European Commission approves Roche's Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer

F. Hoffmann-La Roche Ltd / European Commission approves Roche's Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Approval based on significant survival benefit of Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy) in people with metastatic non-squamous non-small cell lung cancer (NSCLC) compared with Avastin plus chemotherapy

New treatment option for EGFR mutant or ALK-positive non-small cell lung cancer patients after appropriate targeted therapy

Basel, 08 March 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved and granted marketing authorisation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.

"Today's announcement makes the combination of Tecentriq, Avastin and chemotherapy available to people in Europe with advanced, non-squamous non-small cell lung cancer." said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "This approval includes EGFR mutant or ALK-positive non-small cell lung cancer after failure of a targeted therapy marking a first for this subgroup of patients, in which there is a significant need for alternative treatment options."

This approval is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer, compared with Avastin and chemotherapy (median overall survival [OS]=19.8 versus 14.9 months; hazard ratio [HR]=0.76; 95% CI: 0.63-0.96; p=0.006) in the intention-to-treat (ITT) population.^[1] The safety profile of the Tecentriq combination was consistent with that observed in previous studies.