSmithKline reported that bintrafusp alfa (M7824) may not be effective at treating non–small cell lung cancer that expresses PD-L1. In the phase III INTR@PID Lung 037 trial, the drug did not improve PFS compared with the PD-1 inhibitor pembrolizumab (Keytruda; Merck), leading an independent data monitoring committee to recommend discontinuing the trial. A bifunctional immunotherapy that blocks TGFβ and PD-L1, bintrafusp alfa will continue testing in other trials.

January 8–14

  • Sanofi announced it will acquire Kymab for $1.1 billion up front and up to $350 million more in milestone payments. Sanofi will gain KY1044, an anti-ICOS antibody that is being tested alone and in combination with a PD-L1 inhibitor in solid cancers. Sanofi’s purchase also includes Kymab’s leading candidate KY1005, an anti-OX40L antibody being assessed for various immune disorders.
  • Novartis will pay BeiGene $650 million up front and as much as $1.55 billion in milestone payments for the PD-1 inhibitor tislelizumab. Novartis will acquire rights to develop, manufacture, and commercialize the drug in North America, Japan, the European Union, and six other European countries. Tislelizumab is approved in China for certain forms of classic Hodgkin lymphoma, urothelial carcinoma, and non–small cell lung cancer (NSCLC).
  • The American Cancer Society (ACS) reported that the cancer mortality rate decreased by 2.4% from 2017 to 2018 in the United States, the biggest single-year drop on record. The ACS estimated that there will be 1.9 million new cancer diagnoses and 600,000 cancer-related deaths in 2021. However, the projections don’t account for the COVID-19 pandemic, which has disrupted cancer screenings and care.
  • In The New England Journal of Medicine, a report revealed the distribution of KRASG12C mutations by race and sex. Researchers analyzed the prevalence of KRASG12C mutations in 32,138 patients with cancer, 13.8% of whom had NSCLC. They found that among patients with NSCLC, KRASG12C mutations occurred in 13% of white, 10.9% of Black, and 3.6% of Asian patients. This mutation was significantly more common in white and Asian women with NSCLC than their male counterparts.
  • The FDA approved crizotinib (Xalkori; Pfizer) in children and young adults with relapsed/refractory, systemic anaplastic large cell lymphoma who have ALK mutations. The approval was based on a phase I/II trial in which 26 patients had an objective response rate of 88% and a complete remission rate of 81%. An ALK inhibitor, crizotinib was previously approved for patients with NSCLC who have ALK or ROS1 mutations.
  • The FDA placed a clinical hold on Neoleukin Therapeutics’ phase I trial of NL-201. The agency asked Neoleukin to develop a new assay that more precisely measures dosing of the drug. NL-201 is a protein therapeutic that stimulates IL2 and IL15 signaling.
  • U.S. Customs and Border Protection and the FDA announced the seizure of counterfeit, unauthorized electronic cigarette (e-cigarette) cartridges. In January, a shipment of 33,681 cartridges was discovered at the Dallas Fort Worth International Airport in Texas. In December, the agencies seized 42 shipments of e-cigarette cartridges from China en route to several Texas counties. In both instances, the shipments included flavored cartridges that are illegal in the United States.

December 29–January 7

  • In The New England Journal of Medicine, a paper documented two instances of vaginal cancer transmission from mother to infant. Next-generation sequencing revealed that a 2-year-old and a 6-year-old boy with lung cancer developed the malignancies from uterine cervical tumors that were transferred from their mothers during childbirth. In each case, the child’s tumor lacked a Y chromosome, and shared somatic mutations, a human papillomavirus genome, and single-nucleotide polymorphism alleles with the mother’s tumor.
  • After consulting with the FDA, Bristol Myers Squibb withdrew nivolumab (Opdivo) from the U.S. market for patients with small cell lung cancer who had received prior therapies. The decision was based on the phase III CheckMate-451 and CheckMate-331 trials, in which the PD-1 inhibitor did not improve overall survival (OS) compared with standard therapies. The FDA had granted nivolumab an accelerated approval in August 2018 based on promising results in the phase I/II CheckMate-032 trial.
  • Adding bevacizumab (Avastin; Genentech) to osimertinib (Tagrisso; AstraZeneca) may not improve the latter’s efficacy in patients with EGFR-mutant non–small cell lung cancer (NSCLC), researchers reported in JAMA Oncology. In a phase II trial, the combination did not increase progression-free survival (PFS) or OS compared with osimertinib alone. Researchers had hypothesized that bevacizumab, an angiogenesis inhibitor, might amplify the effects of osimertinib, a tyrosine kinase inhibitor.
  • Calithera announced that its glutaminase inhibitor telaglenastat plus cabozantinib (Cabometyx; Exelixis) may not be effective in advanced or metastatic renal cell carcinoma. In the phase II CANTATA trial, the combination did not improve PFS compared with cabozantinib alone. Given the negative results, the company will cut its workforce by approximately 35%, although testing will continue in NSCLC.
  • Eprenetapopt (APR-246; Aprea Therapeutics) plus azacitidine failed to improve outcomes in patients with TP53-mutant myelodysplastic syndromes. In a phase III trial, the combination did not significantly increase the complete remission rate compared with azacitidine alone, although the company will continue to analyze the data as it matures. Eprenetapopt is a small molecule that reactivates mutant TP53.
  • Men of African ancestry may be at higher risk of developing prostate cancer than those of European ancestry, according to findings in Nature Genetics. Researchers conducted a meta-analysis of prostate cancer studies that included 107,247 patients and 127,006 control subjects. They identified 86 new genetic risk variants associated with the disease and determined that men of African descent had a risk score that was 2.18 times higher on average than that of men with European backgrounds.

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