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

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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 Publisher Pubmed

Allahyari A¹ ; Ehsanpour A² ; Ansarinejad N³ ; Mehrzad V⁴ ; Kalantari B⁵ ; Raafat J⁶ ; Ghadiany M⁷ ; Shahi F⁸ ; Gharib B⁹ ; Moazed V¹⁰ ; Khosravi A¹¹ ; Mirpour MH¹² ; Salari S¹³ ; Mortazavizadeh S¹⁴ Show All Authors

Allahyari A¹
Ehsanpour A²
Ansarinejad N³
Mehrzad V⁴
Kalantari B⁵
Raafat J⁶
Ghadiany M⁷
Shahi F⁸
Gharib B⁹
Moazed V¹⁰
Khosravi A¹¹
Mirpour MH¹²
Salari S¹³
Mortazavizadeh S¹⁴
Nekoyi A¹⁵
Khani M¹⁶
Sadeghi A¹⁷
Gharib S¹⁸
Bary A¹⁹
Mirzania M²⁰
Haghighat S²¹
Razavi SM²²
Emami SAH²³
Hosseinzadeh M²⁴
Mirbolouk M²⁵
Sadighi S²⁶
Shahrasbi A²⁷
Esfahani A²⁸
Gity M²⁹
Anjidani N³⁰
Kafi H³⁰
Najafi S³¹

Source: BMC Cancer Published:2022

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. © 2022, The Author(s).

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Style	Citing Format
MLA	Allahyari A, et al.. "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, vol. 22, no. 1, 2022, pp. -.
APA	Allahyari A, Ehsanpour A, Ansarinejad N, Mehrzad V, Kalantari B, Raafat J, Ghadiany M, Shahi F, Gharib B, Moazed V, Khosravi A, Mirpour MH, Salari S, Mortazavizadeh S, Nekoyi A, Khani M, Sadeghi A, Gharib S, Bary A, ... Najafi S (2022). 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, 22(1), -.
Chicago	Allahyari A, Ehsanpour A, Ansarinejad N, Mehrzad V, Kalantari B, Raafat J, Ghadiany M, et al.. "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 22, no. 1 (2022): -.
Harvard	Allahyari A et al. (2022) '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, 22(1), pp. -.
Vancouver	Allahyari A, Ehsanpour A, Ansarinejad N, Mehrzad V, Kalantari B, Raafat J, et al.. 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):-.
BibTex	@article{ author = {Allahyari A and Ehsanpour A and Ansarinejad N and Mehrzad V and Kalantari B and Raafat J and Ghadiany M and Shahi F and Gharib B and Moazed V and Khosravi A and Mirpour MH and Salari S and Mortazavizadeh S and Nekoyi A and Khani M and Sadeghi A and Gharib S and Bary A and Mirzania M and Haghighat S and Razavi SM and Emami SAH and Hosseinzadeh M and Mirbolouk M and Sadighi S and Shahrasbi A and Esfahani A and Gity M and Anjidani N and Kafi H and Najafi S}, title = {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}, journal = {BMC Cancer}, volume = {22}, number = {1}, pages = {-}, year = {2022} }
RIS	TY - JOUR AU - Allahyari A AU - Ehsanpour A AU - Ansarinejad N AU - Mehrzad V AU - Kalantari B AU - Raafat J AU - Ghadiany M AU - Shahi F AU - Gharib B AU - Moazed V AU - Khosravi A AU - Mirpour MH AU - Salari S AU - Mortazavizadeh S AU - Nekoyi A AU - Khani M AU - Sadeghi A AU - Gharib S AU - Bary A AU - Mirzania M AU - Haghighat S AU - Razavi SM AU - Emami SAH AU - Hosseinzadeh M AU - Mirbolouk M AU - Sadighi S AU - Shahrasbi A AU - Esfahani A AU - Gity M AU - Anjidani N AU - Kafi H AU - Najafi S TI - 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 JO - BMC Cancer VL - 22 IS - 1 SP - EP - PY - 2022 ER -