Bicara Therapeutics Presents Phase 1/1b Dose Expansion Results with Ficerafusp Alfa in Advanced Squamous Cancer of the Anal Canal at the 2025 ASCO Gastrointestinal Cancers Symposium
Bicara Therapeutics (Nasdaq: BCAX) presented Phase 1/1b dose expansion results for ficerafusp alfa combined with pembrolizumab in treating advanced squamous cancer of the anal canal (SCAC). The study involved 28 patients who received 1-2 prior chemotherapy lines.
Key results include a 25.0% confirmed overall response rate (7/28 patients), with 6 partial responses and 1 complete response. The median progression-free survival was 2.9 months, with a 40.7% PFS rate at 12 months. Treatment-related adverse events included acneiform dermatitis (57.1%), epistaxis (50.0%), and pruritus (46.4%).
Ficerafusp alfa is a first-in-class bifunctional antibody targeting EGFR and TGF-β. The data suggests improved efficacy compared to historical pembrolizumab monotherapy in SCAC, with responses observed even in patients with liver metastases.
Bicara Therapeutics (Nasdaq: BCAX) ha presentato i risultati dell'espansione della dose della Fase 1/1b per ficerafusp alfa in combinazione con pembrolizumab nel trattamento del carcinoma squamoso avanzato del canale anale (SCAC). Lo studio ha coinvolto 28 pazienti che avevano ricevuto 1-2 linee di chemioterapia precedenti.
I risultati chiave includono un tasso di risposta complessiva confermata del 25.0% (7/28 pazienti), con 6 risposte parziali e 1 risposta completa. La sopravvivenza libera da progressione mediana è stata di 2,9 mesi, con un tasso di PFS del 40,7% a 12 mesi. Gli eventi avversi correlati al trattamento comprendevano dermatite acneiforme (57,1%), epistassi (50,0%) e prurito (46,4%).
Ficerafusp alfa è un anticorpo bifunzionale di prima classe che mira a EGFR e TGF-β. I dati suggeriscono un'efficacia migliorata rispetto alla monoterapia storica con pembrolizumab nel SCAC, con risposte osservate anche in pazienti con metastasi epatiche.
Bicara Therapeutics (Nasdaq: BCAX) presentó los resultados de expansión de dosis de la Fase 1/1b para ficerafusp alfa combinado con pembrolizumab en el tratamiento del cáncer escamoso avanzado del canal anal (SCAC). El estudio involucró a 28 pacientes que recibieron de 1 a 2 líneas de quimioterapia previas.
Los resultados clave incluyen una tasa de respuesta global confirmada del 25.0% (7/28 pacientes), con 6 respuestas parciales y 1 respuesta completa. La supervivencia libre de progresión mediana fue de 2,9 meses, con una tasa de PFS del 40,7% a los 12 meses. Los eventos adversos relacionados con el tratamiento incluyeron dermatitis acneiforme (57,1%), epistaxis (50,0%) y prurito (46,4%).
Ficerafusp alfa es un anticuerpo bifuncional de primera clase que se dirige a EGFR y TGF-β. Los datos sugieren una eficacia mejorada en comparación con la monoterapia histórica con pembrolizumab en SCAC, con respuestas observadas incluso en pacientes con metástasis hepáticas.
비카라 테라퓨틱스 (Nasdaq: BCAX)는 피세라푼스 알파와 펨브롤리주맙을 병용하여 진행성 항문관 편평 세포암(SCAC) 치료에 대한 1/1b 상 단계 용량 확장 결과를 발표했습니다. 이 연구는 1-2회의 이전 화학요법을 받은 28명의 환자를 포함했습니다.
주요 결과는 확인된 전체 반응률 25.0% (7/28 환자)로, 6명의 부분 반응과 1명의 완전 반응이 포함됩니다. 중앙 무진행 생존 기간은 2.9개월이며, 12개월 시 PFS 비율은 40.7%입니다. 치료 관련 부작용으로는 여드름 유사 피부염(57.1%), 코출혈(50.0%), 가려움증(46.4%)이 포함되었습니다.
피세라푼스 알파는 EGFR과 TGF-β를 타겟으로 하는 최초의 이중 기능 항체입니다. 데이터는 SCAC에서 펨브롤리주맙 단독요법에 비해 개선된 효능을 제시하며, 간 전이가 있는 환자에서도 반응이 관찰되었습니다.
Bicara Therapeutics (Nasdaq: BCAX) a présenté les résultats de l'expansion de dose de la Phase 1/1b pour ficerafusp alfa en combinaison avec pembrolizumab dans le traitement du cancer squameux avancé du canal anal (SCAC). L'étude a impliqué 28 patients ayant reçu 1 à 2 lignes de chimiothérapie antérieures.
Les résultats clés comprennent un taux de réponse globale confirmé de 25,0% (7/28 patients), avec 6 réponses partielles et 1 réponse complète. La survie médiane sans progression était de 2,9 mois, avec un taux de PFS de 40,7% à 12 mois. Les événements indésirables liés au traitement comprenaient une dermatite acnéiforme (57,1%), des épistaxes (50,0%) et des prurits (46,4%).
Ficerafusp alfa est un anticorps bifonctionnel de première classe ciblant l'EGFR et le TGF-β. Les données suggèrent une efficacité améliorée par rapport à la monothérapie historique avec pembrolizumab dans le SCAC, avec des réponses observées même chez des patients présentant des métastases hépatiques.
Bicara Therapeutics (Nasdaq: BCAX) präsentierte die Ergebnisse der Dosis-Erweiterung der Phase 1/1b für ficerafusp alfa, kombiniert mit Pembrolizumab, zur Behandlung von fortgeschrittenem squamösem Analkanzer (SCAC). Die Studie umfasste 28 Patienten, die zuvor 1-2 Chemotherapie-Linien erhalten hatten.
Wesentliche Ergebnisse umfassen eine bestätigte Gesamtrücklaufquote von 25,0% (7/28 Patienten), mit 6 partiellen und 1 vollständigen Rückmeldung. Das mediane progressionsfreie Überleben betrug 2,9 Monate, mit einer PFS-Rate von 40,7% nach 12 Monaten. Zu den behandlungsbezogenen Nebenwirkungen gehörten akneiforme Dermatitis (57,1%), Nasenbluten (50,0%) und Juckreiz (46,4%).
Ficerafusp alfa ist ein neuartiger bifunktioneller Antikörper, der auf EGFR und TGF-β abzielt. Die Daten deuten auf eine verbesserte Wirksamkeit im Vergleich zur historischen Monotherapie mit Pembrolizumab bei SCAC hin, mit Reaktionen, die sogar bei Patienten mit Lebermetastasen beobachtet wurden.
- 25% confirmed overall response rate in Phase 1/1b trial
- 40.7% progression-free survival rate at 12 months
- Responses observed in patients with liver metastases
- Tolerable safety profile demonstrated
- Relatively short median progression-free survival of 2.9 months
- High rate of adverse events (57.1% dermatitis, 50% epistaxis)
Insights
The Phase 1/1b trial results for Bicara's ficerafusp alfa represent a significant development in the treatment landscape for squamous cancer of the anal canal (SCAC). The 25% confirmed overall response rate in 28 heavily pretreated patients is particularly impressive when compared to historical pembrolizumab monotherapy data, which typically shows response rates in the 10-15% range for this indication.
Several aspects of the data stand out as especially promising:
- The achievement of responses regardless of PD-L1 status suggests broad applicability
- The 40.7% PFS rate at 12 months indicates durable benefit in a substantial subset of patients
- Responses in patients with liver metastases are remarkable, as these patients typically have poor prognosis and treatment options
The bifunctional mechanism targeting both EGFR and TGF-β represents a novel approach that could potentially overcome resistance mechanisms to existing therapies. The safety profile, while showing expected EGFR-related adverse events, appears manageable with no new safety signals.
These results have broader implications for Bicara's development strategy. The data support expansion into other squamous cell carcinomas, particularly head and neck cancer, where the dual mechanism could provide advantages over current standards of care. For investors, this positive signal in a difficult-to-treat indication validates the platform technology and suggests potential for multiple valuable indications.
BOSTON, Jan. 27, 2025 (GLOBE NEWSWIRE) -- 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.
About Squamous Cancer of the Anal Canal
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.
About Ficerafusp Alfa
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.
About Bicara Therapeutics
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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of ficerafusp alfa, the potential efficacy and safety of ficerafusp alfa in combination with pembrolizumab in SCAC, and plans for the clinical development of ficerafusp alfa in combination with pembrolizumab. The words “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Bicara’s most recent Quarterly Report on Form 10-Q for the period ended September 30, 2024, and filed with the Securities and Exchange Commission (SEC), as well as any subsequent filings that Bicara makes with the SEC. In addition, any forward-looking statements represent Bicara’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Bicara explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
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