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].

Related articles
Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars

FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.