The journey of Pectuna pertuzumab follow-on biological in Iran

Pertuzumab is a monoclonal antibody (mAb) that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation. It is a pivotal therapeutic in oncology, targeting the overexpressed HER2 protein, particularly in breast cancer [1].

Roche/Genentech's Perjeta, the originator product, secured Food and Drug Administration (FDA) approval in June 2012 and European Medicines Agency (EMA) approval in March 2013, demonstrating efficacy in HER2-positive breast cancer when used in combination with trastuzumab and chemotherapy, significantly impacting patient outcomes [2].

In 2012, a phase III clinical trial (CLEOPATRA) assessed the safety and efficacy of docetaxel and trastuzumab plus pertuzumab, as compared to a placebo as first line treatment in HER2+ metastatic breast cancer patients. In this study, 808 patients in 204 centres were treated and the median of Progressive Free Survival (PFS) in the pertuzumab arm showed 6.1 months’ improvement in PFS compared to the placebo arm. Furthermore, in this study, the ratio of treatment response in the pertuzumab arm showed 10.8% improvement compared to the placebo arm and reached to 80.2% [3].

The marketing exclusivity on Perjeta will expire in the US in June 2024 and expired in Europe in March 2023, there are several pertuzumab biosimilars and non-originator biologicals in development. CinnaGen, a leading biotechnology company in Iran, has achieved a significant milestone with Pectuna, a follow-on biological of pertuzumab [4].

Established in 1994, CinnaGen stands as the largest biotechnology company in Iran [5] and has grown to become the biggest biopharmaceutical manufacturer and biotech exporter in the Middle East and North Africa region.

The company embarked on producing a pertuzumab biosimilar in response to the high price of the originator antibody and its unavailability on the Iranian drug list.

Between 2018‒2020, CinnaGen carried out a phase III trial that was randomized, double-arm, and triple-blind. The trial aimed to assess the efficacy equivalence of CinnaGen's Pectuna, compared to the reference drug Perjeta in neoadjuvant treatment for HER2+ breast cancer patients. With a 1:1 ratio, 214 patients were enrolled, and the primary endpoint was pathological complete response (pCR) in the breast. The study results demonstrated the equivalence of Pectuna and Perjeta in terms of efficacy and safety, with no significant differences noted. Secondary endpoints, including clinical response rate (CRR), total pathological complete response (tpCR), further supported the biosimilarity of Pectuna to Perjeta [6, 7].

The phase III trial's comprehensive evaluation, coupled with the phase I findings, presented Pectuna as a biosimilar of Perjeta, providing clinicians and patients with an alternative treatment option for HER2+ breast cancer.

These milestones highlight CinnaGen's commitment to scientific innovation and the development of biosimilars that hold promise for enhanced accessibility and affordability in cancer therapeutics.

Pectuna is a pertuzumab follow-on biological exclusively available in Iran and approved by the Iranian FDA. Its development marks a pioneering step in advancing cancer treatment options in the country [5].

Organon–Henlius partnership: biosimilars for women’s health

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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 Feb 29]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pertuzumab
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. Swain SM, Miles D, Kim S-B, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21(4):519-30.
4. CinnaGen. Pectuna® [homepage on the Internet]. [cited 2024 Feb 29]. Available from: https://www.cinnagen.com/Product.aspx?t=2&l=1&Id=619
5. GaBI Online - Generics and Biosimilar Initiative. CinnaGen to invest in Turkish pharmaceuticals sector [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 29]. Available from:
www.gabionline.net/pharma-news/CinnaGen-to-invest-in-Turkish-pharmaceuticals-sector
6. ClinicalTrials.gov. Comparing efficacy and safety between Pertuzumab® and Perjeta® in neoadjuvant treatment of HER2+ breast cancer [homepage on the Internet]. [cited 2024 Feb 29]. Available from:
https://clinicaltrials.gov/study/NCT04957212
7. Comparing efficacy and safety of P013, a proposed pertuzumab biosimilar, with the reference product in HER2-positive breast cancer patients: a randomized, phase III, equivalency clinical trial. BMC Cancer. 2022;22(1):960. doi: 10.1186/s12885-022-09895-5. Erratum in: BMC Cancer. 2022 Dec 22;22(1):1348. PMID: 36071409; PMCID: PMC9450379. https://bmccancer.biomedcentral.com/articles/10.1186/s12885-022-09895-5

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