In a poster presentation at the recent European Society of Medical Oncologists (ESMO) there was a very interesting poster presented updating a phase 3 clinical trial (CA184-043) which evaluated the overall survival (OS) with radiotherapy (RT) followed by either the immunologic drug Ipilimumab (Ipi) or with a placebo. This trial did not meet its endpoint and was considered to have failed (Kwon ED, et al. Lancet Oncol 2014 in press), but it still remains of significant interest. The update included an additional year of data.
In the trial 799 men were randomized to receive a single dose of radio therapy to their bone metastases followed by either Ipi (N = 399) or placebo (N = 400). An updated overall survival analysis was performed.
Updated OS analysis with survival rates up to 3 years was consistent with the primary analysis. Also consistent with previous reports, pre-specified subgroup analyses suggest greater activity in men with lower disease burden