Shanghai Henlius Biotech, Inc. and Organon announced on September 30, 2024, that their investigational Perjeta (pertuzumab) biosimilar candidate, HLX11, met its primary endpoint in a Phase 3 comparative clinical trial. The study evaluated the efficacy and safety of HLX11 as a neoadjuvant therapy for patients with HER2-positive, HR-negative early, or locally advanced breast cancer.
The primary endpoint, total pathological complete response (tpCR) rate assessed by an Independent Review Committee, was successfully achieved. This positive outcome is a significant step for HLX11, which is being developed under a 2022 license and supply agreement granting Organon exclusive global commercialization rights outside of China.
Pertuzumab is approved in various regions for use in combination with trastuzumab and chemotherapy for neoadjuvant and adjuvant treatment of certain HER2-positive breast cancers. The successful Phase 3 trial positions HLX11 for potential future regulatory submissions and market entry, expanding Organon's biosimilars portfolio.
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