Phase III trial of Mekinist + Taflinar for Metastatic Melanoma halted early - GSK

GlaxoSmithKline has announced that the Independent Data Monitoring Committee (IDMC) recommended COMBI-v (MEK116513), a Phase III study of Mekinist (trametinib) in combination with Tafinlar (dabrafenib) compared to vemurafenib in patients with BRAF V600E or V600K mutation-positive unresectable or Metastatic cutaneous Melanoma be stopped early. This recommendation is based on an interim analysis which demonstrated an overall survival benefit for the trametinib and dabrafenib combination compared to vemurafenib that crossed the pre-specified efficacy stopping boundary.

The safety profile of the trametinib and dabrafenib arm was consistent with the safety profile of the combination observed to date. COMBI-v enrolled 704 patients from investigative sites in the U.S., Europe, Canada, Russia, Ukraine, Israel, Argentina, Brazil, Korea, New Zealand, Taiwan, and Australia. The combination was approved by the FDA in January 2014. GSK now plans to resubmit an MAA to the EU with new data, following its withdrawal in March.