Merck Announces KEYTRUDA (pembrolizumab) Met Primary Endpoint of Overall Survival (OS) in Patients with Advanced Hepatocellular Carcinoma Previously Treated with Sorafenib
Pembrolizumab (KEYTRUDA) significantly improved overall survival versus placebo in Asian patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE‑394 Phase 3 trial).
In the Phase 3 KEYNOTE‑394 trial, pembrolizumab plus best supportive care was compared with placebo plus best supportive care in 453 Asian patients with advanced hepatocellular carcinoma previously treated with sorafenib or oxaliplatin chemotherapy. The trial met its primary endpoint of overall survival (OS), demonstrating a statistically significant improvement in OS for pembrolizumab versus placebo. Secondary endpoints, including progression‑free survival (PFS) and objective response rate (ORR), also improved with pembrolizumab and were statistically significant.
Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths worldwide, often diagnosed at an advanced stage with poor prognosis. The study provides confirmatory evidence of clinical benefit for pembrolizumab as a second‑line therapy after sorafenib, supporting its accelerated approval and informing treatment guidelines for patients with limited therapeutic options.
Evidence level: Állatkísérletes. Állatmodellben vizsgálták.
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