Bicara Therapeutics presented Phase 1b data showing that 750mg of ficerafusp alfa in combination with pembrolizumab has a consistent overall response rate and safety profile compared to the 1500mg dose. The deeper tumor responses seen with the higher dose are expected to lead to more durable outcomes for patients. The optimal dose for the pivotal FORTIFI-HN01 study is anticipated to be declared in Q1 2026. The company will host a conference call and webcast today at 9:00 a.m. ET to discuss the data and findings.

The data presented at the ESMO Asia Congress showed that the 750mg dose had a 57% confirmed overall response rate, with 10% complete responses and 29% demonstrating deep responses. Biomarker data showed that the 1500mg dose had greater TGF-β inhibition and immune activation, leading to deeper clinical responses at 24 weeks. The company plans to announce the optimal biologic dose for the pivotal study in early 2026.

Head and neck squamous cell carcinoma (HNSCC) is a common cancer with a rising incidence. Most cases are HPV-negative and associated with severe symptoms. Ficerafusp alfa is a bifunctional antibody designed to penetrate tumors and drive deep responses. The FDA has granted Breakthrough Therapy Designation for its use in HNSCC. The Phase 2/3 FORTIFI-HN01 trial is ongoing to evaluate its efficacy.

Read more at GlobeNewswire: Bicara Therapeutics’ Preliminary Phase 1b Expansion Cohort