(Photos8.com)
A phase 3 clinical trial has shown a new drug to treat prostate cancer is effective with patients who had previously been treated with chemotherapy. The results of the study of MDV3100 — made by the biopharmaceutical company Medivation Inc. in San Francisco and Astellas Pharma Inc. in Tokyo, Japan — will be presented tomorrow at the 2012 Genitourinary Cancers Symposium.
The findings show men taking MDV3100 lived for a median of 18.4 months, compared with 13.6 months for men taking placebo. Patients taking MDV3100 show radiographic progression-free survival of an average of 8.3 months, compared to 2.9 months for the placebo. MDV3100 patients also have a higher soft tissue response rate (28.9% versus 3.8%) and time to prostate-specific antigen or PSA progression (8.3 versus 3.0 months).
In addition, the results show PSA declines of 50 percent or more happened more frequently in the MDV3100 group than in the placebo group (54.0% versus 1.5%), as were PSA declines of 90% or greater (24.8% versus 0.9%). All of the comparative findings were statistically significant.
The trial also indicates that MDV3100 was well tolerated. Common side effects included fatigue, diarrhea, and hot flush. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the MDV3100 group than in the placebo group.
The trial was conducted at 166 sites under the direction of Howard Scher of Memorial Sloan-Kettering Cancer Center (MSKCC) in New York. Earlier research on the drug through preclinical tests on animals was conducted in the lab of Charles Sawyers, a Howard Hughes Medical Institute investigator, first at UCLA and later at MSKCC.
Medivation licensed the compound for commercial development in 2005, and set up the clinical trials, initially at MSKCC, which were later expanded to other sites. The company plans to file a new drug application with the Food and Drug Administration later this year.
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