The FINANCIAL -- Bayer HealthCare Pharmaceuticals today
announced positive data on its investigational drug Alpharadin from the
Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.
The study met its primary endpoint by significantly improving overall survival by 44% in patients with castration-resistant prostate cancer and symptomatic bone metastases. All of the main secondary endpoints were met, including delay in time to first skeletal-related events. These data will be presented during the Presidential Session at the 2011 European Multidisciplinary Cancer Congress in Stockholm, Sweden. The 2011 European Multidisciplinary Cancer Congress is the 16th congress of the European CanCer Organisation, the 36th congress of the European Society for Medical Oncology and the 30th congress of European Society for Therapeutic Radiology and Oncology .
The data showed that patients who were treated with Alpharadin had the following outcome:
A median overall survival of 14 months compared to 11.2 months for the placebo group,
Median time to first SREs of 13.6 vs. 8.4 months ,
Total alkaline phosphatase normalization in 33% of patients taking Alpharadin vs. 1% of patients on placebo A 49% improvement in time to prostate-specific antigen progression.
The overall safety and tolerability profile for Alpharadin was consistent with previous study results. The most common non-hematologic adverse events included bone pain , nausea , diarrhea , constipation and vomiting ; and the most common hematologic adverse events included anemia. In respect to Grade 3 to 4 adverse events, the most common events included bone pain.The trial was halted earlier this year following a pre-planned interim analysis to offer patients on the placebo arm treatment with Alpharadin.
“These data are significant because they demonstrate that Alpharadin can prolong life in patients with castration-resistant prostate cancer and bone metastases,” said Dr. Chris Parker of the Royal Marsden Hospital, London, and principal investigator of ALSYMPCA. “These results and previous study findings suggest that Alpharadin, a novel alpha-pharmaceutical, may provide a new standard of care for the treatment of castration-resistant prostate cancer patients with bone metastases.”
Alpharadin was recently granted Fast Track designation by the U.S. Food & Drug Administration (FDA). The Fast Track process is designed to facilitate the development, and expedite the review, of drugs to treat serious diseases and fill an unmet medical need. Fast Track designation must be requested by the drug company and can be initiated at any time during the drug development process. The company plans to file Alpharadin with regulatory authorities in the U.S. and Europe based on these data in mid-2012.
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