ARTICLE | Clinical News

Cobimetinib: Additional Phase III data

November 3, 2014 8:00 AM UTC

Additional data from the double-blind, placebo-controlled, international Phase III coBRIM trial in 495 previously untreated patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma showed that once-daily 60 mg oral cobimetinib on days 1-21 of a 28-day cycle plus twice-daily 960 mg oral Zelboraf vemurafenib led to a median PFS, the primary endpoint, as assessed by the investigators of 9.9 months vs. 6.2 months for Zelboraf alone (p<0.0001). On secondary endpoints, cobimetinib plus Zelboraf significantly improved median PFS as assessed by an independent review committee (11.3 vs. 6 months, p=0.0003) and improved ORR (68% vs. 45%, p<0.0001) vs. Zelboraf alone. OS data are not yet mature but Exelixis said that at the interim analysis, the p-value did not cross the pre-specified boundary for significance (p=0.046). Data were presented at the European Society for Medical Oncology meeting in Madrid and published in The New England Journal of Medicine. Exelixis previously reported that the combination met the primary endpoint of improving PFS vs. Zelboraf alone (see BioCentury, July 21). ...