Bicara Therapeutics Announces First Patients Enrolled in FORTIFI-HN01, a Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Bicara Therapeutics (Nasdaq: BCAX) has initiated patient enrollment in FORTIFI-HN01, a pivotal Phase 2/3 trial evaluating ficerafusp alfa in combination with pembrolizumab for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
The global, randomized, double-blinded trial aims to enroll approximately 650 patients with R/M HNSCC, excluding HPV-positive oropharyngeal cases. Patients must have a PD-L1 CPS ≥1 and no prior systemic therapy in the R/M setting. The study's primary endpoints include overall response rate and overall survival.
Ficerafusp alfa is a first-in-class bifunctional antibody targeting EGFR and TGF-β. The trial's design was supported by encouraging interim Phase 1/1b data showing durable and meaningful anti-tumor activity when combined with pembrolizumab.
Bicara Therapeutics (Nasdaq: BCAX) ha avviato l'arruolamento dei pazienti nello studio FORTIFI-HN01, un trial fondamentale di fase 2/3 che valuta ficerafusp alfa in combinazione con pembrolizumab per il trattamento di prima linea del carcinoma squamoso della testa e del collo (HNSCC) ricorrente/metastatico.
Lo studio globale, randomizzato e in doppio cieco mira ad arruolare circa 650 pazienti con HNSCC R/M, escludendo i casi orofaringei positivi all'HPV. I pazienti devono avere un PD-L1 CPS ≥1 e non aver ricevuto terapie sistemiche precedenti nel contesto R/M. Gli obiettivi primari dello studio includono il tasso di risposta complessivo e la sopravvivenza complessiva.
Ficerafusp alfa è un anticorpo bifunzionale di prima classe che mira a EGFR e TGF-β. Il design dello studio è stato supportato da dati preliminari incoraggianti della fase 1/1b che mostrano un'attività anti-tumorale duratura e significativa quando combinata con pembrolizumab.
Bicara Therapeutics (Nasdaq: BCAX) ha iniciado la inscripción de pacientes en FORTIFI-HN01, un ensayo pivotal de fase 2/3 que evalúa ficerafusp alfa en combinación con pembrolizumab para el tratamiento de primera línea del carcinoma de células escamosas de cabeza y cuello (HNSCC) recurrente/metastásico.
El ensayo global, aleatorizado y doble ciego tiene como objetivo inscribir aproximadamente 650 pacientes con HNSCC R/M, excluyendo los casos orofaríngeos positivos para el VPH. Los pacientes deben tener un CPS de PD-L1 ≥1 y no haber recibido terapia sistémica previa en el contexto R/M. Los principales puntos finales del estudio incluyen la tasa de respuesta global y la supervivencia global.
Ficerafusp alfa es un anticuerpo bifuncional de primera clase que dirige EGFR y TGF-β. El diseño del ensayo fue respaldado por datos interinos alentadores de la fase 1/1b que muestran una actividad antitumoral duradera y significativa cuando se combina con pembrolizumab.
비카라 테라퓨틱스 (Nasdaq: BCAX)는 재발성/전이성 두경부 편평세포암(HNSCC)의 1차 치료를 평가하기 위한 중요한 2/3상 시험인 FORTIFI-HN01에 환자 등록을 시작했습니다. 피세라프스 알파는 펨브롤리주맙과 함께 사용됩니다.
이 글로벌, 무작위, 이중 맹검 시험은 HPV 양성의 인두암 케이스를 제외하고 약 650명의 R/M HNSCC 환자를 등록하는 것을 목표로 하고 있습니다. 환자는 PD-L1 CPS ≥1을 가져야 하며 R/M 환경에서 이전의 전신 요법을 받지 않아야 합니다. 이 연구의 주요 목표는 전체 반응률과 전체 생존율입니다.
피세라프스 알파는 EGFR과 TGF-β를 타겟으로 하는 첫 번째 클래스의 이중 기능 항체입니다. 이 시험의 설계는 펨브롤리주맙과 함께 사용할 때 지속적이고 의미 있는 항종양 활성을 보여주는 초기 1/1b상 데이터를 통해 지원되었습니다.
Bicara Therapeutics (Nasdaq: BCAX) a commencé le recrutement de patients pour l'essai FORTIFI-HN01, un essai pivot de phase 2/3 qui évalue ficerafusp alfa en combinaison avec pembrolizumab pour le traitement de première ligne du carcinome épidermoïde récurrent/métastatique de la tête et du cou (HNSCC).
L'essai mondial, randomisé et double aveugle vise à inclure environ 650 patients atteints de HNSCC R/M, à l'exclusion des cas oropharyngés positifs pour le HPV. Les patients doivent avoir un CPS de PD-L1 ≥1 et ne pas avoir reçu de thérapie systémique préalable dans le contexte R/M. Les principaux objectifs de l'étude comprennent le taux de réponse global et la survie globale.
Ficerafusp alfa est un anticorps bifonctionnel de première classe ciblant EGFR et TGF-β. La conception de l'essai a été soutenue par des données intermédiaires encourageantes de la phase 1/1b montrant une activité antitumorale durable et significative lorsqu'elle est combinée avec pembrolizumab.
Bicara Therapeutics (Nasdaq: BCAX) hat die Rekrutierung von Patienten für die FORTIFI-HN01-Studie begonnen, einer entscheidenden Phase 2/3-Studie zur Bewertung von ficerafusp alfa in Kombination mit Pembrolizumab als Erstlinientherapie für wiederkehrendes/metastasiertes Plattenepithelkarzinom der Kopf- und Halsregion (HNSCC).
Die globale, randomisierte, doppelblinde Studie zielt darauf ab, etwa 650 Patienten mit R/M HNSCC zu rekrutieren, wobei HPV-positive Hals-Rachen-Karzinome ausgeschlossen werden. Die Patienten müssen einen PD-L1 CPS von ≥1 haben und dürfen zuvor keine systemische Therapie im R/M-Kontext erhalten haben. Die primären Endpunkte der Studie sind die Gesamtrate an Ansprechenden und die Gesamtüberlebenszeit.
Ficerafusp alfa ist ein zweifunktionaler Antikörper der ersten Klasse, der EGFR und TGF-β angreift. Das Design der Studie wurde durch ermutigende vorläufige Daten aus der Phase 1/1b gestützt, die eine dauerhafte und signifikante antitumorale Aktivität in Kombination mit Pembrolizumab zeigen.
- Advancement to late-stage clinical development with Phase 2/3 trial initiation
- Large-scale trial with 650 patients targeting both accelerated and full approval pathways
- Encouraging Phase 1/1b interim data showing durable anti-tumor activity
- None.
Insights
This pivotal trial launch represents a significant milestone in both Bicara's corporate evolution and the head and neck cancer treatment landscape. The trial's sophisticated design features several strategic elements that enhance its probability of success:
The exclusion of HPV-positive oropharyngeal cases is particularly noteworthy, as these patients typically have better prognosis and could potentially confound efficacy signals. By focusing on the higher-risk population, Bicara is targeting the segment with the greatest unmet need and potential for meaningful clinical impact.
The dual targeting mechanism of ficerafusp alfa - combining EGFR inhibition with TGF-β modulation - represents an innovative approach that could potentially overcome resistance mechanisms seen with current therapies. This is particularly relevant given that EGFR is overexpressed in 90% of HNSCC cases, while TGF-β is a known mediator of immunosuppression and treatment resistance.
The trial's dual primary endpoint strategy, incorporating both overall response rate and overall survival, is cleverly designed to support both accelerated and full approval pathways. This could potentially accelerate time to market while still generating the robust survival data needed for full approval.
From a market perspective, the positioning alongside pembrolizumab (currently the standard of care) suggests Bicara is pursuing an addition to rather than replacement of current treatment paradigms. The PD-L1 CPS ≥1 requirement aligns with pembrolizumab's approved indication, facilitating potential regulatory and commercial adoption.
The 650-patient enrollment target is substantial for this indication, providing sufficient statistical power to detect meaningful differences in survival outcomes. This robust sample size, combined with the global nature of the trial, positions the study well for regulatory success and subsequent market access considerations.
BOSTON, Feb. 11, 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 first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). 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).
“This is a key milestone for Bicara and represents our transition into a late-stage clinical development company,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “Supported by encouraging interim Phase 1/1b data, which demonstrated durable and clinically meaningful anti-tumor activity with ficerafusp alfa in combination with pembrolizumab, FORTIFI-HN01 will evaluate the potential of ficerafusp alfa as a first-in-class treatment option for patients with advanced head and neck squamous cell carcinoma. The thoughtful and efficient design of this trial underscores our strategic approach to rapidly advancing treatment options for these patients, with the goal of addressing the significant unmet needs in this challenging disease.”
“Head and neck squamous cell carcinoma is a cancer of growing concern across the world,” said John Kaczmar, MD, Medical University of South Carolina Hollings Cancer Center. “Incidence is rising, yet survival rates remain low, particularly for patients with HPV-negative disease, underscoring the urgent need for innovative treatment options. I’m encouraged by the early signs of clinical activity in these patients we have seen treated with ficerafusp alfa and hopeful it will help address this area of significant unmet need. I look forward to contributing to this important trial to advance new possibilities for our patients.”
FORTIFI-HN01 is a global, randomized, double-blinded, placebo-controlled, pivotal Phase 2/3 trial that aims to enroll approximately 650 R/M HNSCC patients, excluding patients with human papillomavirus (HPV)-positive with oropharyngeal squamous cell carcinoma. Patients enrolled in the trial must have a PD-L1 CPS greater than or equal to one, and not have received systemic therapy in the R/M setting. The primary endpoints are overall response rate based on RECIST v1.1 and overall survival, with results potentially supporting filings for both accelerated approval and full approval. Secondary endpoints include progression free survival and duration of response.
About Head and Neck Squamous Cell Carcinoma
Head and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. HNSCC is one of the most common cancers in the United States and globally with a rising incidence anticipated to reach one million new global cases annually by 2030. Ten percent of HNSCC patients are diagnosed with metastatic disease and up to
Most cases of HNSCC are thought to result from accumulated mutations caused by carcinogenic exposures such as tobacco smoke or HPV infection. Approximately
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 plans and timelines for the clinical development of ficerafusp alfa in combination with pembrolizumab, the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy and tolerability, the FORTIFI-HN01 trial design and Bicara’s regulatory approval plans. 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 related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct and enrollment of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials and regulatory developments in the United States and foreign countries. 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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