FDA Grants Priority Review to Supplemental Biologics License Application for Pembrolizumab in NSCLC
Posted: Monday, May 7, 2018
On April 30, 2018, the U.S. Food and Drug Administration (FDA) accepted Merck’s supplemental Biologics License Application for pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC). If approved by the FDA, this would mark the third indication for pembrolizumab in metastatic NSCLC in the United States.
The supplemental application is based on data from the phase III KEYNOTE-189 trial, which were recently presented at the American Association of Cancer Research (AACR) 2018 Annual Meeting and published simultaneously in The New England Journal of Medicine. A total of 616 patients with metastatic nonsquamous NSCLC without sensitizing EGFR or ALK mutations who had received no previous treatment for metastatic disease were randomized to receive pemetrexed and a platinum-based drug plus pembrolizumab or placebo, followed by pembrolizumab or placebo plus pemetrexed maintenance therapy.
After a median follow-up of 10.5 months, the estimated rate of overall survival at 12 months was 69.2% in the pembrolizumab-combination group versus 49.4% in the placebo-combination group. Median progression-free survival was 8.8 months in the pembrolizumab-combination group and 4.9 months in the placebo-combination group. Adverse events of grade 3 or higher occurred in 67.2% of the patients in the pembrolizumab-combination group and in 65.8% of those in the placebo-combination group.