September 25, 2018—(BRONX, NY)—When lung cancer has spread, or metastasized, to other parts of the body, standard chemotherapy offers only a modest survival benefit. Now, in a major advance described in today’s issue of the New England Journal of Medicine, an international team, including researchers from Albert Einstein College of Medicine and Montefiore Health System, report that combining chemotherapy with the immunotherapy drug Keytruda extends the lives of people with metastatic squamous non-small cell lung cancer (NSCLC) by more than 40 percent compared with chemotherapy alone—a significant improvement that should immediately change the standard of care.
“Immunotherapy is revolutionizing cancer care and this study is further evidence of its power,” said Balazs Halmos, M.D., M.S., coauthor on the paper and director of the multidisciplinary thoracic oncology program at the Montefiore Einstein Center for Cancer Care and director of clinical cancer genomics at the NCI-designated Albert Einstein Cancer Center. “Considering that responses in a fraction of these patients have been durable and lasting, we have reason to believe that immunotherapies may one day offer the promise of a cure for some people with metastatic lung cancer.”
NSCLC is the most common type of lung cancer, accounting for 85 percent of all cases. There are two main types: squamous and non-squamous NSCLC. This double-blind, randomized controlled trial enrolled 559 patients with metastatic squamous NSCLC. Approximately half the patients were treated with standard chemotherapy involving two chemotherapy drugs plus placebo (the control group) and the other half received two chemotherapy drugs plus Keytruda.
Compared with chemotherapy alone, adding Keytruda to standard chemotherapy improved patients’ median overall survival by 4.6 months (15.9 months vs. 11.3 months, or a 40.7 percent improvement) and extended by 1.6 months the time during which the disease did not progress (6.4 months vs. 4.8 months, or a 33 percent extension).
A study published this May by the same international collaboration led the U.S. Food and Drug Administration to approve the Keytruda-chemotherapy combination for patients with metastatic non-squamous NSCLC just last month. Dr. Halmos predicts that this new study will lead to the combination’s approval for metastatic squamous NSCLC as well.
“The pace of discovery in the field of immunotherapy is astonishing,” said Dr. Halmos. “Montefiore/Einstein’s involvement in cancer clinical trials gives our patients access to the latest advances in treatment.”
Dr. Halmos also led a sub-study of the trial described in The New England Journal of Medicine. He presented the data in an oral presentation, “Choice of taxane and outcomes in the KEYNOTE-407 study of pembrolizumab plus chemotherapy for metastatic squamous NSCLC,” at the World Conference on Lung Cancer this month. He and other investigators compared the two chemotherapy regimens offered in the main trial with respect to prolonging survival or extending the period without disease-progression. The two chemo regimens were equally effective with regard to both measures.
The study was funded by Merck & Co., Inc., the maker of Keytruda.