Merck withdraws Keytruda indication for metastatic small cell lung cancer
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Merck voluntarily withdrew pembrolizumab’s indication in the United States for treatment of certain patients with metastatic small cell lung cancer.
The indication applied to use of pembrolizumab (Keytruda, Merck) — an anti-PD-1 antibody — by patients whose disease progressed on or after platinum-based chemotherapy and at least one other prior line of therapy.
The company made the decision in consultation with the FDA after a confirmatory phase 3 trial of pembrolizumab for this indication failed to meet one of its dual primary endpoints.
The FDA granted accelerated approval to pembrolizumab for the small cell lung cancer indication in June 2019 based on response rate and response duration data from specific cohorts in the KEYNOTE-158 and KEYNOTE-028 trials.
Continued approval was contingent on confirmation of an OS benefit with pembrolizumab.
In January 2020, Merck announced the confirmatory phase 3 KEYNOTE-604 trial met one of its dual primary endpoints — showing a PFS improvement with pembrolizumab — but failed to meet its other endpoint of improved OS.
“The accelerated pathways created by the FDA have been integral to the remarkable progress in oncology care over the past 5 years and have helped many [patients with advanced cancer], including small cell lung cancer, access new treatments,” Roy Baynes, MD, PhD, chief medical officer, senior vice president and head of global clinical development for Merck Research Laboratories, said in a company-issued press release. “Keytruda remains a foundational treatment for certain patients with metastatic non-small cell lung cancer. We will continue to rigorously evaluate the benefits of Keytruda in small cell lung cancer and other types of cancer.”
Merck’s decision does not affect other indications for pembrolizumab. The agent is approved in the United States for specific patients with non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, triple-negative breast cancer, classical Hodgkin lymphoma, esophageal cancer, cervical cancer, hepatocellular carcinoma, renal cell carcinoma and several other malignancies.
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