On May 15, 2019 Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported that final data from the HERITAGE study will be presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Mylan, MAY 15, 2019, View Source [SID1234536368]). The HERITAGE study compared Ogivri to the reference product, Herceptin, in patients with HER2+ metastatic breast cancer in combination with taxanes for the first 24 weeks and then as a monotherapy until progression. Safety and overall survival, cumulative through 36 months of follow-up, will be presented as part of the Breast Cancer – Metastatic session, "HER2-Positive Disease: How Far Have We Come?," on June 2.

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Mylan Head of Global Biologics, R&D, Arnd Annweiler, commented: "We’re pleased with the final results of the landmark HERITAGE study which further validate the safety and efficacy profile of Ogivri and confirm that no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. We have long been committed to the science and clinical data behind this important treatment and are proud to reach this milestone. Today, we continue on our mission to increase access to Ogivri and the additional biosimilars in our pipeline for patients around the world. We’re grateful for ASCO (Free ASCO Whitepaper)’s recognition of this critical study over the past years and the important role they have played in educating and instilling confidence in healthcare providers and patients about the safety, efficacy and value of biosimilars."

Christiane Hamacher, CEO, Biocon Biologics, said: "The final safety and overall survival data from the HERITAGE study for our biosimilar trastuzumab, Ogivri, cumulative through 36 months of follow up, reconfirms that efficacy and safety is very similar to the reference product, Herceptin. The presentation of this data at ASCO (Free ASCO Whitepaper) will enable a wider adoption of our biosimilar trastuzumab which has so far benefited thousands of patients across the globe. Biocon Biologics is committed to enable access to this high quality affordable therapy for HER2-positive breast and gastric cancer patients as we strive to co-create a healthy future."

Following are the session details:

Abstract 1021: Biosimilar trastuzumab-dkst monotherapy versus trastuzumab monotherapy after combination therapy: Final overall survival (OS) from the phase III HERITAGE Trial
Date: June 2, 2019
Poster display: #102, 8-11 a.m. CDT, Hall A
Poster discussion: 11:15 a.m.-12:45 p.m. CDT, Hall D2
Session: Breast Cancer – Metastatic
Presenter: Dr. Cornelius Waller, Department of Haematology, Oncology and Stem Cell Transplantation, University Medical Centre Freiburg and Faculty of Medicine, University of Freiburg, Freiburg, Germany
Mylan and Biocon’s biosimilar for Herceptin has received regulatory approval in more than 65 countries worldwide.

About the HERITAGE Study
HERITAGE is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the trastuzumab biosimilar trastuzumab-dkst (formerly known as 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 trastuzumab-dkst 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 trastuzumab-dkst versus branded trastuzumab, defined as a 90% confidence interval for the ratio of best overall response within the equivalence margin (0.81, 1.24).The primary endpoint has previously been reported: the overall response rate in patients with HER2-positive metastatic breast cancer at week 24 was equivalent between the trastuzumab-dkst and trastuzumab groups (Rugo et al. JAMA. 2017;317:37-47).