Keytruda has secured another key approval after the anti-PD-1 therapy was approved in China in combination with carboplatin and paclitaxel for first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).
This new indication was granted full approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-407 trial, including interim data from an extension of the global study in Chinese patients.
With this third first-line approval in NSCLC in less than one year, Merck’s Keytruda is now the first anti-PD-1 therapy approved in China in combination with chemotherapy for the first-line treatment of squamous and nonsquamous NSCLC, as well as in the monotherapy setting for appropriate patients with NSCLC.
“In KEYNOTE-407, Keytruda in combination with chemotherapy significantly improved both overall survival and progression-free survival in patients with metastatic squamous non-small cell lung cancer,” said Prof. Ying Cheng, director of Jilin Cancer Hospital.
“Lung cancer is the leading cause of cancer death in China, so this approval represents an important milestone for the patients and families facing this difficult-to-treat disease.”