Women with advanced HER2-positive breast cancer respond to a less expensive experimental drug just as well as the standard drug Herceptin, according to a recent study.
HER2-positive tumors contain genes associated with more rapid tumor growth and worse prognosis. The new drug created to target these tumors is a biosimilar drug, meaning it was designed to mimic the brand-name medicine to produce similar results for patients.
The clinical trial for the biosimilar trastuzumab antibody drug MYL-1401O was conducted at 95 sites in Africa, Asia, Europe and Latin America. The trial included 500 patients. The women received chemotherapy with either Herceptin or MYL-1401O for at least eight cycles, followed by Herceptin alone until their disease progressed.
After six months, the two groups produced similar response rates — 70 percent for MYL-1401O and 64 percent for Herceptin. The rates of serious side effects were also comparable with 36 percent in the Herceptin group and 38 percent in the MYL-1401O.
"[Herceptin] has markedly improved survival of women with HER2-positive breast cancer, but many women around the world can't benefit from [the drug] 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," said Dr. Hope Rugo, MD, a professor of medicine at the University of California and lead author on the study.
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