Mylan’s breast cancer biosimilar matches Roche’s Herceptin in Phase III trial

pharmafile | June 6, 2016 | News story | Research and Development |  ASCO, Biocon, Herceptin, Mylan, Roche, biosimilar, breast cancer, trastuzumab 

Mylan (NASDAQ: MYL) and Biocon (NSE: BIOCON) have presented data the 2016 American Society of Clinical Oncology (ASCO) annual meeting confirming the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar for Roche’s Herceptin (trastuzumab).

The drug has consistently achieved sales in the billions for Roche, and has been the most dominant breast cancer drug on the market for some time. It is 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.

In the Phase III HERITAGE trial, patients with HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease were given either MYL-1401O or trastuzumab.

Lead study author, Dr Hope S. Rugo, professor of medicine at the University of California, explains: “The HERITAGE study successfully 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.

“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.”

Biocon shares were up 3.26% at the time of writing, while Mylan shares were also up in after-hours trading.

Sean Murray