Core Insights - Bicara Therapeutics announced early data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa in combination with pembrolizumab for first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] - The results indicate a high overall response rate and a safety profile consistent with the 1500mg dose, supporting ongoing pivotal trials [1][2] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa as its lead program [11] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β) [9][11] Clinical Trial Data - In the efficacy evaluable population of 30 patients, the objective response rate was 57%, with 50% achieving partial responses and 7% achieving complete responses [6] - The disease control rate was reported at 83%, and complete neutralization of TGF-β1 was observed [6] - Safety findings were consistent with the known safety profile of ficerafusp alfa plus pembrolizumab in R/M HNSCC [6] Upcoming Events - Bicara Therapeutics will present the findings at the European Society for Medical Oncology (ESMO) Asia Congress on December 6, 2025, and will host a conference call and webcast on the same day [1][5][3]
Bicara Therapeutics Announces Publication of an Abstract with Preliminary Phase 1b Expansion Cohort Data Evaluating 750mg of Ficerafusp Alfa Weekly Plus Pembrolizumab in 1L HPV-negative R/M HNSCC at ESMO Asia 2025