印度一项随机、双盲、III 期研究,比较 ZRC-3277(培妥珠单抗生物类似物)与 Perjeta® 在 HER2 阳性转移性乳腺癌患者中的疗效、安全性和 PK 值

IF 2.9 3区 医学 Q2 ONCOLOGY
Rushabh Kothari , Maulik Doshi , P.K. Chaithanya , Satheesh CT , Anil Kumar , Krishna Mohan Mallavarapu , Rajnish Nagarkar , Vijay Mahobia , Niraj Bhatt , K.L. Priyadarshini , Ajay Gogia , Tanveer Maksud , Saurabh Prasad , K. Velavan , Rajeev L․K․ , Prakash SS , Vikas Talreja , Kaushal Kalra , Bhushan Nemade , Aloke Ghosh Dastidar , Deven Parmar
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引用次数: 0

摘要

引言目的评估 ZRC-3277(培妥珠单抗生物类似药)与 Perjeta®(培妥珠单抗)在既往未经治疗的人表皮生长因子受体 2 (HER2) 阳性转移性乳腺癌 (MBC) 患者中的疗效、安全性、药代动力学 (PK) 和免疫原性。患者和方法这项III期多中心双盲研究在印度的38个研究机构进行,将HER2阳性MBC患者随机(1:1)分为ZRC-3277组或Perjeta®组。两组患者均接受曲妥珠单抗和多西他赛治疗。在268名注册患者中,mITT人群有243名(ZRC-3277组和Perjeta®组分别有119名和124名)。主要目的是比较治疗 6 个周期后组间客观反应率 (ORR)。ORR是根据实体瘤反应评估标准(RECIST 1.1)评估计算机断层扫描或磁共振成像扫描结果确定的。确定ORR差异的双侧95%置信区间(95% CI),以评估ZRC-3277与Perjeta®的非劣效性。结果在mITT人群中,ZRC-3277组和Perjeta®组分别有104人(87.39%)和114人(91.94%)达到ORR。在预定义的-15%非劣效边际下,两组间ORR差异(-4.55%)的双侧95% CI(-12.19%,3.11%)表明ZRC-3277的非劣效性优于Perjeta®。结论ZRC-3277的疗效、PK、免疫原性和安全性与Perjeta®相似。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Randomized, Double-Blind, Phase III Study in India for Comparing Efficacy, Safety, and PK of ZRC-3277 (Pertuzumab Biosimilar) With Perjeta® in Patients With HER2-Positive Metastatic Breast Cancer

Introduction

To evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of ZRC-3277 (pertuzumab biosimilar) with Perjeta® (pertuzumab) in previously untreated patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Patients and Methods

This phase III, multicenter, double-blind study across 38 sites in India randomized (1:1) patients with HER2-positive MBC in either the ZRC-3277 or Perjeta® group. Both groups also received trastuzumab and docetaxel. Of 268 enrolled patients, mITT population had 243 patients (119 and 124 in the ZRC-3277 and Perjeta® groups, respectively). The primary objective was to compare the between-group objective response rate (ORR) after 6 cycles of treatment. ORR was determined by evaluating scans of computed tomography or magnetic resonance imaging following Response Evaluation Criteria in Solid Tumor (RECIST 1.1). Two-sided 95% confidence interval (95% CI) for the difference in ORR was determined to evaluate the noninferiority of ZRC-3277 to Perjeta®. The secondary outcomes included the assessment of PK, immunogenicity, and safety between the 2 groups.

Results

In the mITT population, 104 (87.39%) and 114 (91.94%) participants achieved the ORR in the ZRC-3277 and Perjeta® groups, respectively. For predefined -15% noninferiority margin, obtained 2-sided 95% CIs (−12.19%, 3.11%) for the difference in ORR (−4.55%) between the 2 groups demonstrated the noninferiority of ZRC-3277 to Perjeta®. PK, immunogenicity, and safety were not significantly different between the 2 groups.

Conclusion

Efficacy, PK, immunogenicity, and safety profiles of ZRC-3277 was found to be similar to those of Perjeta®.

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来源期刊
Clinical breast cancer
Clinical breast cancer 医学-肿瘤学
CiteScore
5.40
自引率
3.20%
发文量
174
审稿时长
48 days
期刊介绍: Clinical Breast Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of breast cancer. Clinical Breast Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of breast cancer. The main emphasis is on recent scientific developments in all areas related to breast cancer. Specific areas of interest include clinical research reports from various therapeutic modalities, cancer genetics, drug sensitivity and resistance, novel imaging, tumor genomics, biomarkers, and chemoprevention strategies.
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