Core Insights - Bicara Therapeutics Inc. has initiated the enrollment of patients in the FORTIFI-HN01 trial, a pivotal Phase 2/3 study evaluating ficerafusp alfa in combination with pembrolizumab for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] - Ficerafusp alfa is a first-in-class bifunctional antibody targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β), aiming to provide a novel treatment option for patients with advanced HNSCC [2][5] 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 [6][7] - The company aims to address significant unmet medical needs in oncology, particularly in HNSCC, where current treatment options are limited [2][4] Industry Context - HNSCC is a prevalent cancer type with increasing incidence, projected to reach one million new cases globally by 2030, highlighting the urgent need for innovative therapies [3] - Approximately 80% of patients with recurrent/metastatic HNSCC are HPV-negative, facing severe morbidities and low survival rates, which underscores the critical demand for effective treatment options [4][3] Trial Details - The FORTIFI-HN01 trial is designed as a global, randomized, double-blinded, placebo-controlled study aiming to enroll around 650 patients with recurrent/metastatic HNSCC, focusing on those with a PD-L1 CPS of 1 or higher [2] - Primary endpoints include overall response rate and overall survival, with potential implications for regulatory filings for accelerated and full approval [2]
Bicara Therapeutics Announces First Patients Enrolled in FORTIFI-HN01, a Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma