"The AFFIRM data represent an important body of clinical evidence on enzalutamide, a novel oral androgen receptor signaling inhibitor, as a potential new treatment that can prolong the lives of men with advanced prostate cancer. The achievement underlines the importance of integrating clinical observations and basic research to significantly improve patient outcomes and bring therapies to patients faster. It is extremely gratifying to share these results with the medical community," said
In the AFFIRM trial, the data showed that enzalutamide exhibited a statistically significant benefit in overall survival compared to placebo. Men treated with enzalutamide had a median overall survival of 18.4 months (95% confidence interval, 17.3 to not yet reached) compared to 13.6 months (95% confidence interval 11.3 -15.8) for men treated with placebo (hazard ratio 0.63; p < 0.0001), representing a 37 percent reduction in the risk of death.
In the Phase 3 AFFIRM trial three most common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in less than 1% of enzalutamide-treated patients. Serious adverse events were lower in the enzalutamide group than in the placebo group.
About Enzalutamide (formerly MDV3100)
Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors.
(1)Scher, HI, et al. Increased Survival with Enzalutamide in Prostate Cancer After Chemotherapy. New Engl J Med. 2012; 367.
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