Roche’s Tecentriq combo scoops up European approval in first-line metastatic lung cancer
pharmafile | March 8, 2019 | News story | Medical Communications, Sales and Marketing | Cancer, Europe, European Commission, NSCLC, Roche, lung cancer, pharma
Roche has announced the approval of the European Commission for its PD-L1 inhibitor Tecentriq (atezolizumab) when used in combination with Avastin (bevacizumab), paclitaxel and carboplatin as a first-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC).
Further, the EC specified that this combination should only be used in patients with EGFR mutant or ALK-positive NSCLC after appropriate targeted therapies have failed.
The decision was supported by the submission of Phase 3 data drawn from 1,202 participants which demonstrated that Roche’s combo extended median overall survival by 19.8 months compared to 14.9 months with Avastin and chemotherapy alone in the intent-to-treat population. The combo also improved progression-free survival (PFS) by 41% compared to Avastin and chemotherapy, while overall response rate (ORR) stood at 56.4% of people compared to 40.2%.
“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,” commented Dr Sandra Horning, 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.”
Matt Fellows
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