Ficerafusp alfa

Jan. 27, 2025 -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the presentation of data from the Phase 1/1b dose expansion cohort of ficerafusp alfa in combination with pembrolizumab in patients with second line (2L) or later squamous cancer of the anal canal (SCAC). The results were presented in a poster session during the 2025 ASCO Gastrointestinal (GI) Cancers Symposium on Saturday, January 25, 2025. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β), and is being evaluated in multiple solid tumor types. “We are encouraged by the preliminary data in SCAC, which demonstrate enhanced efficacy of the combination of ficerafusp alfa and pembrolizumab in a high-need patient population,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “The addition of ficerafusp alfa shows the potential to improve efficacy compared to historical data with pembrolizumab monotherapy in SCAC, with increased overall response rate, disease control rate, and 12-month progression-free survival, indicative of improved speed, depth, and durability of response. Importantly, responses were observed even in patients with liver metastases, which is a significant outcome in this setting. These data provide additional insights into the complimentary mechanisms of ficerafusp alfa and pembrolizumab, and support further development in squamous cell carcinomas, including first-line recurrent/metastatic head and neck squamous cell carcinoma.” “These early data with ficerafusp alfa and pembrolizumab suggest that ficerafusp alfa could play an important role in the future treatment of SCAC, underscoring the need for further investigation to assess the combination's potential in improving outcomes for patients,” said Van K. Morris, MD, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. Presentation Highlights: As of the data cut-off date of December 5, 2024, the single-arm, multicenter dose expansion cohort from an ongoing Phase 1/1b trial evaluated ficerafusp alfa in combination with pembrolizumab in 28 patients with immune checkpoint inhibitor-naive SCAC that was locally advanced/unresectable or metastatic, and who had received 1-2 prior lines of chemotherapy. The confirmed overall response rate was 25.0% (7/28 patients), irrespective of PD-L1 CPS score, including 6 partial responses (PR) and 1 complete response. In addition to the confirmed responses, there was 1 patient pending a confirmed PR. Median progression-free survival (PFS) was 2.9 months and the PFS rate at 12 months was 40.7% (27 evaluable patients). Tolerable safety profile with the most common treatment-related adverse events of any grade including, acneiform dermatitis (16/28 patients; 57.1%), epistaxis (14/28 patients; 50.0%), and pruritus (13/28 patients; 46.4%). Presentation Details: Title: Preliminary Phase 1/1b dose expansion results of the bifunctional EGFR/TGFβ inhibitor ficerafusp alfa (BCA101) with pembrolizumab in patients with squamous cell carcinoma of the anal canal Presenter: Van K. Morris, MD, Associate Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center The poster presentation is available on the Bicara website under the Presentations & Publications section. Squamous cancer of the anal canal (SCAC) is the most common type of anal canal cancer, with an incidence in the United States. SCAC is typically associated with prior Human Papillomavirus (HPV) infection. Treatment is most commonly chemoradiation for patients with localized disease at diagnosis. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment. Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X. The content above comes from the network. if any infringement, please contact us to modify.