BeiGene Provides Update on the Ociperlimab (BGB-A1217) Clinical Development Program
BeiGene (NASDAQ: ONC) announced the discontinuation of its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody intended for lung cancer treatment. The decision follows a recommendation from the Independent Data Monitoring Committee to terminate the ongoing Phase 3 AdvanTIG-302 trial after a pre-planned futility analysis indicated the study was unlikely to meet its primary endpoint of overall survival.
The company reported no new safety signals were observed during the trial. BeiGene, which plans to change its name to BeOne Medicines , will share the study results in the future to contribute to the scientific understanding of anti-TIGIT activity. The company maintains its focus on developing innovative and accessible cancer treatments.
BeiGene (NASDAQ: ONC) ha annunciato la cessazione del suo programma di sviluppo clinico per ociperlimab (BGB-A1217), un anticorpo anti-TIGIT destinato al trattamento del cancro ai polmoni. La decisione segue una raccomandazione del Comitato Indipendente di Monitoraggio dei Dati per terminare l'attuale studio di Fase 3 AdvanTIG-302 dopo un'analisi di inutilità pre-programmata che ha indicato che lo studio era improbabile che raggiungesse il suo obiettivo primario di sopravvivenza complessiva.
L'azienda ha riportato che non sono stati osservati nuovi segnali di sicurezza durante lo studio. BeiGene, che prevede di cambiare nome in BeOne Medicines, condividerà i risultati dello studio in futuro per contribuire alla comprensione scientifica dell'attività anti-TIGIT. L'azienda mantiene il suo focus sullo sviluppo di trattamenti innovativi e accessibili per il cancro.
BeiGene (NASDAQ: ONC) anunció la interrupción de su programa de desarrollo clínico para ociperlimab (BGB-A1217), un anticuerpo anti-TIGIT destinado al tratamiento del cáncer de pulmón. La decisión sigue una recomendación del Comité Independiente de Monitoreo de Datos para terminar el actual ensayo de Fase 3 AdvanTIG-302 después de un análisis de inutilidad preplaneado que indicó que el estudio era poco probable que alcanzara su objetivo primario de supervivencia general.
La compañía informó que no se observaron nuevas señales de seguridad durante el ensayo. BeiGene, que planea cambiar su nombre a BeOne Medicines, compartirá los resultados del estudio en el futuro para contribuir a la comprensión científica de la actividad anti-TIGIT. La empresa mantiene su enfoque en desarrollar tratamientos innovadores y accesibles para el cáncer.
BeiGene (NASDAQ: ONC)는 폐암 치료를 위해 설계된 항-TIGIT 항체인 ociperlimab (BGB-A1217)의 임상 개발 프로그램 중단을 발표했습니다. 이 결정은 독립 데이터 모니터링 위원회의 권고에 따라 3상 AdvanTIG-302 시험을 종료하기로 한 것으로, 사전 계획된 무용성 분석 결과 연구가 전체 생존이라는 주요 목표를 달성할 가능성이 낮다는 것을 나타냈습니다.
회사는 시험 중에 새로운 안전 신호가 관찰되지 않았다고 보고했습니다. BeiGene은 BeOne Medicines로 이름을 변경할 계획이며, 향후 연구 결과를 공유하여 항-TIGIT 활동에 대한 과학적 이해에 기여할 것입니다. 회사는 혁신적이고 접근 가능한 암 치료법 개발에 집중하고 있습니다.
BeiGene (NASDAQ: ONC) a annoncé l'arrêt de son programme de développement clinique pour ociperlimab (BGB-A1217), un anticorps anti-TIGIT destiné au traitement du cancer du poumon. Cette décision fait suite à une recommandation du Comité Indépendant de Surveillance des Données de mettre fin à l'essai de Phase 3 AdvanTIG-302 en cours après qu'une analyse de futilité pré-planifiée ait indiqué que l'étude était peu susceptible d'atteindre son objectif principal de survie globale.
L'entreprise a signalé qu'aucun nouveau signal de sécurité n'avait été observé pendant l'essai. BeiGene, qui prévoit de changer son nom en BeOne Medicines, partagera les résultats de l'étude à l'avenir pour contribuer à la compréhension scientifique de l'activité anti-TIGIT. L'entreprise reste concentrée sur le développement de traitements innovants et accessibles contre le cancer.
BeiGene (NASDAQ: ONC) gab die Einstellung seines klinischen Entwicklungsprogramms für ociperlimab (BGB-A1217), ein Anti-TIGIT-Antikörper zur Behandlung von Lungenkrebs, bekannt. Die Entscheidung folgt einer Empfehlung des Unabhängigen Datenüberwachungsausschusses, die laufende Phase 3 AdvanTIG-302-Studie zu beenden, nachdem eine vorgeplante Nutzlosigkeitsanalyse ergeben hat, dass die Studie wahrscheinlich ihr primäres Ziel der Gesamtüberlebensrate nicht erreichen wird.
Das Unternehmen berichtete, dass während der Studie keine neuen Sicherheitssignale beobachtet wurden. BeiGene, das plant, seinen Namen in BeOne Medicines zu ändern, wird die Studienergebnisse in Zukunft teilen, um zum wissenschaftlichen Verständnis der Anti-TIGIT-Aktivität beizutragen. Das Unternehmen konzentriert sich weiterhin auf die Entwicklung innovativer und zugänglicher Krebsbehandlungen.
- No new safety concerns identified in the trial
- Phase 3 AdvanTIG-302 trial failed to meet primary endpoint
- Complete discontinuation of ociperlimab development program for lung cancer
- Resources spent on unsuccessful clinical program
The Independent Data Monitoring Committee recommended terminating the ongoing Phase 3 AdvanTIG-302 trial (NCT04746924) based on its findings as part of a pre-planned futility analysis. The overall efficacy and safety data assessment suggested that the study was unlikely to meet the primary endpoint of overall survival. No new safety signals were observed. After thorough deliberation, the Company has made the decision to terminate the trial.
“We evaluate our clinical programs to focus our resources on the most promising clinically differentiated candidates while thoughtfully de-prioritizing others. Our commitment remains steadfast: to discover and develop innovative treatments that are more affordable and accessible to cancer patients worldwide,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “We thank the investigators, their patients, and support staff whose participation and dedication made this research possible.”
Results from this study will be shared at a later date to help advance science and the understanding of anti-TIGIT activity.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeiGene, please visit www.beigene.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of results from the AdvanTIG-302 trial to help advance science and the understanding of anti-TIGIT activity; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the
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Investor Contact
Liza Heapes
+1 857-302-5663
ir@beigene.com
Media Contact
Kyle Blankenship
+1 667-351-5176
media@beigene.com
Source: BeiGene, Ltd.
FAQ
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