OREANDA-NEWS. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved CotellicTM (cobimetinib) for use in combination with Zelboraf® (vemurafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The EU approval is based on data that showed Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without their disease worsening1.

“There has been significant progress in the treatment of melanoma, with more medicines being approved in the past five years than in the previous 30,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "Together, Cotellic plus Zelboraf more strongly suppressed cancer growth than Zelboraf alone. This underscores the critical role of combination medicines in helping melanoma patients live longer without their disease worsening."

Today’s EU approval is based primarily on results of the Phase III coBRIM study, which showed that people with previously untreated BRAF V600 mutation-positive advanced melanoma who were being treated with the MEK inhibitor Cotellic in combination with Zelboraf lived a median of one year (12.3 months) without their disease worsening or death (progression-free survival; PFS) compared to 7.2 months with Zelboraf alone (hazard ratio [HR]=0.58; 95 percent confidence interval [CI] 0.46-0.72).1

The objective response rate (ORR) with the combination was 70 percent (16 percent complete response [CR], 54 percent partial response [PR]) compared to 50 percent (11 percent CR, 40 percent PR) in the Zelboraf arm.1 The safety profile of Cotellic plus Zelboraf was consistent with safety data previously reported. The most common adverse events in the combination arm were diarrhea, rash, nausea, fever, sun sensitivity, liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and vomiting.

Additional data were presented on November 21, 2015 at the Society for Melanoma Research congress demonstrating that the combination of Cotellic plus Zelboraf met its secondary endpoint of improving overall survival compared to Zelboraf alone. These data will be submitted to the European Medicines Agency for consideration and inclusion in the label. Cotellic in combination with Zelboraf is now approved in the EU and Switzerland for the treatment of people with BRAF V600 mutation-positive advanced melanoma. In the US, the combination is approved for the treatment of people with BRAF V600E or V600K mutation-positive advanced melanoma. Further country approvals are anticipated in 2016.