Investing.com -- Shares of Bicara Therapeutics Inc. (NASDAQ:BCAX) plummeted 30% in after-hours trading following the release of interim data from a clinical trial. The biopharmaceutical company, which specializes in bifunctional therapies for solid tumors, shared an abstract with updated results from its Phase 1/1b trial of ficerafusp alfa in combination with pembrolizumab for patients with first line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The data, published on the American Society of Clinical Oncology (ASCO) Annual Meeting website, precedes a more detailed presentation scheduled for June 1, 2025.
Despite the company’s positive outlook on the interim data, which highlighted an objective response rate of 64% in the human papillomavirus (HPV)-negative population, and a median progression-free survival of 9.8 months, investors reacted negatively to the news. The 12-month overall survival rate was reported at 61%, with median overall survival (mOS) and median duration of response (DOR) not yet reached, suggesting mOS could surpass 20 months.
David Raben, MD, Chief Medical (TASE:BLWV) Officer of Bicara Therapeutics, expressed optimism about the drug’s potential, noting the meaningful improvement over historical benchmarks for patients with HPV-negative disease—a group with a high unmet need and typically worse survival outcomes. He emphasized the drug’s design to enhance tumor penetration, which appears to lead to durable responses and potentially prolonged overall survival.
The safety findings were reported to be consistent with the known profiles of ficerafusp alfa and pembrolizumab, and post-treatment data from tumor biopsies indicated a promising downregulation of phospho-SMAD2, supporting targeted TGF-β inhibition.
The full dataset, including overall survival and duration of response data, will be presented during an oral session at the ASCO Annual Meeting, with Christine Chung, MD, Chair of the Department of Head and Neck-Endocrine Oncology at Moffitt Cancer Center, leading the presentation.
Investors’ reaction to the abstract’s publication and the upcoming conference call to discuss the data underscores the volatile nature of biopharmaceutical stocks, particularly those in the clinical trial phase. Bicara Therapeutics’ stock movement reflects the market’s sensitivity to new data and the inherent risks associated with drug development.
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