TECENTRIQ, COTELLIC Did Not Meet Primary Endpoint

Genentech announced the Phase III IMblaze370 study evaluating the combination of TECENTRIQ (atezolizumab) and COTELLIC (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens.

More than 95 percent of patients in IMblaze370 have microsatellite stable (MSS) tumors and based on the available data, checkpoint inhibitors as monotherapy have not demonstrated clinically meaningful efficacy in MSS mCRC. The results from IMblaze370 were consistent with this prior monotherapy experience, showing that treatment with TECENTRIQ alone did not provide a meaningful clinical benefit compared to regorafenib in this patient population.

Safety for the combination of TECENTRIQ and COTELLIC appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The results from IMblaze370 will be further examined and presented at an upcoming medical meeting.

"While these results are not what we hoped for, we remain committed to applying our deep experience to develop medicines that will improve outcomes for people living with gastrointestinal cancers," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "In particular, we have a number of studies evaluating medicines in colorectal cancer that could play an important role in the treatment of people with this disease in the future."

Genentech has an extensive clinical trial development program for TECENTRIQ, with more than 50 studies ongoing, including multiple Phase III studies across lung, kidney, skin, breast, colorectal, prostate, ovarian, bladder, blood, liver and head and neck cancers. This includes studies evaluating TECENTRIQ both alone and in combination with other medicines.

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