Bicara reaches substantial enrollment in HPV-negative head and neck cancer trial

Bicara Therapeutics reported on November 9, 2026 that it had achieved substantial enrollment in the FORTIFI-HN01 pivotal trial in first-line recurrent or metastatic HPV-negative head and neck squamous cell carcinoma, positioning the company for topline results from an interim analysis in mid-2027.¹

The company is also continuing enrollment in a separate dosing study. FORTIFI-FLEX is a randomized, open-label trial testing ficerafusp alfa given as a 12-week loading dose of 1500mg weekly followed by maintenance dosing of 2250mg every three weeks, compared against a straight 1500mg weekly regimen, both arms paired with pembrolizumab.¹ Bicara said it expects data from this study to be available around the time of any U.S. approval decision in the first-line HPV-negative HNSCC indication.¹

Beyond head and neck cancer, Bicara plans to present data in January 2027 from a Phase 1b expansion cohort testing ficerafusp alfa alone and combined with pembrolizumab in third-line-plus metastatic colorectal cancer patients with RAS/BRAF wild-type, microsatellite-stable disease.¹ The company will also present preclinical findings on tumor-targeted TGF-β neutralization and its effects on fibrosis and drug penetration at the ESMO Immuno-Oncology & Advanced Therapies Congress 2026, held December 14-16 in London.¹

On finances, Bicara held $442.3 million in cash, cash equivalents and marketable securities as of September 30, 2026, up from $414.8 million at the end of 2025.¹ The company said this is expected to fund operations into the first half of 2029.¹ Net loss for the third quarter totaled $71.2 million, compared to $36.3 million in the third quarter of 2025.¹