The NMPA approval is based on the P-III KEYNOTE-042 study assessing Keytruda as monothx. vs CT in patients with stage III NSCLC who were not candidates for surgical resection/definitive chemoradiation/mNSCLC with PD-L1 expression & no prior systemic treatment for mNSCLC including data from the extension of KEYNOTE-042 in Chinese patients
The extension study results demonstrated improvement in OS in patients whose tumors expressed PD-L1 with a TPS ≥50%- TPS ≥20% and in the entire study population with a TPS ≥1%
KEYTRUDA is an anti-PD-1 therapy- act blocking the interaction between PD-1 and its ligands- PD-L1 and PD-L2 thus activating T lymphocytes affecting both tumor and healthy cells and is the first anti-PD-1 therapy to be approved as both monothx. & in combination with CT as 1L treatment for NSCLC in China
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Ref: Merck | Image: Merck
