Date: 2016-12-27
Type of information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in The Journal of the American Medical Directors Association
Company: Mylan (USA - PA) Biocon (India)
Product: MYL-1401O - biosimilar version of trastuzumab
Action
mechanism: biosimilar/monoclonal antibody.
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country: Brazil, Chile, Georgia, Hungary, India, Latvia, Peru, Romania, Russian Federation, Serbia, Slovakia, South Africa, Thailand, Turkey, Ukraine
Trial
details: 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 progression free survival, overall survival, and safety. 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). (NCT02472964)
Latest
news: On December 27, 2016, Mylan announced that the results of the HERITAGE study have been published in the Journal of the American Medical Association ( JAMA). 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) Annual Meeting and the European Society for Medical Oncology (ESMO) Congress. Branded trastuzumab is indicated to treat certain HER2-positive breast and gastric cancers. * On June 3, 2016, Mylan and Biocon announced the presentation of data from the HERITAGE study at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago , June 3-7 . The study confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison to branded trastuzumab. Trastuzumab is indicated for the treatment of HER2-positive metastatic breast cancer patients. It is also indicated for adjuvant treatment of HER2 overexpressing breast cancer and metastatic gastric cancer. It is a targeted therapy that interferes with the HER2 protein and impedes cancer cell growth.
The HERITAGE data was submitted by Mylan to the FDA as part of the biologics license application (BLA) for MYL-1401O last month.
The HERITAGE study met the predefined endpoints of response equivalency.The response rates at 24 weeks were 69.6% with MYL-1401O combined with taxane chemotherapy versus 64% with branded trastuzumab combined with the same chemotherapy agent. Safety was comparable between treatment groups. The rates of serious adverse events were 38% with MYL-1401O and 36% with branded trastuzumab.
Details of the sessions as on the ASCO website are as follows:
A pharmacokinetics (PK) bioequivalence trial of proposed trastuzumab biosimilar Myl-1401O (A) vs EU-Herceptin® (B) and US-Herceptin® (C)" (poster#71 - Presenter: Cornelius F. Waller , MD, University of Freiburg Medical Center and HERITAGE: A phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus Herceptin®".
