Core Insights - Bicara Therapeutics Inc. presented data from the Phase 1/1b dose expansion cohort of ficerafusp alfa combined with pembrolizumab for treating second line or later squamous cancer of the anal canal (SCAC) at the 2025 ASCO Gastrointestinal Cancers Symposium [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 [8] Drug Mechanism and Efficacy - Ficerafusp alfa is a first-in-class bifunctional antibody targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β), potentially enhancing anti-tumor activity [6][8] - The combination of ficerafusp alfa and pembrolizumab showed a confirmed overall response rate of 25.0% in a cohort of 28 patients, with 6 partial responses and 1 complete response [6] - The median progression-free survival (PFS) was reported at 2.9 months, with a 12-month PFS rate of 40.7% [6] Clinical Insights - Preliminary data indicated improved efficacy in SCAC patients, including those with liver metastases, suggesting the combination may enhance treatment outcomes compared to historical data with pembrolizumab alone [2][6] - The safety profile was deemed tolerable, with common treatment-related adverse events including acneiform dermatitis (57.1%), epistaxis (50.0%), and pruritus (46.4%) [6] Future Development - The data supports further investigation into the combination's potential in treating squamous cell carcinomas, particularly in first-line recurrent/metastatic head and neck squamous cell carcinoma [2][6]
Bicara Therapeutics Presents Phase 1/1b Dose Expansion Results with Ficerafusp Alfa in Advanced Squamous Cancer of the Anal Canal at the 2025 ASCO Gastrointestinal Cancers Symposium