CHICAGO – Dr. Hope Rugo presented results from a phase III trial comparing the safety and efficacy of the trastuzumab biosimilar MYL-1401O and the FDA-approved trastuzumab (Herceptin), indicating the two were comparable. After 24 weeks, the objective response rates were 69.6% (95% CI: 63.62 to 75.51) for MYL-1401O and 64% (95% CI: 57.81 to 70.26) for trastuzumab. Rates of serious adverse events were comparable at 38.1% among patients receiving MYL-1401O and 36.2% among patients receiving Herceptin.
In a video interview at the annual meeting of the American Society of Clinical Oncology, Dr. Rugo discusses the regulatory future of the biosimilar and prospects for other cancer drug biosimilars. Dr. Rugo is a professor of medicine at the University of California, San Francisco.