Core Viewpoint - Bicara Therapeutics Inc. announced updated interim data from its Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab for patients with recurrent/metastatic head and neck squamous cell carcinoma, highlighting promising efficacy and safety results [1][2][4]. 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 [10]. - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β) [8][10]. Clinical Trial Details - The Phase 1/1b trial evaluated ficerafusp alfa in patients with first line recurrent/metastatic head and neck squamous cell carcinoma, specifically those with a PD-L1 combined positive score (CPS) of ≥1 [4]. - Updated interim data showed a 64% objective response rate in the HPV-negative population, with 21% achieving a complete response [4]. - Median progression-free survival was reported at 9.8 months, and the 12-month overall survival rate was 61% [4]. Presentation and Data Sharing - Bicara Therapeutics will present the full dataset during an oral presentation at the 2025 ASCO Annual Meeting, scheduled for June 1, 2025 [1][3][4]. - The conference call will provide further insights into the overall survival and duration of response data following the ASCO presentation [1][5]. Industry Context - Head and neck squamous cell carcinoma (HNSCC) is a common malignancy with a rising incidence, expected to reach one million new cases globally by 2030 [6]. - Approximately 80% of patients with recurrent/metastatic HNSCC are HPV-negative, which is associated with worse survival outcomes and a critical unmet need for effective therapies [7].
Bicara Therapeutics Announces Publication of an Abstract with Updated Interim Data from Phase 1/1b Trial of Ficerafusp alfa in 1L R/M HNSCC at the 2025 ASCO Annual Meeting