Mylan, Biocon report success with Phase 3 Trastuzumab biosimilar cancer drug trials

Mylan NV and Biocon Ltd have announced the successful presentation of data from the Phase 3 trials which confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison to Rosche's branded trastuzumab.

The companies presented data from `HERITAGE' clinical research study at the 2016 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, 3-7 June, Biocon said in a statement.

''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 programme,'' 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 has recognised 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 per cent to 30 per cent 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.

Biocon said the HERITAGE study successfully met the predefined endpoints of response equivalency, adding that the international collaboration puts the proposed biosimilar one step closer to approval.

''The response rates at 24 weeks were 69.6 per cent with MYL-1401O combined with taxane chemotherapy versus 64 per cent 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 per cent with MYL-1401O and 36 per cent 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.