Algeta ASA has announced that updated data from the pivotal phase III ALSYMPCA trial for its investigational drug Alpharadin (radium-223 dichloride) confirm the improvement in overall survival of Alpharadin in men with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases, compared to the interim analysis from June 2011.
The updated data showed that Alpharadin improved overall survival by 44% (p=0.00007, HR=0.695), resulting in a 30.5% reduction in the risk of death compared to placebo.
The median overall survival benefit with Alpharadin was 2.8 months at the time of the interim analysis in June 2011 and 3.6 months in this updated analysis (14.9 months in patients given Alpharadin vs. 11.3 months with placebo).
These data will be presented as a late-breaking abstract in an oral abstract session on June 5, 2012 at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL (USA) (LBA No. 4512).
“Bone metastases are one of the main causes of disability and death in patients with castration-resistant prostate cancer, yet until now there has been little progress made towards developing therapies that target 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.
“Alpharadin is the first therapy specifically addressing cancer that has spread to the bone that has shown, in a phase III trial, to significantly improve overall survival.”
In addition to improving overall survival, radium-223 dichloride led to a statistically significant delay in the time to first skeletal-related event (SRE).
The overall safety and tolerability profile for Alpharadin 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 Alpharadin 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 Alpharadin as compared to placebo. With respect of Grade 3 to 4 adverse events, the most common events included bone pain (21% vs. 26%).
Andrew Kay, President & CEO of Algeta, commented: “The results from the extensive clinical program evaluating Alpharadin continue to give us confidence in its potential, pending marketing approvals, to become a new treatment option for cancer patients with bone metastases. This is a significant achievement for Algeta. In turn, this provides a strong foundation on which we are building a global oncology company with a high quality commercial organization in the US allied to our research and development headquarters in Norway.”
Alpharadin has been granted Fast Track designation by the US 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.
Bayer plans to file Alpharadin seeking marketing approval for CRPC with regulatory authorities in the US and Europe based on the ALSYMPCA data in the second half of 2012.
In terms of further development activities, Bayer intends to conduct studies in earlier settings of prostate cancer, including combination studies with other agents, as well as undertaking exploratory studies in other tumors such as breast cancer and osteosarcoma.