Shanghai Henlius Biotech and Organon announced on 30 September 2024 that their phase 3 comparative clinical trial for HLX11, an investigational biosimilar to Perjeta (pertuzumab), met its primary endpoint.
Pertuzumab is a monoclonal antibody that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, thereby preventing signalling pathways that promote cell growth and proliferation [1].
In June 2022, Henlius entered into a licensing and supply agreement with Organon, granting Organon exclusive global commercialization rights—excluding China—for two biosimilar candidates: Perjeta (pertuzumab) and Prolia/Xgeva (denosumab) [2].
The Phase 3 clinical study (NCT05346224) evaluated the efficacy and safety of HLX11 compared to reference Perjeta (pertuzumab) as a neoadjuvant therapy for HER2-positive, hormone receptor (HR)-negative early or locally advanced breast cancer. Patients were randomized 1:1 to receive either HLX11 or Perjeta alongside trastuzumab and docetaxel for four cycles.
The trial’s primary endpoint, total pathological complete response (tpCR) rate assessed by an Independent Review Committee, was met. Secondary endpoints under analysis include investigator-assessed tpCR, breast pathological complete response (bpCR), objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), as well as safety, pharmacokinetics, and immunogenicity.
Pertuzumab, in combination with trastuzumab and chemotherapy, is currently approved for neoadjuvant, first-line, and adjuvant treatment of advanced HER2-positive breast cancer. Additionally, the Iranian FDA has approved a pertuzumab follow-on biological for use in Iran [3].
Earlier this year, in April 2024, Henlius Biotech and Organon announced that the Phase III comparative clinical trial for their investigational denosumab biosimilar (HLX14), also met its primary endpoints [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pertuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pertuzumab
2. GaBI Online - Generics and Biosimilars Initiative. Organon–Henlius partnership: biosimilars for women’s health [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/pharma-news/organon-henlius-partnership-biosimilars-for-women-s-health
3. GaBI Online - Generics and Biosimilars Initiative. The journey of Pectuna pertuzumab follow-on biological in Iran [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/pharma-news/the-journey-of-pectuna-pertuzumab-follow-on-biological-in-iran
4. GaBI Online - Generics and Biosimilars Initiative. Unveiling key clinical findings for denosumab biosimilar candidates [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/biosimilars/research/unveiling-key-clinical-findings-for-denosumab-biosimilar-candidates
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