Noted This Week


September 13–19

For the first time, the FDA, the Australian Therapeutic Goods Administration, and Health Canada simultaneously reviewed a cancer drug, granting an accelerated approval to pembrolizumab (Keytruda; Merck) plus lenvatinib (Lenvima; Eisai) in certain patients with advanced endometrial carcinoma. The review was conducted through Project Orbis, an initiative of the FDA Oncology Center of Excellence. The approval was based on the phase III KEYNOTE-146 trial, in which 38 previously treated patients with tumors that were not microsatellite instability–high or mismatch repair–deficient had an objective response rate of 38.3%.

The FDA issued a warning that certain CDK4/6 inhibitors can cause rare but serious lung inflammation. The warning applies to palbociclib (Ibrance; Pfizer), ribociclib (Kisqali; Novartis), and abemaciclib (Verzenio; Eli Lilly), which are approved for HR-positive, HER2-negative breast cancer. The FDA notes that the drugs’ benefits are still greater than the risks when they are used as prescribed.

The agency also approved the antiandrogen apalutamide (Erleada; Janssen) for patients with metastatic, castration-sensitive prostate cancer. The approval was based on the phase III TITAN trial, in which patients treated with the drug plus androgen-deprivation therapy had a 2-year overall survival rate of 82.4% and a 2-year radiographic progression-free survival rate of 68.2%, compared with 73.5% and 47.5%, respectively, in patients who received a placebo plus androgen-deprivation therapy.

Radiotherapy may reduce the risk of cytokine release syndrome in patients with non-Hodgkin lymphoma treated with chimeric antigen receptor (CAR) T-cell therapies, according to findings presented at the American Society for Radiation of Oncology Annual Meeting in Chicago, IL. In the study, none of five patients who received radiotherapy in the month before CAR T-cell infusion and one of seven patients who received earlier radiotherapy experienced grade 3 or higher cytokine release syndrome, compared with five of 19 patients who did not receive radiotherapy.

The FDA placed a clinical hold on Amgen’s phase I trial testing the MCL1 inhibitor AMG 397 in multiple myeloma, non-Hodgkin lymphoma, and acute myeloid leukemia. During the hold, the company will evaluate the risk of cardiac toxicity. Amgen also halted a phase I trial of another MCL1 inhibitor, AMG 176.

Janssen announced that the anti-CD38 therapy daratumumab (Darzalex) plus bortezomib (Velcade; Takeda), lenalidomide (Revlimid; Celgene), and dexamethasone may improve responses in patients with multiple myeloma who are eligible for an autologous stem-cell transplant. In the phase II GRIFFIN trial, patients treated with the combination had a stringent complete response rate of 42% and a minimal residual disease rate of 59%, compared with 32% and 24%, respectively, in patients who received bortezomib, lenalidomide, and dexamethasone alone.

Carcinogenic chemicals in U.S. drinking water could cause 100,000 lifetime cases of cancer, according to a report by the Environmental Working Group. Researchers analyzed 22 contaminants in 48,000 water systems between 2010 to 2017 and found that the national risk of cancer is two orders of magnitude higher than what would be considered insignificant. Most of the risk can be attributed to arsenic, by-products of disinfectants, and radioactive chemicals.

The American Association for Cancer Research (AACR) released its 2019 Cancer Progress Report, available at http://cancerprogressreport.org. The report includes the latest information on cancer survival, diagnosis, prevention, and treatment. The AACR also led the seventh annual Rally for Medical Research Hill Day, joining more than 300 other organizations to advocate for robust, sustained, and predictable annual funding increases for the NIH.


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