On June 3, 2016 Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported the presentation of data from the HERITAGE study at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 3-7 (Press release, Mylan, JUN 3, 2016, View Source [SID:1234512980]). 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.

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"As one of the first companies in the industry to successfully complete a confirmatory efficacy and safety study comparing a proposed biosimilar to a branded cancer drug, this is a significant milestone for Mylan’s biosimilar program," Mylan President Rajiv Malik said. "There is an urgent, unmet need for more affordable versions of biologic products and through our collaboration with Biocon we are well-positioned to be at the forefront to help deliver these complex products to patients around the world. We’re pleased that ASCO (Free ASCO Whitepaper) has recognized the importance of biosimilars in advancing cancer care and the significant role they will play in providing patients greater access to affordable treatment."

Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon, added: "The positive outcomes of the global Phase 3 clinical study with our proposed biosimilar trastuzumab for HER2-positive breast cancer patients are a significant milestone in our joint biosimilars development program with Mylan. The trial will enable regulatory filings of our product in the developed markets. Biocon remains committed to develop affordable biologics and these study results will help us in enhancing access for cancer patients, caregivers and healthcare systems across the globe."

Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. HER2-positive metastatic breast cancer is an aggressive form of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2), which promotes cancer cell growth. Approximately 20% to 30% of primary breast cancers are HER2-positive.

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 study successfully met the predefined endpoints of response equivalency. We are proud of this international collaboration which puts us one step closer to approval of this proposed biosimilar. 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. The ratio of overall response and difference in overall response fell within a narrow, pre-defined equivalence margin suggesting equal efficacy of both products. Safety was comparable between treatment groups. The rates of serious adverse events were 38% with MYL-1401O and 36% with branded trastuzumab, and there was no difference in cardiac safety," commented lead study author Dr. Hope S. Rugo, professor of Medicine at the University of California, San Francisco.

Details of the sessions as on the ASCO (Free ASCO Whitepaper) website are as follows:
"Abstract 583: A pharmacokinetics (PK) bioequivalence trial of proposed trastuzumab biosimilar Myl-1401O (A) vs EU-Herceptin (B) and US-Herceptin ©"
June 5, 8-11 a.m. CDT (Poster Session)
Poster #71
Presenter: Cornelius F. Waller, MD, University of Freiburg Medical Center
Location: Hall A
Link to abstract on the ASCO (Free ASCO Whitepaper) website: View Source

"Abstract LBA503: HERITAGE: A phase III safety and efficacy trial of the proposed trastuzumab biosimilar Myl-1401O versus Herceptin"
June 6, 2:15-2:27 p.m. CDT (Oral Abstract Session)
Presenter: Hope S. Rugo, MD, University of California, San Francisco
Location: Hall D1
Link to abstract on the ASCO (Free ASCO Whitepaper) website: View Source
The abstract for the HERITAGE study has also been selected for the Best of ASCO (Free ASCO Whitepaper) program this summer which will include several meetings across the globe.
Full session details and abstracts for the 2016 Annual Meeting can be found on the ASCO (Free ASCO Whitepaper) website at am.asco.org.

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 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).

About Biosimilars
A biosimilar medicine is a biological medicine that is developed to be similar to an existing biological medicine and has demonstrated no clinically meaningful differences in safety, purity, and potency compared to that of the reference biologic. A biosimilar product and its reference biologic product are expected to have the same safety and efficacy profile and are generally used to treat the same conditions. Biosimilars may offer a less-costly alternative to existing biological medicinal products that have lost their exclusivity rights.