In a major advance, 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%. 

The results have been described in the latest issue of New England Journal of Medicine. When lung cancer has spread, or metastasized, to other parts of the body, standard chemotherapy offers only a modest survival benefit.

“Immunotherapy is revolutionizing cancer care and this study is further evidence of its power,” said Balazs Halmos, MD, MS, 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% 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% 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% extension).

A study published this May, by the same international collaboration, led the US 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 substudy 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.