October 11, 2019
- Merck has announced that the China NMPA (National Medical Products Administration) has approved the use of Keytruda (pembrolizumab) as a frontline monotherapy agent in patients with locally advanced or metastatic NSCLC tumors with PD-L1 expression of at least 1% (TPS ≥1%, determined by an NMPA-approved test), without EGFR or ALK genomic mutations.
- The approval is based on data from Chinese patients in the global Phase 3 KEYNOTE-042 trial (NCT02220894) and a separate China extension study (NCT03850444).
- Patients with PD-L1 expression ≥1% treated with Keytruda (n=128) vs. platinum-based chemotherapy (n=134) showed mOS = 20.0 months vs. 13.7 months.
- Results from the China extension study were presented at the IASLC World Conference on Lung Cancer in September 2019 (abstract MA11.02).