The U.S. FDA has approved Merck’s Keytruda for the treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent adjuvant treatment after surgery.
The approval was based on data from the phase 3 KEYNOTE-671 trial evaluating the blockbuster anti-PD-1 therapy in combination with chemotherapy for patients with resectable stage II, IIIA or IIIB NSCLC. In the study, the Keytruda regimen demonstrated statistically significant improvements in event-free survival and overall survival, the study’s dual primary endpoints.
The approval was heralded as a milestone with the potential to change the current treatment paradigm for resectable non-small cell lung cancer, allowing for a continuous immunotherapy treatment regimen both before and after surgery.
Keytruda, now the top-selling drug in the world, was first approved in 2014 for advanced melanoma. The most recent approval marks Keytruda's sixth indication in NSCLC.
Last month, BMS shared the results from an interim analysis of a phase 3 NSCLC trial that found that combining the drugmaker's PD-1 immune checkpoint inhibitor, Opdivo, with chemotherapy before surgery — followed by adjuvant Opdivo post-surgery — led to a statistically significant improvement in event-free survival when compared to chemotherapy with a placebo pre-surgery followed by adjuvant placebo post-surgery.
