KEYNOTE-010 is a global, open-label, randomized, pivotal Phase 2/3 study evaluating two doses of Keytruda (FDA-approved 2mg/kg dose or investigational 10 mg/kg dose every three weeks) compared to docetaxel (75mg/m2 every 3 weeks) in 1,034 patients with NSCLC who experienced disease progression after platinum-containing therapy and whose tumors had programmed death ligand-1 (PD-L1) expression tumor proportion scores (TPS) of ≥1%. The primary endpoints were overall survival (OS) and superior progression-free survival (PFS). Outcomes were assessed in patients whose tumors were strongly PD-L1 positive (defined as TPS of ≥50%), and in all PD-L1 positive patients. Tumor response was assessed at week 12, then every 6 weeks thereafter per RECIST 1.1 criteria by independent, central, blinded, radiographic review and investigator-assessed, immune-related response criteria.
Data from KEYNOTE-010 showed that treatment with Keytruda at both doses was associated with longer OS compared with docetaxel treatment in all PD-L1 positive patients. Keytruda also provided superior PFS compared to docetaxel in patients whose tumors had TPS ≥50%. However, Keytruda treatment at both doses showed numerically but not statistically superior PFS vs. docetaxel in all PD-L1 positive patients.
Keytruda is currently indicated at a dose of 2mg/kg every three weeks for the treatment of patients with metastatic NSCLC with disease progression on or after platinum-containing chemotherapy whose tumors express PD-L1, and for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
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