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VIDEO: Trastuzumab biosimilar demonstrates safety, efficacy in advanced breast cancer
In this video, Hope S. Rugo, MD, of the University of California, San Francisco, discusses results from the HERiTAge trial, which evaluated the safety and efficacy of a biosimilar trastuzumab antibody compared with the FDA-approved reference product.
Rugo describes the trial design as well as the results seen with MYL-1401O, the trastuzumab biosimilar. The primary endpoint, PFS at 24 weeks, was “identical between the two arms.” Safety, immunogenicity and pharmacokinetics were also similar.
The trastuzumab biosimilar “met the criteria for equivalency based on response rate compared with branded Herceptin in combination with a taxane,” Rugo said. “We should have data on PFS at 48 weeks later this year and the data will be submitted for regulatory approval.”