Core Insights - Bicara Therapeutics presented preliminary data from a Phase 1b expansion cohort evaluating ficerafusp alfa in combination with pembrolizumab for treating first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), showing rapid, deep, and durable responses with a well-tolerated safety profile [1][3][4] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa being its lead program [12][13] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration and improve survival outcomes by combining an EGFR-directed antibody with a TGF-β ligand trap [2][10] Clinical Data - The Phase 1b expansion cohort data indicated a 48% confirmed overall response rate (ORR) for the 2000mg every other week (Q2W) dosing regimen, with 26% of patients achieving a complete response (CR) and 77% of responders showing at least 80% tumor shrinkage [3][4] - The safety profile of the 2000mg Q2W regimen was consistent with previous findings for ficerafusp alfa combined with pembrolizumab [3][4] - Updated biomarker results confirmed that the 2000mg Q2W regimen maintains TGF-β inhibition and immune activation while delivering deep responses [5] Future Development Plans - The company plans to develop a loading and every-three-week maintenance regimen for ficerafusp alfa, pending regulatory alignment [1][6] - Ongoing enrollment in the pivotal FORTIFI-HN01 study continues to evaluate ficerafusp alfa at 1500mg weekly in combination with pembrolizumab [6][11] Industry Context - HNSCC is one of the most common cancers globally, with a rising incidence expected to reach one million new cases annually by 2030, highlighting a significant unmet need for effective therapies [8][9]
Ficerafusp Alfa 2000mg Q2W Demonstrates Deep, Durable Responses in 1L R/M HPV-Negative HNSCC and Supports Development of Less Frequent Dosing Regimen