Positive Survival Data from Interim Analysis of Phase III Trial of Prostate Cancer Drug
3 November 2011 - A new type of hormonal treatment has been shown to extend life for men with advanced prostate cancer, according to an interim analysis of a Phase III trial jointly led by Professor Johann de Bono from the ICR and The Royal Marsden Hospital.
The once-daily pill, known as MDV3100, is the first in a new class of medicines called androgen receptor signaling inhibitors (ARSI). Prostate cancer relies on testosterone to grow, so this drug has been designed to bind to the receptors on prostate cancer cells that normally interact with testosterone, and block this interaction. MDV3100’s novel mechanism of action involves inhibiting androgen receptor signaling at three distinct points in the signaling pathway.
The drug has been tested in 1,199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy.
Patients treated with MDV3100 lived an average 4.8 months longer than those given a placebo. The estimated median survival for men treated with MDV3100 was 18.4 months compared with 13.6 months for men treated with placebo.
As a result, the Independent Data Monitoring Committee recommended that the trial be stopped early and men who received the placebo be offered MDV3100.