Core Insights - The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) expressing PD-L1 with CPS ≥1, specifically for HPV-negative cases [1][2][3] 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 Insights - The BTD was supported by results from multiple Phase 1/1b dose cohorts, showing a median duration of response of 21.7 months and a median overall survival of 21.3 months, alongside a favorable safety profile [3] - The ongoing pivotal trial, FORTIFI-HN01, aims to enroll approximately 650 patients with R/M HNSCC, focusing on overall response rate and overall survival as primary endpoints [5][9] Industry Context - HPV-negative HNSCC is recognized as a distinct clinical indication with poor outcomes and limited treatment options, representing a significant unmet need in oncology [2][7] - HNSCC is one of the most common cancers globally, with an anticipated rise to one million new cases annually by 2030, and approximately 80% of R/M HNSCC cases are HPV-negative [6][7]
Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA for 1L HPV-Negative R/M HNSCC