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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
Authors
  1. Allahyari A1
  2. Ehsanpour A2
  3. Ansarinejad N3
  4. Mehrzad V4
  5. Kalantari B5
  6. Raafat J6
  7. Ghadiany M7
  8. Shahi F8
  9. Gharib B9
  10. Moazed V10
  11. Khosravi A11
  12. Mirpour MH12
  13. Salari S13
  14. Mortazavizadeh S14
  15. Nekoyi A15
  16. Khani M16
  17. Sadeghi A17
  18. Gharib S18
  19. Bary A19
  20. Mirzania M20
  21. Haghighat S21
  22. Razavi SM22
  23. Emami SAH23
  24. Hosseinzadeh M24
  25. Mirbolouk M25
  26. Sadighi S26
  27. Shahrasbi A27
  28. Esfahani A28
  29. Gity M29
  30. Anjidani N30
  31. Kafi H30
  32. Najafi S31
Show Affiliations
Authors Affiliations
  1. 1. Hematology Oncology Department, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
  2. 2. Thalassemia and Hemoglobinopathy Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
  3. 3. Department of Hematology & Oncology, Iran University of Medical Sciences, Tehran, Iran
  4. 4. Hematology and Oncology Department, Isfahan Medical School, Isfahan, Iran
  5. 5. Hematology & Oncology, Department of Internal Medicine, School of Medicine, Shahid Bahonar Hospital, Kerman University of Medical Sciences, Kerman, Iran
  6. 6. Mehrad Hospital, Tehran, Iran
  7. 7. Department of Hematology and Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  8. 8. Department of Hematology and Medical Oncology, Breast Disease Research Center, Cancer Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, TUMS, Tehran, Iran
  9. 9. Department of Medical Oncology & Hematology, Naft Hospital, Tehran, Iran
  10. 10. Hematology & Oncology Kerman University of Medical Sciences, Kerman, Iran
  11. 11. Hematology & Oncology, Department of Adult Hematology & Oncology, School of Medicine, Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Dr. Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  12. 12. Medical Oncology Guilan University of Medical Sciences, Razi Hospital, Fuman, Iran
  13. 13. Medical Oncology, Hematology Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  14. 14. Hematology/Oncology Yazd Azad University, Yazd, Iran
  15. 15. Department of Hematology and Medical Oncology, Seyyed-al-shohada Hospital, Esfahan University of Medical Sciences, Tehran, Iran
  16. 16. Medicine Saba Oncology Clinic, Isfahan, Iran
  17. 17. Department of Hematology-Oncology, Isfahan University of Medical Sciences, Isfahan, Iran
  18. 18. Hematology, Oncology Department of Internal Medicine, Guilan University of Medical Sciences, Guilan, Iran
  19. 19. Department of Hematology & Oncology, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
  20. 20. Department of Hematology and Medical Oncology, Cancer Research Center, Cancer Institute of Iran, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
  21. 21. Hematology Research Center, Hematology and Medical Oncology Department, Shiraz University of Medical Sciences, Shiraz, Iran
  22. 22. Iran Medical Science University, Tehran, Iran
  23. 23. Medical Oncology, Cancer Institute, Imam Khomeini Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
  24. 24. Hematology, Oncology Department of Internal Medicine, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
  25. 25. Hazrat Rasol Hospital Rasht, Gilan, Iran
  26. 26. Internal Medicine Group TUMS Faculty of Cancer Institute of Iran, Tehran, Iran
  27. 27. Bouali Hospital, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran
  28. 28. Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
  29. 29. Advanced Diagnostic and Interventional Radiology Research Center, Breast Disease Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
  30. 30. Medical Department, Orchid Pharmed Company, Tehran, Iran
  31. 31. Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran

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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