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Clinical Trial
. 2024 Oct;24(7):639-646.e2.
doi: 10.1016/j.clbc.2024.07.001. Epub 2024 Jul 10.

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

Rushabh Kothari  1 , Maulik Doshi  2 , P K Chaithanya  3 , Satheesh Ct  4 , Anil Kumar  5 , Krishna Mohan Mallavarapu  6 , Rajnish Nagarkar  7 , Vijay Mahobia  8 , Niraj Bhatt  9 , K L Priyadarshini  10 , Ajay Gogia  11 , Tanveer Maksud  12 , Saurabh Prasad  13 , K Velavan  14 , Rajeev L K  15 , Prakash Ss  16 , Vikas Talreja  17 , Kaushal Kalra  18 , Bhushan Nemade  19 , Aloke Ghosh Dastidar  20 , Tarachand Gupta  21 , Tushar Patil  22 , Shailesh Bondarde  23 , Pinakin Patel  24 , Sudeep Gupta  25 , Ghanashyam Biswas  26 , Manan Vaghela  27 , Pinaki Mahato  28 , Honey Parekh  29 , Mahesh Kalloli  30 , Rachan Shetty  31 , Gaurav Prakash  32 , Anil Goel  33 , Srikrishna Mandal  34 , Tamohan Choudhury  35 , Minish Jain  36 , Chanchal Goswami  37 , Yathish Kumar H M  38 , K K Mukherjee  39 , Rahul Shrivastava  40 , Deven Parmar  41
Affiliations
Clinical Trial

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

Rushabh Kothari et al. Clin Breast Cancer. 2024 Oct.

Abstract

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®.

Keywords: Clinical care; Drug accessibility; Drug affordability; Immunogenicity; Non-inferiority.

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Conflict of interest statement

Disclosure Deven Parmar is an employee of Zydus Therapeutics Inc, USA, whereas Maulik Doshi and Rahul Shrivastava are employees of Zydus Lifesciences Ltd. All other authors declare no conflict of interest.

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