Among men with metastatic, hormone-refractory prostate cancer, treatment with the investigational drug MDV3100 delayed cancer progression and improved overall survival. These results will be presented at the 2012 Genitourinary Cancers Symposium.

Prostate cancer is a hormonally sensitive disease that can be controlled for long periods with androgen deprivation therapy (ADT). When prostate cancer stops responding to this treatment, it is referred to as hormone-refractory prostate cancer. Advances have been made in the treatment of hormone-refractory cancer, but challenges remain and new drugs continue to be developed.

MDV3100 is an investigational drug with a new approach to hormonal therapy. The drug interferes with the ability of male hormones to bind to their receptors within a cell, and also reduces the ability of the receptors to enter the nucleus and stimulate cell growth.

To evaluate the safety and efficacy of MDV3100 in the treatment hormone-refractory prostate cancer, researchers conducted a Phase III clinical trial known as AFFIRM. The study enrolled 1,199 men with metastatic, hormone-refractory prostate cancer. All of the men had experienced a worsening of their cancer in spite of previous treatment with hormonal therapy and the chemotherapy drug Taxotere® (docetaxel). Study participants were treated with either MDV3100 or a placebo (sugar pill).

  • At the time of an initial analysis part way through the study, researchers found that MDV3100 had significantly improved overall survival: median overall survival was 18.4 months among men treated with MDV3100 and 13.6 months among men treated with placebo. As a result of this benefit, the study was stopped early, and men in the placebo group were offered MDV3100.
  • MDV3100 was also found to delay cancer progression: survival without cancer progression was roughly 8 months among men in the MDV3100 group and 3 months among men in the placebo group.
  • MDV3100 was generally well tolerated. The most common side effects were fatigue, diarrhea, and hot flushes.

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This study suggests that MDV3100 improves outcomes among men with metastatic, hormone-refractory prostate cancer. MDV3100 is also being evaluated for the treatment of earlier stages of prostate cancer.

Reference: Scher HI, Fizazi K, Saad F et al. Effect of MDV3100, an androgen receptor signaling inhibitor (ARSI), on overall survival in patients with prostate cancer postdocetaxel: Results from the phase III AFFIRM study. Presented at the 2012 Genitourinary Cancers Symposium. February 2-4, 2012.San Francisco,CA. Abstract LBA1.

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