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Home » Bayer’s phase III prostate cancer trial meets primary endpoint

Bayer’s phase III prostate cancer trial meets primary endpoint

September 27, 2011
CenterWatch Staff

Bayer HealthCare Pharmaceuticals has reported that the investigational drug radium-223 chloride showed positive data in 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 (CRPC) and symptomatic bone metastases. All of the main secondary efficacy endpoints analyzed to date were met, including delay in skeletal-related events (SREs).

The data showed that patients who were treated with radium-223 chloride had the following outcomes: median overall survival of 14 months compared to 11.2 months for the placebo group; time to first SREs (13.6 months vs. 8.4 months, 64% improvement); total alkaline phosphatase (ALP) normalization (33% vs. 1% of patients); and a 49% improvement in time to prostate-specific antigen (PSA) progression.

The most common non-hematologic adverse events (occurring in at least 15% of patients) included bone pain (43% vs. 58%), nausea (34% vs. 32%), diarrhea (22% vs. 13%), constipation (18% vs. 18%) and vomiting (17% vs. 13%); and the most common hematologic adverse events included anemia (27% vs. 27%) for patients receiving radium-223 chloride as compared to placebo. With respect to grade 3 to 4 adverse events, the most common events included bone pain (18% vs. 23%) for patients receiving radium-223 chloride as compared to placebo. Following a pre-planned interim analysis, the company agreed with the Independent Data Monitoring Committee's (IDMC) recommendation to stop the study and offer patients on the placebo arm treatment with radium-223 chloride.

Radium-223 chloride was recently granted Fast Track designation by the FDA. The company plans to file a New Drug Application with the FDA for radium-223 chloride in mid-2012.

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