CHMP recommends Cotellic (cobimetinib) + Zelboraf (vemurafenib) to treat BRAF V600 mutation-positive unresectable or metastatic melanoma- Roche

Roche has announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Cotellic (cobimetinib), when used in combination with Zelboraf (vemurafenib), for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. Approximately 50% of melanoma skin cancers are BRAF-positive, and more than 55,000 people worldwide die every year from melanoma.

The CHMP’s recommendation is based primarily on results of the pivotal Phase III coBRIM study. These data showed that people who received the combination of cobimetinib and vemurafenib lived over a year without their disease worsening (median progression-free survival of 12.3 months, compared to 7.2 months with vemurafenib alone; hazard ratio 0.58, 95 percent confidence interval 0.46–0.72). The objective response rate was also higher for the combination arm compared to vemurafenib alone (70 vs. 50%; p<0.0001). The most common adverse events in the combination arm of the pivotal study were diarrhoea, rash, nausea, fever, sun sensitivity, liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and vomiting.

Comment: The cobimetinib/vemurafenib combination will be in direct competition with Mekinist/Tafinlar combination from Novartis of the MEK inhibitor trametininb and the BRAF inhibitor dabrafenib, respectively. This combination was already approved in the US and recently in the EU.