A new drug, MDV3100, is improving the survival rate in men with advanced prostate cancer, according results presented at the American Society of Clinical Oncology Genitourinary meeting.
The drug is designed to block a type of cellular receptor that drives progression of prostate cancer.
Howard Scher, Chief of the Genitourinary Service at Memorial Sloan-Kettering Cancer Center in New York (MSKCC) says the data from the study show that men treated with MDV3100 in the Phase III trial had a median survival of 18.4 months, compared with 13.6 months for men treated with placebo.
“This translates into a 37% reduction in the risk of death in patients who are treated with MDV3100,” said Scher.
Scher is co-principal investigator of the AFFIRM clinical trial, a randomised, double-blind, placebo-controlled, multinational trial evaluating MDV3100 versus placebo in nearly 1,200 men with advanced prostate cancer who were previously treated with hormonal therapy and docetaxel-based chemotherapy.
Docetaxel therapy interferes with cell division, and was the first drug shown to prolong survival in patients with advanced prostate cancer.
The men participating in the AFFIRM study were enrolled because their cancer advanced despite receiving hormone therapy and chemotherapy.
Last November, the AFFIRM study was stopped early when an interim analysis indicated that MDV3100 prolonged survival.
Medivation plans to submit a new drug application to the FDA requesting approval for MDV3100 later this year.
“The reduction in mortality in this Phase III study was higher than we had anticipated,” said Scher.
“This drug is prolonging survival in patients with a particularly hard-to-treat cancer.
“As a clinical scientist who’s own research is focused on prostate cancer drug development, having the opportunity to follow the science and then lead the development of the drug from the treatment of the first patient through the end of Phase III has been one of the most satisfying and exhilarating experiences in my career.”