Bicara Therapeutics shows promising results in Phase 1/1b trial for head and neck cancer.

From GlobeNewswire: 2025-06-01 13:12:00

Bicara Therapeutics Inc. presented data from a Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab for recurrent/metastatic head and neck squamous cell carcinoma. Results showed a median duration of response of 21.7 months, with 80% of responders achieving ≥80% tumor shrinkage. The median overall survival was 21.3 months, with a 2-year overall survival rate of 46% in HPV-negative HNSCC patients. A conference call and webcast will be held today at 3:00 p.m. CT / 4:00 p.m. ET to discuss the data further.

The Phase 1/1b trial demonstrated deep and durable anti-tumor activity with improved overall survival in HPV-negative HNSCC patients. Key highlights include a median OS of 21.3 months, a 2-year OS rate of 46%, and 80% of responders achieving a deep response of ≥80% tumor shrinkage. The results support the advancement of the Phase 2/3 trial in the first-line recurrent/metastatic setting. The data show promising potential for ficerafusp alfa in addressing the critical unmet need in this patient population.



Read more at GlobeNewswire: Bicara Therapeutics Demonstrates Deep and Durable Responses