Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA for 1L HPV-Negative R/M HNSCC
Bicara Therapeutics (Nasdaq: BCAX) announced the U.S. FDA granted Breakthrough Therapy Designation to ficerafusp alfa plus pembrolizumab for first-line treatment of metastatic or unresectable, recurrent HPV-negative HNSCC with PD-L1 CPS ≥1 (excluding HPV-positive oropharyngeal SCC) on Oct 13, 2025.
BTD was supported by Phase 1/1b cohorts presented at ASCO 2025 showing a median duration of response 21.7 months and median overall survival 21.3 months with a favorable safety profile. The designation enables increased FDA interaction, senior leadership involvement, and eligibility for rolling and priority review and supports the ongoing pivotal FORTIFI-HN01 trial.
Bicara Therapeutics (Nasdaq: BCAX) ha annunciato che la FDA statunitense ha concesso la Breakthrough Therapy Designation a ficerafusp alfa più pembrolizumab come trattamento di prima linea per HNSCC metastatico o non resecabile, ricorrente HPV-negativo con PD-L1 CPS ≥1 (escludendo HPV-positivo orofaringea SCC) il 13 ottobre 2025.
BTD è stato supportato da coorti di fase 1/1b presentate all'ASCO 2025 che mostrano una durata mediana della risposta di 21,7 mesi e una survival mediana globale di 21,3 mesi con un profilo di sicurezza favorevole. La designazione permette maggiore interazione con la FDA, coinvolgimento della direzione senior e l'idoneità per la revisione rolling e prioritária, e supporta lo studio pivotal FORTIFI-HN01 in corso.
Bicara Therapeutics (Nasdaq: BCAX) anunció que la FDA de EE. UU. otorgó la Designación de Terapia Innovadora a ficerafusp alfa más pembrolizumab como tratamiento de primera línea para HNSCC metastásica o no resecable, recurrente HPV-negativo con PD-L1 CPS ≥1 (excluyendo HPV-positivo orofaringe SCC) el 13 de octubre de 2025.
La BTD estuvo respaldada por cohortes de fase 1/1b presentadas en ASCO 2025 que mostraron una duración mediana de la respuesta de 21,7 meses y una supervivencia global mediana de 21,3 meses con un perfil de seguridad favorable. La designación permite una mayor interacción con la FDA, participación de la alta dirección y elegibilidad para revisión continua y prioritaria, y respalda el ensayo pivotal FORTIFI-HN01 en curso.
Bicara Therapeutics (Nasdaq: BCAX)는 미국 FDA가 ficerafusp alfa와 pembrolizumab을 HPV 음성 전이성 또는 재발성 HNSCC의 일차 치료로 허가받은 Breakthrough Therapy Designation를 부여했다고 2025년 10월 13일 발표했습니다. 이는 PD-L1 CPS ≥1 조건을 만족하며 HPV 양성 인두편평세포암은 제외합니다.
ASCO 2025에서 발표된 1/1b 코호트에 의해 반응 지속 기간의 중간값 21.7개월 및 전체 생존의 중간값 21.3개월의 우수한 안전성 프로필이 확인되어 BTD가 적용되었습니다. 이 지정은 FDA와의 상호작용 증가, 고위 경영진의 참여, 롤링 및 프라이어리티 리뷰 자격 부여를 가능하게 하며, 진행 중인 결정적 FORTIFI-HN01 시험을 지원합니다.
Bicara Therapeutics (Nasdaq : BCAX) a annoncé que la FDA américaine a accordé le Breakthrough Therapy Designation à ficerafusp alfa plus pembrolizumab comme traitement de première ligne pour le HNSCC métastatique ou non résécable, récurrent HPV-négatif avec PD-L1 CPS ≥1 (à l'exception du SCC oropharyngé HPV-positif) le 13 octobre 2025.
Le BTD a été soutenu par des cohorts de phase 1/1b présentées à l'ASCO 2025 montrant une durée médiane de réponse de 21,7 mois et une survie globale médiane de 21,3 mois avec un profil de sécurité favorable. Cette désignation permet une interaction accrue avec la FDA, l'implication de la direction et l'éligibilité à une revue roulante et prioritaire, et soutient l'essai pivot FORTIFI-HN01 en cours.
Bicara Therapeutics (Nasdaq: BCAX) gab bekannt, dass die US-amerikanische FDA eine Breakthrough Therapy Designation für Ficerafusp alfa plus Pembrolizumab als Erstbehandlung von metastasierendem oder unresectablem, rezidivierendem HPV-negativem HNSCC mit PD-L1 CPS ≥1 (ausgenommen HPV-positives Oropharynx-SCC) am 13. Oktober 2025 erteilt hat.
Die BTD wurde durch Phase-1/1b-Kohorten gestützt, die auf der ASCO 2025 präsentiert wurden und eine mediane Ansprechdauer von 21,7 Monaten sowie eine mediane Gesamtüberlebenszeit von 21,3 Monaten mit einem günstigen Sicherheitsprofil zeigten. Die Bezeichnung ermöglicht eine verstärkte Interaktion mit der FDA, die Einbindung der oberen Führungsebene und die Berechtigung für Rolling- und Priority-Reviews und unterstützt die laufende zentrale FORTIFI-HN01-Studie.
Bicara Therapeutics (Nasdaq: BCAX) أعلنت أن إدارة الغذاء والدواء الأمريكية منحت Designación de Terapia Innovadora لـ فِيسِرافَسُب ألفا مع pembrolizumab كعلاج خط أول لـ HNSCC ورمي HPV-سلبي متقدم أو متكرر غير قابل للإزالة، مع PD-L1 CPS ≥1 (باستثناء HPV-الموجب SCC البلعومي) في 13 أكتوبر 2025.
وقد دعمت Designación العلاجية من خلالكوهنات من المرحلة 1/1b التي عُرضت في ASCO 2025 والتي أظهرت مدة الاستجابة الوسيطـة 21.7 شهور و البقاء على قيد الحياة الوسيط الكلي 21.3 شهور مع ملف أمان مفضل. تسمح هذه الإشارة بزيادة التفاعل مع FDA، ومشاركة القيادة العليا، وإمكانية المراجعة المستمرة والأولوية، وتدعم تجربة FORTIFI-HN01 الحاسمة قيد التنفيذ.
Bicara Therapeutics (Nasdaq: BCAX)宣布美国食品药品监督管理局于 Breakthrough Therapy Designation 授予 ficerafusp alfa 与 pembrolizumab组合作为一线治疗，用于 HPV 阴性、转移性或无法切除的复发性 HNSCC，PD-L1 CPS ≥1（不包括 HPV 阳性的咽部鳞状细胞癌）于 2025 年 10 月 13 日。
BTD 得到了 ASCO 2025 年展示的 1/1b 阶段队列的支持，显示< b>响应持续时间的中位数为 21.7 个月、总体生存中位数为 21.3 个月，并具备良好的安全性特征。该指定使 FDA 的互动增加，高层领导参与，并具备滚动评审和优先审评的资格，支持正在进行的关键性 FORTIFI-HN01 试验。
- FDA Breakthrough Therapy Designation granted on Oct 13, 2025
- Median duration of response 21.7 months reported
- Median overall survival 21.3 months reported
- Eligible for rolling and priority review and more FDA engagement
- Supports progression to pivotal FORTIFI-HN01 trial
- Indication excludes HPV-positive oropharyngeal patients, narrowing eligible population
- Label limited to tumors with PD-L1 CPS ≥1, restricting patient pool
Insights
FDA granted Breakthrough Therapy Designation for Bicara Therapeutics’s ficerafusp alfa with pembrolizumab in 1L HPV-negative R/M HNSCC, supported by Phase 1/1b durability and survival signals.
The designation reflects regulatory recognition that the combination produced substantial clinical activity in a defined, high-need population. Reported metrics include a median duration of response of
Key dependencies include successful confirmation of these signals in the ongoing pivotal FORTIFI-HN01 trial and continued dialogue with the FDA under BTD. Watch for pivotal trial enrollment milestones and any confirmatory efficacy/safety readouts over the next 12–36 months as the primary near-term triggers for regulatory filing timelines.
BTD materially de-risks regulatory pathway and increases agency engagement for a therapy addressing HPV-negative R/M HNSCC.
BTD grants enhanced FDA interaction, potential rolling and priority review, and signals the agency views the therapy as a possible meaningful improvement over available options. The company cites durable responses and an overall survival median near
Risks remain: the designation does not guarantee approval and hinges on the pivotal FORTIFI-HN01 confirming the Phase 1/1b outcomes; monitor trial design details, primary endpoint timing, and interim analysis plans over the coming 12–24 months to assess whether the program can sustain the accelerated pathway.
Designation supported by results from multiple dose cohorts from the Phase 1/1b trial of ficerafusp alfa in 1L HPV-negative R/M HNSCC
BOSTON, Oct. 13, 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 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma.
This designation from the FDA underscores the growing recognition of HPV-negative HNSCC as a distinct clinical indication within head and neck cancer – one with particularly poor outcomes, limited therapeutic options, and that represents the vast majority of patients.
“This recognition highlights the urgent unmet need for patients with HPV-negative R/M HNSCC,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “It also reinforces our conviction that depth and durability of response, driven by ficerafusp alfa's ability to synergize with pembrolizumab and enable tumor penetration, are key to achieving long-term clinical benefit.”
BTD was supported by results from multiple Phase 1/1b dose cohorts evaluating ficerafusp alfa in combination with pembrolizumab in patients with 1L HPV-negative R/M HNSCC. Data most recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated deep and durable clinical benefit with a median duration of response of 21.7 months, and a median overall survival of 21.3 months, alongside a favorable safety and tolerability profile.
BTD is intended to expedite the development and review of potential new medicines that show substantial improvement over available therapies for serious or life-threatening conditions, providing greater interaction with the FDA, involvement of senior agency leadership, and eligibility for rolling and priority review.
“BTD provides external validation of the importance of ficerafusp alfa’s best-in-disease potential, and solidifies the foundation for our ongoing pivotal trial, FORTIFI-HN01,” said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. “We look forward to working closely with the FDA to bring this therapy to patients as quickly as possible.”
About FORTIFI-HN01
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 regulatory 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 designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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 targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses.
Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
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 first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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 targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. 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. These statements may be identified by words such as “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 contain identifying words. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation; the impact of Breakthrough Therapy Designation on the development and review of ficerafusp alfa, the timing and outcomes of regulatory submissions and reviews, express or implied statements regarding the clinical development of ficerafusp alfa; and the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy, depth, durability and tolerability. 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 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; regulatory developments in the United States and foreign countries; whether Bicara’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties described in greater detail under the caption “Risk Factors” in Bicara’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q,as well as any subsequent filings Bicara makes with the Securities and Exchange Commission. 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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FAQ
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