Rencarex girentuximab: Phase III ongoing

Wilex said FDA approved the company's plans to skip a planned interim analysis and proceed directly to the final analysis in the double-blind, placebo-controlled Phase III ARISER trial of Rencarex to treat ccRCC. In December, the company said a decline in the trial's rate of recurrence over the past year led an IDMC to conclude that the trial is mature enough to conduct the final analysis of DFS, instead of after 512 events as originally planned (see BioCentury, Dec. 5, 2011). The final analysis and data are expected in 4Q12.

The trial is evaluating once-weekly Rencarex for 24 weeks following complete or partial surgical removal of the affected kidney in 864 patients with no detectable metastases. Wilex completed dosing in 2009. According to Wilex, the IDMC recommended continuation of the trial in 2007 after a planned interim analysis following 100 relapses showed that the trial would "probably deliver a significant result" (see BioCentury, Dec. 17, 2007). ...