On December 27, 2016 Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported that the results of the HERITAGE study have been published in the Journal of the American Medical Association (JAMA) (Press release, Mylan, DEC 27, 2016, View Source [SID1234517207]). Study results confirm the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Mylan and Biocon, in comparison to branded trastuzumab. The results of the trial were first presented at this year’s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. Branded trastuzumab is indicated to treat certain HER2-positive breast and gastric cancers. Schedule your 30 min Free 1stOncology Demo! Dr. Hope S. Rugo, professor of medicine at the University of California, San Francisco, commented: "We are encouraged by the confirmatory efficacy and safety results of the HERITAGE study recently published in JAMA. This study was the last major step of a multiple-phased program to demonstrate that proposed biosimilar trastuzumab meets the criteria for equivalence in comparison to branded trastuzumab. Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab. Tumor progression, progression-free survival and overall survival was not statistically different between proposed biosimilar trastuzumab and branded trastuzumab at week 48."
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Mylan President Rajiv Malik added: "We are proud that JAMA has recognized the results of the HERITAGE study and are encouraged that the proposed biosimilar trastuzumab, MYL-1401O, could provide an effective treatment option for metastatic breast cancer patients. Phase 3 study results show that a biosimilar can deliver similar efficacy in comparison to a branded product. Once approved, we believe our proposed biosimilar trastuzumab will provide a lower cost treatment option for breast cancer patients. We look forward to continuing our industry-leading role with Biocon to expand patient access across the globe to this critically important medicine as well as Mylan’s broad portfolio of 15 additional biologics and insulin analogs currently in development."
Dr. Narendra Chirmule, Sr. Vice President & Head R&D, Biocon, said: "The development of biosimilars requires a systematic scientific approach from design of the process to development. Biocon and Mylan have a scientifically rigorous, ethically compliant and structured development strategy to establish comparative safety and efficacy of our products. The global clinical progress of our various biosimilars programs demonstrates the strength of our R&D capabilities in this area. We are pleased that JAMA has published the clinical study results of trastuzumab after its very rigorous peer review process."
The HERITAGE data was submitted by Mylan to the U.S. Food and Drug Administration (FDA) as part of the biologics license application (BLA) for MYL-1401O last month.
The full study, "Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Randomized Clinical Trial," can be accessed on JAMA’s website: View Source
Dr. Rugo is an independent consultant for Mylan. She serves as the Chair of the Steering Committee for the HERITAGE Study and does not receive compensation from Mylan.
About the HERITAGE Study
HERITAGE is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the proposed trastuzumab biosimilar, MYL-1401O, versus branded trastuzumab. Eligible patients had centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. Patients were randomized to receive either MYL-1401O or branded trastuzumab with docetaxel or paclitaxel for a minimum of eight cycles. Trastuzumab was continued until progression. The primary endpoint is overall response at week 24 by blinded central evaluation using RECIST 1.1. Secondary endpoints include safety and progression free survival, overall survival at 48 weeks. A sample size of 456 patients was calculated to demonstrate equivalence in overall response at week 24 for MYL-1401O versus branded trastuzumab, defined as a 90% confidence interval for the ratio of best overall response within the equivalence margin (0.81, 1.24).
About the Biocon and Mylan Partnership
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.