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BioNTech Breast Cancer ADC Meets Phase 3 Goal in China Interim Analysis

The readout is the first Phase‑III success from its DualityBio partnership, positioning a global trial to generate data for US and EU submissions.

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Der Wirkstoff verbessert die Überlebenszeit bei fortgeschrittenem Brustkrebs.

Overview

  • An interim analysis found Trastuzumab Pamirtecan (BNT323) significantly prolonged progression‑free survival versus an approved therapy in advanced breast cancer.
  • The pivotal study is being run in China and remains ongoing, with regulatory decisions contingent on full data and subsequent review.
  • BioNTech has already launched a second global Phase‑III study intended to support potential filings in the United States and European Union.
  • BNT323 is an antibody–drug conjugate designed to deliver a chemotherapeutic payload directly to tumor cells to help limit damage to healthy tissue.
  • The result marks the first Phase‑III milestone from BioNTech’s collaboration with DualityBio, and the company is also testing combinations, including with bispecific antibody BNT327.