BeiGene Provides Update on the Ociperlimab (BGB-A1217) Clinical Development Program
Apr 03, 2025 6:00 AM
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
Results from this study will be shared at a later date to help advance science and the understanding of anti-TIGIT activity.
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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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