Shanghai, China & JERSEY CITY, N.J. – September 30, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta® (pertuzumab) 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 (NCT05346224) aimed to compare the efficacy and safety of HLX11 with reference Perjeta® (pertuzumab) 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 (pertuzumab) in combination with trastuzumab and docetaxel every three weeks for four cycles. The primary endpoint of this study was the total pathological complete response (tpCR) rate assessed by Independent Review Committee (IRC). The secondary endpoints currently being analyzed included tpCR rate assessed by investigators, breast pathologic complete response (bpCR) rate, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), 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.
About Organon
Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.
Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.
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