Dr. Gandhi on Pembrolizumab/Chemo Findings in NSCLC and FDA Approval

Leena Gandhi, MD, PhD, associate professor, Department of Medicine, director, Thoracic Medical Oncology Program, discusses the findings of cohort G of the KEYNOTE-021 trial that explored the combination of pembrolizumab (Keytruda) with carboplatin and pemetrexed for patients with advanced nonsquamous non-small cell lung cancer (NSCLC).

KEYNOTE-021 was initially a phase I study with a phase II expansion phase, Gandhi explains. In the phase II portion, 123 patients were randomized 1:1 to receive pembrolizumab plus first-line chemotherapy and half of whom had carboplatin/pemetrexed alone. The study, which was presented in 2016, showed that there was a progression-free survival benefit in those who received the immunotherapy/combination approval. However, there was not a benefit seen for overall survival with this novel regimen.

Based on these data, the FDA approved the regimen of pembrolizumab and carboplatin/pemetrexed in the first-line setting for these patients. The field is eagerly awaiting the data from the phase III study, adds Gandhi.