Girentuximab: Phase III data

Wilex said an independent DMC has recommended terminating the double-blind, international Phase III ARISER trial in 864 clear cell RCC patients after IV Rencarex missed the trial's primary endpoint of improving median DFS vs. placebo. Specifically, Rencarex showed no improvement on the endpoint compared to placebo with a median DFS of about 72 months. Rencarex was well tolerated. As a result, Wilex said it will now focus resources on developing its clear cell RCC diagnostic, Redectane, and on other clinical programs. ARISER was evaluating once-weekly Rencarex for 24 weeks following complete or partial surgical removal of the affected kidney in patients with no detectable metastases.

According to the company, the independent DMC 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). In February, Wilex said FDA approved the company's plans to skip a planned interim analysis and proceed directly to the final analysis (see BioCentury, March 5). Last November, the company said a decline in the trial's rate of recurrence over the past year led the independent DMC 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). ...