Bicara Cancer Drug Doubles Survival Rate to 31% in Head and Neck Trial

Bicara Therapeutics’ ficerafusp alfa combined with pembrolizumab showed an estimated 31% three-year survival rate in patients with an advanced form of head and neck cancer.

"At our pivotal study dose of 1500mg QW, an estimated one in three patients was alive at three years – approximately doubling the survival rate observed in retrospective analysis with standard of care pembrolizumab in HPV-negative patients,” Bill Schelman, Chief Medical Officer of Bicara Therapeutics, said.

The Phase 1/1b study data for the 1500mg weekly dose showed a 54% confirmed overall response rate and a 25% complete response rate, where patients showed no detectable cancer. The combination achieved a median progression-free survival of 9.9 months and a median overall survival of 21.3 months.

The positive results reinforce the potential for ficerafusp alfa to become a best-in-class treatment, targeting the difficult-to-treat HPV-negative head and neck squamous cell carcinoma (HNSCC). The drug is currently being evaluated in a pivotal Phase 3 trial.

The extended follow-up data, to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, comes from a study of about 90 patients with first-line recurrent or metastatic HNSCC. The trial tested three different dose cohorts, with the 1500mg weekly dose identified for the pivotal study.

Ficerafusp alfa is a first-in-class bifunctional antibody that targets both the epidermal growth factor receptor (EGFR) and neutralizes transforming growth factor beta (TGF-β). The company said biomarker analyses confirmed this TGF-β inhibition was the mechanistic driver behind the deep and durable responses observed in the trial.

Across the 1500mg cohort, 80% of responders achieved a deep response, defined as at least 80% tumor shrinkage. A pooled analysis across all dose cohorts showed these deep responses translated into significantly longer durability, progression-free survival, and overall survival.

The combination with Merck’s blockbuster immunotherapy pembrolizumab highlights a growing trend in oncology of pairing novel agents with established checkpoint inhibitors to improve patient outcomes. The U.S. Food and Drug Administration has already granted Breakthrough Therapy Designation to the combination for this indication.

The strong three-year data provides a significant validation for Bicara's TGF-β trapping mechanism ahead of primary data from its ongoing pivotal Phase 3 study, FORTIFI-HN01. Investors will now be focused on the successful execution and eventual readout of that trial as the next major catalyst for the company.

This article is for informational purposes only and does not constitute investment advice.