OSLO, Norway, June 6, 2011 /PRNewswire/ --
- Trial Stopped Based on Data Results from Pre-Planned Interim Analysis; Patients in Placebo Arm Will Be Offered Treatment with Radium-223 Chloride
Algeta ASA today announced that the Phase III ALSYMPCA (radium-223 chloride in SYMptomatic Prostate CAncer) trial evaluating the investigational compound radium-223 chloride, which is exclusively licensed by Bayer, in patients with castration-resistant prostate cancer (CRPC) and bone metastases met its primary endpoint by significantly improving overall survival. Based on a recommendation from the Independent Data Monitoring Committee (IDMC), following a pre-planned interim analysis, the study will be stopped and patients on the placebo arm will be offered treatment with radium-223 chloride. The overall survival result was statistically significant (two-sided p-value =0.0022, HR = 0.699, the median overall survival was 14.0 months for radium-223 chloride and 11.2 months for placebo). The complete results from the study will be presented at an upcoming scientific meeting.
The safety and tolerability of radium-223 chloride were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in the safety profile of radium-223 chloride. Common adverse events from the ALSYMPCA trial included diarrhea, neutropenia and thrombocytopenia
Radium-223 chloride is an investigational agent and is not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other health authorities.
"We are pleased that radium-223 met its primary endpoint of significantly improving overall survival in patients with CRPC and bone metastases, and are hopeful about the potential of radium-223 chloride for this patient population," said Andrew Kay, President and CEO of Algeta.
The filing strategy for radium-223 chloride based on the IDMC's recommendation to stop this study, is being evaluated and patients in the placebo arm will be offered treatment with radium-223 chloride.
Phase III Trial Design
The ALSYMPCA trial is a Phase III, randomized (2:1), double-blind, multi-dose, placebo-controlled international study of radium-223 plus current standard of care compared with placebo plus current standard of care in patients with symptomatic castration-resistant/hormone-refractory prostate cancer that has spread to the bone. The primary endpoint of the study is overall survival. Secondary endpoints include time to occurrence of skeletal related events (SRE), changes and time to progression in prostate-specific antigen (PSA) tests and alkaline phosphatase (ALP) tests, safety and impact on quality of life and health economics. ALSYMPCA was initiated by Algeta ASA (Oslo, Norway) in June 2008. Enrollment in the trial was completed in January 2011 and 922 patients were randomized.