Final results of coBRIM study with Cotellic (cobimetinib) + Zelboraf (vemurafenib) show survival benefits in metastatic melanoma- Genentech/Roche

Genentech/Roche have announced data from the pivotal coBRIM study, which showed that Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) helped people with BRAF V600E and V600K mutation-positive unresectable or metastatic melanoma live significantly longer (overall survival; OS) than with Zelboraf alone. Cotellic plus Zelboraf reduced the risk of death by 30 percent compared to Zelboraf alone and helped people live a median of nearly two years (median OS 22.3 months vs. 17.4 months). Ongoing study monitoring did not identify any new safety signals.

This final analysis of the OS data from coBRIM showed that with the combination of Cotellic and Zelboraf, 74.5 percent of people with BRAF V600 mutation-positive advanced melanoma in the study were alive at one year and 48.3 percent were alive at two years. The results were presented during the 12th International Congress of the Society for Melanoma Research.

The announcement follows the FDA approval of Cotellic for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf. A decision from the European Commission is expected before the end of 2015. The final OS results are being submitted to both of these health authorities for consideration.

Comment: The Cotellic /Zelboraf combination will be in direct competition with Mekinist/Tafinlar combination from Novartis (formerly GSK) of the MEK inhibitor trametininb and the BRAF inhibitor dabrafenib, respectively. This combination was already approved in the US and recently in the EU. Combining the two mechanisms of action (MEK and BRAF inhibition) is expected to change the standard of care in this indication, by providing more complete blockade of the MAP kinase pathway to delay the emergence of resistance.