Shanghai Henlius Biotech, Inc. and Organon announced positive topline results from a Phase 3 comparative clinical trial evaluating HLX11, an investigational biosimilar of Perjeta® (pertuzumab). The study met its primary endpoint, demonstrating comparable efficacy and safety to reference pertuzumab in patients with HER2-positive, HR-negative early or locally advanced breast cancer.
The multicenter, randomized, double-blind, parallel-controlled Phase 3 trial (NCT05346224) enrolled patients who were randomized 1:1 to receive either HLX11 or reference pertuzumab, in combination with trastuzumab and docetaxel, administered every three weeks for four cycles as neoadjuvant therapy. The primary endpoint was the total pathological complete response (tpCR) rate, assessed by an Independent Review Committee (IRC).
Secondary endpoints under analysis include 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. Detailed data from these secondary endpoints will provide a more comprehensive understanding of HLX11's clinical profile.
Pertuzumab, in combination with trastuzumab and chemotherapy, is an established treatment for HER2-positive breast cancer in the neoadjuvant, first-line, and adjuvant settings. Biosimilars like HLX11 have the potential to increase access to these therapies by offering more affordable alternatives.
"The successful outcome of this Phase 3 trial for HLX11 underscores our commitment to developing high-quality biosimilars that can benefit patients worldwide," stated a representative from Henlius. Organon, holding the exclusive commercialization rights to HLX11 outside of China, anticipates leveraging its global footprint to bring this biosimilar to market, pending regulatory approvals.
Henlius has an integrated biopharmaceutical platform with core capabilities throughout the product lifecycle, including R&D, manufacturing, and commercialization. Organon focuses on women’s health, biosimilars, and established medicines, with a global presence and commercial capabilities.
