Merck’s KEYTRUDA approved in China for treatment of NSCLC

Merck announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations. This new indication was granted conditional approval based on overall survival and progression-free survival data from the pivotal Phase 3 KEYNOTE-189 trial in patients regardless of PD-L1 tumor expression status. Continued approval may be contingent upon verification and description of clinical benefit in Chinese patients in a confirmatory trial. With this approval, KEYTRUDA is the first anti-PD-1 therapy approved for more than one tumor type in China, following its initial approval in July 2018 for advanced melanoma, and the first anti-PD-1 therapy approved in the first-line treatment setting for metastatic nonsquamous NSCLC.

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