Merck withdraws MAA for Keytruda combo in metastatic NSCLC

Merck & Co. Inc. (NYSE:MRK) said it is withdrawing its MAA for anti-PD-1 antibody Keytruda as first-line treatment in combination with Alimta pemetrexed and carboplatin to treat metastatic non-squamous non-small cell lung cancer (NSCLC). The application was based on results from Cohort G of the Phase II KEYNOTE-021 trial. Data announced in September from the study in patients with previously untreated NSCLC showed that first-line treatment with Keytruda plus Alimta and carboplatin continued to improve progression-free survival (PFS) and overall response rate (ORR) with an additional 5 months of follow-up. However, median overall survival (OS) had not yet been reached in the Keytruda arm (see BioCentury, Sept. 22).

Merck spokesperson Pamela Eisele told BioCentury the company withdrew the application "based on discussions with the European regulatory authorities" but declined to elaborate further. Eisele said Merck plans to submit a new application once additional data is available from ongoing studies, including the Phase III KEYNOTE-189 trial. That study is evaluating Keytruda plus platinum chemotherapy in 570 patients with first-line, metastatic, non-squamous NSCLC...