Genentech: Follow-up Data From Cobimetinib Study Shows Progression-free Survival

(RTTNews) - Genentech, a member of Swiss pharmaceutical giant Roche Group (RHHBY.PK, ROG.SW, RO.SW), announced follow-up data from two studies of the investigational MEK inhibitor cobimetinib in combination with Genentech's BRAF inhibitor Zelboraf, or vemurafenib.

Updated data from the pivotal coBRIM Phase III study showed the combination helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of one year, or 12.3 months, without their disease worsening or death, compared to 7.2 months with Zelboraf alone. The updated results from coBRIM also demonstrated higher response rates with cobimetinib and Zelboraf, compared to Zelboraf alone.

Follow-up data from the Phase Ib BRIM7 study showed cobimetinib plus Zelboraf helped people who had not been previously treated with a BRAF inhibitor live a median of more than two years, or 28.5 months. In addition, extended follow-up showed 61 percent of patients who had not been previously treated with a BRAF inhibitor were alive after two years.

Genentech will present the coBRIM and BRIM7 data during the 51st Annual Meeting of the American Society of Clinical Oncology or ASCO meeting in Chicago held from May 29 to June 2.

The cobimetinib new drug application for BRAF V600 mutation-positive advanced melanoma was granted priority review by the U.S. Food and Drug Administration, and a decision is expected by August 11, 2015. The European Medicines Agency is expected to make a decision on Roche's marketing authorization application for cobimetinib before the end of 2015.