Bayer HealthCare Pharmaceuticals Inc. today announced that the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial evaluating Bayer's investigational compound, radium-223 chloride, which is exclusively licensed from Algeta ASA, 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 chloride 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 Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee.
The company is evaluating the filing strategy for radium-223 chloride based on the IDMC's recommendation to stop this study and will offer patients in the placebo arm treatment with radium-223 chloride.
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