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FDA Approves Frontline Pembrolizumab Combo for NSCLC

Jason M. Broderick @jasoncology
Published: Wednesday, May 10, 2017

The FDA has granted an accelerated approval to pembrolizumab (Keytruda) for use in combination with pemetrexed plus carboplatin as a frontline treatment for patients with metastatic or advanced nonsquamous non–small cell lung cancer (NSCLC), regardless of PD-L1 expression.

A phase III study is currently exploring platinum-based chemotherapy plus pemetrexed with or without pembrolizumab for patients with untreated squamous NSCLC. In this study, investigators will be able to pick between cisplatin or carboplatin as their platinum-based chemotherapy of choice. The primary endpoint of the study is PFS, with an accrual goal of 570 patients and an estimated completion date of March 2019 (NCT02578680).
Langer CJ, Gadgeel SM, Borghaei H, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016;17(11):1497-1508.

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