Organon, Henlius announce Phase 3 study of HLX11 met primary endpoint

Shanghai Henlius Biotech and Organon announced that the phase 3 comparative clinical trial for the investigational Perjeta biosimilar HLX11 met the primary endpoint. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement licenses the global commercialization rights for the product, except for China, to Organon. The multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study aimed to compare the efficacy and safety of HLX11 with reference Perjeta as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. Eligible patients were randomized 1:1 to receive either HLX11 or reference Perjeta in combination with trastuzumab and docetaxel every three weeks for four cycles. The primary endpoint of this study was the total pathological complete response rate assessed by Independent Review Committee. The secondary endpoints currently being analyzed included tpCR rate assessed by investigators, breast pathologic complete response rate, objective response rate, event-free survival, disease-free survival, safety, pharmacokinetics, and immunogenicity. The primary endpoint of this study was met. Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant, first-line, and adjuvant treatment for certain advanced HER2-positive breast cancer.