DUALITYBIO-B (09606): Phase III Clinical Trial of DB-1303/BNT323 for HER2-Positive Unresectable or Metastatic Breast Cancer Patients Achieves Primary Endpoint

Stock News

Sep 05

DUALITYBIO-B (09606) announced that following evaluation by the Independent Data Monitoring Committee (IDMC), the Phase III clinical trial of DB-1303/BNT323 for HER2-positive unresectable or metastatic breast cancer patients who previously received trastuzumab and taxane treatment has achieved its primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review (BICR) compared to the control group. Based on these interim analysis results, the company plans to communicate with the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) regarding the submission of a Biologics License Application (BLA) for DB-1303/BNT323. The trial is a randomized, controlled, open-label, multicenter Phase III clinical study conducted in China, designed to evaluate the efficacy and safety of DB-1303 compared to T-DM1 in HER2-positive unresectable or metastatic breast cancer patients who previously received trastuzumab and taxane treatment.

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