Reported Saturday, Bicara Therapeutics Reports 57% Confirmed Overall Response Rate With 750mg Ficerafusp Alfa Weekly Plus Pembrolizumab, Supporting Pivotal Interim Analysis

Benzinga·12/08/2025 09:34:59

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Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates consistent overall response rate and safety profile comparable to 1500mg QW dose, further derisking pivotal FORTIFI-HN01 study interim analysis
Totality of data demonstrates that greater TGF-β inhibition, observed at 1500mg of ficerafusp alfa, drives deeper tumor responses that translate to more durable outcomes for patients
Pivotal FORTIFI-HN01 optimal dose declaration expected in first quarter 2026