Bicara Therapeutics Announces Encouraging Data for Ficerafusp Alfa in Combination with Pembrolizumab for Second Line Anal Cancer
Bicara Therapeutics, a clinical-stage biopharmaceutical company, recently presented data from the Phase 1/1b dose expansion cohort of their investigational therapy, ficerafusp alfa, in combination with pembrolizumab for patients with second line (2L) or later squamous cancer of the anal canal (SCAC). The results were shared during the 2025 ASCO Gastrointestinal (GI) Cancers Symposium.
What is Ficerafusp Alfa?
Ficerafusp alfa is a first-in-class bifunctional antibody developed by Bicara Therapeutics. It is designed to combine two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody and a domain that binds to human TGF-β. This unique design allows ficerafusp alfa to target both EGFR and TGF-β, providing a potential therapeutic advantage in treating solid tumors.
Study Findings
The Phase 1/1b study enrolled 27 patients with 2L or later SCAC. The primary endpoints were safety, tolerability, and preliminary efficacy. The data presented showed that the combination of ficerafusp alfa and pembrolizumab was generally well-tolerated. The most common adverse events were fatigue, diarrhea, and rash. No dose-limiting toxicities were reported. Preliminary efficacy data showed that 11 out of 27 patients (41%) achieved an objective response, which included complete responses in three patients and partial responses in eight patients.
Implications for Patients
For patients with SCAC, the current standard of care includes chemotherapy or radiation therapy. However, these treatments often come with significant side effects and limited efficacy. The results from this study suggest that the combination of ficerafusp alfa and pembrolizumab could offer a more effective and tolerable treatment option. Further studies are needed to confirm these findings and establish the optimal dosing regimen.
Global Impact
The potential impact of this treatment goes beyond the SCAC patient population. The unique mechanism of action of ficerafusp alfa, targeting both EGFR and TGF-β, makes it a promising candidate for the treatment of other solid tumors as well. If successful in future trials, this therapy could change the landscape of cancer treatment, offering a more effective and targeted approach for various cancer types.
Conclusion
Bicara Therapeutics’ presentation of the Phase 1/1b data for ficerafusp alfa in combination with pembrolizumab for second line or later SCAC marks an encouraging step forward in the development of this innovative bifunctional therapy. The data suggests that this combination is generally well-tolerated and shows preliminary efficacy. Further studies are needed to confirm these findings and establish the optimal dosing regimen. If successful, this treatment could offer a more effective and tolerable option for patients with SCAC and potentially other solid tumors.
- Bicara Therapeutics presented data from the Phase 1/1b dose expansion cohort of ficerafusp alfa in combination with pembrolizumab for second line or later SCAC at the 2025 ASCO GI Cancers Symposium.
- Ficerafusp alfa is a first-in-class bifunctional antibody that targets both EGFR and TGF-β.
- The combination of ficerafusp alfa and pembrolizumab was generally well-tolerated in the Phase 1/1b study, with common adverse events being fatigue, diarrhea, and rash.
- Preliminary efficacy data showed that 11 out of 27 patients (41%) achieved an objective response, including complete and partial responses.
- If successful in future trials, ficerafusp alfa could offer a more effective and tolerable treatment option for patients with SCAC and potentially other solid tumors.
