- Mylan has released top-line results from a phase 3 trial evaluating a biosimilar version of Roche's Herceptin (trastuzumab), which is indicated for treatment of HER2+ breast cancer (and also used to treat HER2-positive stomach cancer in certain cases). The drug, MYL-14010, was tested in 500 women globally but not in the U.S.
- MYL-14010 demonstrated comparable efficacy and safety based on a 24-week assessment of the women in the study. The overall response rate for MYL-14010 versus Herceptin at 24 weeks was 69.6% versus 64% for trastuzumab.
- There has not been one biosimilar approved in the EU or the U.S. for a biologic to treat cancer.
There are 1.7 million women in the world with breast cancer, and of those women 25% have HER2+ breast cancer. The approval of Herceptin in 1998 heralded a major advance in personalized medicine in oncology and shifted the treatment paradigm in breast cancer. Addition of Herceptin to standard chemotherapy regimens in women with advanced disease increases life expectancy by five to eight months.
For patients with early-stage disease, addition of Herceptin decreases risk of recurrence by at least 10%, while also improving survival by 9%.
Efficacy was comparable as was safety---there were severe adverse events in 36% of Herceptin-treated patients versus 38% of MYL-14010-treated patients.
In a statement released by ASCO, Hope S. Rugo, MD, a Professor of Medicine at the University of California San Francisco, said: “Trastuzumab has markedly improved survival of women with HER2-positive breast cancer, but many women around the world can’t benefit from trastuzumab due to its high cost. We hope that the introduction of biosimilars will expand patient access to this effective drug, which has already benefited the lives of thousands of people across the globe.”