Novel Radiopharmaceutical Shows Survival and Quality of Life Benefit to Men with Metastatic PCa
From this year’s European Society for Medical Oncology (ESMO) Congress in Vienna September 28-October 2, 2012
Abstract Title: Updated Survival, Quality of Life and Safety Data of Radium-223 Chloride (RA-223) in patients with castration-resistant prostate cancer with bone metastases from the Phase 3…ALSYMPCA study.
October 02, 2012 -- Rad-223, also known as by its trade name, Alpharadin, is a first-in-class injectable radiopharmaceutical that has undergone late-phase clinical testing; the drug targets radioactive alpha particles to cancer cells that have formed bone metastases in order to eliminate the lesions. Alpharadin is being developed jointly by Bayer Healthcare Pharmaceuticals and Algeta ASA, a Norwegian pharmaceutical company. The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study was a multinational, double-blind, randomized, placebo-controlled Phase III clinical trial evaluating Alpharadin in men with treatment-resistant prostate cancer (also known as castration resistant prostate cancer (CRPC) who have established bone metastases. (The study was successfully finalized this past summer.)
In the study, men meeting the above criteria were either given best standard medical care and placebo or best standard medical care and Alpharadin. Interim results of this study were reported earlier this year, finding that men treated with Alpharadin had 31 percent reduction in risk of death during the trial period compared to men receiving placebo.
At the European Society of Medical Oncology (ESMO) Congress this week in Vienna, Dr. Oliver Sartor, the co-investigator leading the trial in the United States and Dr. Christopher Parker, the European co-PI of the ALSYMCA trial presented updated survival, quality-of-life and safety data of Alpharadin from the ALSYMPCA study on the 921 CRPC patients enrolled in the clinical trial.
Here are some highlights of their presentation at ESMO:
- Men given Alpharadin had a median overall survival benefit of 3.6 months.
- Men given Alpharadin experienced a six month longer timeframe to first skeletal related event, which are defined as complications such as fractures or spinal cord compressions that are caused by metastatic lesions in bone.
- Men given Alpharadin reported significantly better quality of life measures, such as emotional and functional well-being, as compared to men on placebo.
- Overall, the men given Alpharadin tolerated the medication well, with low rates of side effects such as depressed white blood cell or low platelet counts.
The therapeutic effects of Alpharadin are derived from its use of a form of radium that is specifically targeted to the bone where it emits alpha radiation that induces the death of localized tumor cells. Because the effect of the drug is limited to a 10-cell radius, minimal toxicity has been reported.
Alpharadin is the first bone-targeted drug to improve survival in prostate cancer, says study author Dr. Chris Parker. Watch the video below to see him talk about Alpharadin earlier this year.
Dr. Philip Kantoff, the director of The Lank Center for Genitourinary Oncology, and chief of the division of solid tumor oncology at the Dana-Farber Cancer Institute, who was not involved in the study said, “This is proof of principle that if you have a potent agent that targets bone in prostate cancer patients, the natural history of the disease can be altered.”
Click here to see the additional poster presentation information on Alpharadin from ESMO this week.