Hematology Oncology Department, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Thalassemia and Hemoglobinopathy Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
BMC Cancer. 2022 Sep 7;22(1):960. doi: 10.1186/s12885-022-09895-5.
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.
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.
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.
The proposed biosimilar P013 was equivalent to the reference product in terms of efficacy. The safety of both medications was also comparable.
乳腺癌是最常见的癌症，也是女性癌症相关死亡的主要原因。双 HER2（人表皮生长因子受体 2）阻断的新辅助治疗在这方面显示出了良好的效果。本研究旨在比较一种拟议的曲妥珠单抗生物类似药与参比曲妥珠单抗的疗效和安全性。
这是一项随机、III 期、多中心、等效性临床试验，纳入了未经化疗的 HER2 阳性乳腺癌女性患者。患者按 1:1 比例随机分配（1:1）接受六周期的 P013（CinnaGen，伊朗）或原研产品（Perjeta，罗氏，瑞士）联合曲妥珠单抗、卡铂和多西他赛，每 3 周一次。患者按癌症类型（可手术、局部晚期、炎症）和激素受体状态分层。主要终点是乳腺病理完全缓解（bpCR）。次要终点包括总完全缓解率（pCR）、总缓解率（ORR）、保乳手术（BCS）、安全性和免疫原性的比较。
共有 214 例患者被随机分配至治疗组。在符合方案人群中，P013 组的 bpCR 率为 67.62%，参比药物组为 71.57%。根据 bpCR，P013 与参比曲妥珠单抗等效，平均差值为-0.04（95%CI：-0.16，0.09）。次要终点在两组间也具有可比性。
拟议的生物类似药 P013 在疗效方面与参比产品相当。两种药物的安全性也相当。
