Phase III study results for Tecentriq + Cotellic + Zelboraf for previously untreated BRAF V600 mutation-positive advanced melanoma.-Genentech/Roche

Genentech, a member of the Roche Group announced the Phase III IMspire150 study, in people with previously untreated BRAF V600 mutation-positive advanced melanoma, met its primary endpoint of progression-free survival (PFS). The study showed adding Tecentriq (atezolizumab) to Cotellic (cobimetinib) and Zelboraf (vemurafenib) helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf. A significant and clinically meaningful improvement in PFS was demonstrated in the study.

The safety profile observed in IMspire150 was consistent with the known safety profiles of the individual medicines. Results from the study will be presented at an upcoming medical meeting and discussed with health authorities, including the FDA and European Medicines Agency. Genentech has an extensive clinical trial development program for Tecentriq, with more than 50 ongoing studies, including multiple Phase III studies across lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, blood, liver and head and neck cancers. Studies are evaluating Tecentriq alone and in combination with other medicines.

About the IMspire150 study : IMspire150 is a Phase III, multi-center, double-blind, placebo-controlled randomized study in people with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. The study compared the efficacy and safety of Tecentriq plus Cotellic and Zelboraf to the combination of placebo plus Cotellic and Zelboraf. The primary endpoint of the study was investigator-assessed PFS. Key secondary endpoints include PFS by an independent review committee, overall survival, objective response rate, duration of response and other safety and pharmacokinetic measures.