Bicara Therapeutics' stock falls 43% after early-stage trial data reveals mixed results for head and neck cancer therapy.

Bicara Therapeutics shares fell 43% after the company released early-stage trial data for its lead asset, ficerafusp alfa, in combination therapy for head and neck cancer. The data showed mixed results, with the combination regimen achieving an overall response rate of 35%, but with a complete response rate of only 7%. The company's stock price dropped significantly following the release of the trial data.

Bicara Therapeutics Inc. (Nasdaq: BCAX) saw its stock price fall by 43% on May 22, 2025, following the release of early-stage trial data for its lead asset, ficerafusp alfa. The data, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, showed mixed results for the combination therapy aimed at treating head and neck cancer.

The interim data revealed an overall response rate of 35%, with a complete response rate of only 7%. These results, while showing some promise, fell short of expectations and contributed to the significant drop in the company's stock price. The data was part of a Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab for first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

The stock price drop underscores the market's cautious response to the trial results, which may reflect concerns about the efficacy and safety of ficerafusp alfa, as well as the potential risks and uncertainties associated with its development. Bicara Therapeutics will host a conference call on June 1, 2025, to discuss the full dataset post-presentation, providing investors and stakeholders with more detailed insights into the trial's outcomes.

Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by addressing barriers within the tumor microenvironment. It combines an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). The drug is intended to improve drug delivery and enhance anti-tumor responses in tumors.

Despite the mixed trial results, the company remains committed to addressing the significant unmet need for effective therapies in head and neck cancer, particularly for HPV-negative patients who often have worse survival outcomes. The interim data showed encouraging signals in this population, with a 64% objective response rate and a median overall survival exceeding 20 months.

Investors should closely monitor the upcoming conference call and the full dataset presentation to gain a better understanding of the trial's implications for Bicara Therapeutics and the broader biopharmaceutical landscape.

References:
[1] https://www.nasdaq.com/articles/bicara-therapeutics-inc-announces-updated-interim-data-phase-1-1b-trial-ficerafusp-alfa