Bayer announces updated data from radium-223 dichloride Phase III trial on CRPC

Bayer HealthCare today announced updated data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial for its investigational drug radium-223 dichloride in men with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. Radium-223 dichloride significantly increased overall survival (HR=0.695, p=0.00007). The median overall survival (OS) benefit in patients given radium-223 dichloride increased from 2.8 months at the time of the pre-planned interim analysis in June 2011 to 3.6 months in this updated analysis [14.9 months in the radium-223 dichloride group plus best standard of care (BSC) vs. 11.3 months with placebo plus BSC]. These and additional data will be presented as a late-breaking abstract in an oral abstract session on June 5^th at the 48^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (LBA No. 4512).

"Bone metastases are one of the main causes of morbidity and death in patients with castration-resistant prostate cancer, yet until now there has been little progress made towards developing therapies that treat the cancer when it has spread to the bone," said Dr. Chris Parker of The Royal Marsden NHS Foundation Trust, London, and The Institute of Cancer Research, London, and principal investigator of ALSYMPCA.

In addition to improving OS, radium-223 dichloride led to a statistically significant delay in the time to first skeletal-related event (SRE) in men with CRPC with bone metastases.

The overall safety and tolerability profile for radium-223 dichloride was consistent with previous study results. The most common hematologic adverse events included anemia (31% vs. 31%), neutropenia (5% vs. 1%) and thrombocytopenia (12% vs. 6%) for patients receiving radium-223 dichloride compared to placebo. With respect to Grade 3 and 4 adverse events, the most common events included anemia (13% vs. 13%), neutropenia (2% vs. 1%) and thrombocytopenia (6% vs. 2%). The most common non-hematologic adverse events included bone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs. 15%) and vomiting (19% vs. 14%) for patients receiving radium-223 dichloride as compared to placebo. With respect to Grade 3 to 4 adverse events, the most common events included bone pain (21% vs. 26%).

"These updated survival data with radium-223 dichloride are encouraging and may provide a new treatment option for men who are fighting prostate cancer at its most aggressive stage," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "Radium-223 dichloride is a chief example of Bayer's commitment to researching innovative therapies for diseases where few options currently exist for patients."