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Noted This Week - Archive 2021

Noted This Week - 2021 Archive

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

February 2020

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]).
  • 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.

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  • 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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