TRIP

Prostate Cancer Bone Mets Target of New Agent (with audio)

MedPageToday, 2012

by 30% to 14.0 months versus 11.2 months with placebo in the trial, as reported late last year at the European Multidisciplinary Cancer Congress (formerly ECCO-ESMO).
"We believe this novel alpha-pharmaceutical -- the very first one to be tested in all of medicine -- may provide a new standard of care for the treatment of patients with bone metastases in advanced prostate cancer," Sartor told reporters.
Radium-223 is a first-in-class agent that acts like calcium and localizes to areas of bone stroma damaged by tumor, where the short-range alpha particle radiation reaches only adjacent cells without hurting normal tissue.
Oncology and an investigator in the trial, echoed the excitement voiced over the primary survival results.
"In a simple, additive way, we would expect the survivals to be fairly dramatically pushed forward."
Beyond additive benefits from sequential therapy, combinations might be synergistic, Sartor suggested.
He pointed to the distinct mechanisms of radium-223 and another novel agent, the anti-androgen , reported at the briefing to boost hormone-refractory prostate cancer survival by an equally impressive five months.
The FDA agreed to fast-track review of radium-223, and that submission is under way based on the ALSYMPCA results without a need for additional data anticipated, according to Sartor.
The ALSYMPCA trial included 922 men with confirmed symptomatic castration-resistant prostate cancer and at least two bony metastases, but no visceral metastases.
Most participants had progressed after docetaxel (Taxotere), but some had been deemed unfit for docetaxel, which Sartor noted is a group often excluded from trials.
Both the radium-223 and the placebo group got best standard of care, which could include second hormonal therapies but not chemotherapy, experimental therapy, or some kinds of radiation.