Bayer presented full data at the European Multidisciplinary Cancer Congress (EMCC) on Saturday from the company's late-stage ALSYMPCA trial investigating Alpharadin (radium-223 chloride) in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. The drugmaker halted the study in June ahead of schedule after an interim analysis found it had met its main goal, showing that Alpharadin significantly improved overall survival compared to placebo.
In the trial, 922 men with symptomatic CRPC that had spread to the bone were randomised to receive treatment with Alpharadin plus best standard of care, or placebo plus best standard of care. Results of the study showed that patients who received Bayer's drug had a 30-percent lower risk of dying than those who received placebo, with median overall survival for the two arms of 14 months and 11.2 months, respectively. The company noted that the study also met all of its main secondary endpoints, including delay in time to first skeletal-related events.
"These data are significant because they demonstrate that Alpharadin can prolong life in patients with castration-resistant prostate cancer and bone metastases," commented the study's principal investigator Chris Parker. He added that the agent has "a completely different safety profile" to chemotherapy. In the trial, Grade 3 to 4 adverse events occurred in 18 percent of patients who took Alpharadin, compared to 23 percent of those who took placebo.
Bayer spokeswoman Anna Koch said the drugmaker plans to apply for regulatory approval in Europe and the US by the middle of next year based on these data. In August, the FDA granted fast track status to Alpharadin for the treatment of CRPC in patients with bone metastases. The therapy, if approved, may generate peak sales of 640 million euros ($882 million) by 2018, according to Berenberg Bank analyst Alistair Campbell.
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