NDLI: 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

Content Provider	Springer Nature : BioMed Central
Author	Allahyari, Abolghasem Ehsanpour, Ali Najafi, Behrouz Ansarinejad, Nafiseh Mehrzad, Valiollah Kalantari, Behjat Raafat, Jahangir Ghadiany, Mojtaba Shahi, Farhad Gharib, Behrooz Moazed, Vahid Khosravi, Adnan Mirpour, Mir Hossein Salari, Sina Mortazavizadeh, Seyedmohammadreza Nekoyi, Amirabbas Khani, Mohsen Sadeghi, Alireza Gharib, Sirus Bary, Alireza Mirzania, Mehrzad Haghighat, Shirin Razavi, Seyed Mohsen Emami, Seyed Amir Hossein Hosseinzadeh, Mehran Mirbolouk, Mahdi Sadighi, Sanambar Shahrasbi, Abdolali Esfahani, Ali Gity, Masoumeh Anjidani, Nassim Kafi, Hamidreza Najafi, Safa
Abstract	Background Breast cancer is the most frequently diagnosed cancer and the leading reason for cancer-related death among women. Neoadjuvant treatment with dual-HER2 (human epidermal growth factor receptor 2) blockade has shown promising effects in this regard. The present study aimed to compare the efficacy and safety of a proposed pertuzumab biosimilar with the reference pertuzumab. Methods This randomized, phase III, multicenter, equivalency clinical trial was conducted on chemotherapy-naive women with HER2-positive breast cancer. Patients were randomly assigned (1:1) to receive six cycles of either P013 (CinnaGen, Iran) or the originator product (Perjeta, Roche, Switzerland) along with trastuzumab, carboplatin, and docetaxel every 3 weeks. Patients were stratified by cancer type (operable, locally advanced, inflammatory) and hormone receptor status. The primary endpoint was breast pathologic complete response (bpCR). Secondary endpoints included comparisons of total pCR, overall response rate (ORR), breast-conserving surgery (BCS), safety, and immunogenicity. Results Two hundred fourteen patients were randomized to treatment groups. bpCR rate in the per-protocol population was 67.62% in the P013 and 71.57% in the reference drug groups. Based on bpCR, P013 was equivalent to the reference pertuzumab with a mean difference of − 0.04 (95% CI: − 0.16, 0.09). Secondary endpoints were also comparable between the two groups. Conclusions The proposed biosimilar P013 was equivalent to the reference product in terms of efficacy. The safety of both medications was also comparable.
Related Links	https://bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-022-09895-5.pdf
Ending Page	10
Page Count	10
Starting Page	1
File Format	HTM / HTML
ISSN	14712407
DOI	10.1186/s12885-022-09895-5
Journal	BMC Cancer
Issue Number	1
Volume Number	22
Language	English
Publisher	BioMed Central
Publisher Date	2022-09-07
Access Restriction	Open
Subject Keyword	Cancer Research Oncology Surgical Oncology Health Promotion and Disease Prevention Biomedicine Medicine Public Health Breast Cancer Pertuzumab Biosimilar Equivalency Randomized clinical trial Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Cancer Research Oncology Genetics
Journal Impact Factor	3.4/2023
5-Year Journal Impact Factor	3.8/2023

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