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

Leena Gandhi, MD, PhD
Published: Tuesday, Jun 20, 2017



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.


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.



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