Merck announces NMPA approved Keytruda combination in China
Merck announced that KEYTRUDA, Merck's anti-PD-1 therapy, has been approved by the National Medical Products Administration, or NMPA, in China in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer, or NSCLC. This new indication was granted full approval based on overall survival, or 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, 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, data from a pre-specified interim analysis showed that KEYTRUDA in combination with chemotherapy resulted in a statistically significant improvement in OS and progression-free survival, the dual primary endpoints, compared to chemotherapy alone.