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Clinical Trial
. 2022 Sep 7;22(1):960.
doi: 10.1186/s12885-022-09895-5.

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

Abolghasem Allahyari  1 , Ali Ehsanpour  2 , Behrouz Najafi  3 , Nafiseh Ansarinejad  4 , Valiollah Mehrzad  5 , Behjat Kalantari  6 , Jahangir Raafat  7 , Mojtaba Ghadiany  8 , Farhad Shahi  9 , Behrooz Gharib  10 , Vahid Moazed  11 , Adnan Khosravi  12 , Mir Hossein Mirpour  13 , Sina Salari  14 , Seyedmohammadreza Mortazavizadeh  15 , Amirabbas Nekoyi  16 , Mohsen Khani  17 , Alireza Sadeghi  18 , Sirus Gharib  19 , Alireza Bary  20 , Mehrzad Mirzania  21 , Shirin Haghighat  22 , Seyed Mohsen Razavi  23 , Seyed Amir Hossein Emami  24 , Mehran Hosseinzadeh  25 , Mahdi Mirbolouk  26 , Sanambar Sadighi  27 , Abdolali Shahrasbi  28 , Ali Esfahani  29 , Masoumeh Gity  30 , Nassim Anjidani  31 , Hamidreza Kafi  31 , Safa Najafi  32
Affiliations
Clinical Trial

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

Abolghasem Allahyari et al. BMC Cancer. .

Erratum in

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.

Keywords: Biosimilar; Breast Cancer; Equivalency; Pertuzumab; Randomized clinical trial.

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Conflict of interest statement

Nassim Anjidani is the head of the medical department of Orchid Pharmed Company, which is in collaboration with CinnaGen Company with respect to conducting clinical trials. Hamidreza Kafi is head of advisory board in Orchid Pharmed Company. No other potential conflicts of interest relevant to this article were reported.

Figures

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Fig. 1
Patient disposition
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Fig. 2
Absolute left ventricular ejection fraction (LVEF) change form baseline during treatment
See this image and copyright information in PMC

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