MDVN $36 with improved life expectancy! Medivation and Astellas (ALPMY.PK) announced positive survival data from interim analysis of Phase 3 AFFIRM trial of MDV3100 in men with advanced prostate cancer (MDVN) 16.53 : MDVN and Astellas Pharma (ALPMY.PK) announced that the Independent Data Monitoring Committee has informed the companies of positive results from a planned interim analysis of the Phase 3 AFFIRM trial of MDV3100 in men with advanced prostate cancer previously treated with chemotherapy. MDV3100, the first androgen receptor signaling inhibitor, successfully met the study's pre-specified interim efficacy stopping criteria, demonstrating a clinically meaningful and statistically significant improvement in overall survival compared to placebo. As a result, the IDMC recommended that AFFIRM be stopped early and men who received placebo be offered MDV3100. As reported by the IDMC, MDV3100 produced a 4.8-month advantage in median overall survival compared to placebo. The estimated median survival for men treated with MDV3100 was 18.4 months compared with 13.6 months for men treated with placebo. MDV3100 provided a 37 percent reduction in risk of death compared to placebo. The IDMC further determined, considering the observed safety profile, that MDV3100 demonstrated a favorable risk-to-benefit ratio sufficient to stop the study. A full analysis of the results from AFFIRM, including safety data, will be submitted for presentation at an upcoming scientific congress.
