The EC has approved Tecentriq in combination with Avastin, paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC).
Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies in patients with EGFR mutant or ALK-positive NSCLC.
The approval was based on data from the phase III IMpower150 study, which demonstrated that Tecentriq in combination with Avastin and chemotherapy allowed people to live longer compared against Avastin and chemotherapy.
IMpower150 is a multicentre, open-label, randomized and controlled phase III study designed to assess the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease.
The company recruited 1,202 patients in the trial, and randomized to secure Tecentriq plus carboplatin and paclitaxel in the arm A, Tecentriq and Avastin plus carboplatin and paclitaxel in the arm B and Avastin plus carboplatin and paclitaxel Arm C or control arm
Tecentriq is a monoclonal antibody designed to bind with a protein known as PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, enabling to restrict its interactions with both PD-1 and B7.1 receptors.
Tecentriq can activate T cells by blocking PD-L1. Tecentriq can be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a range of cancers.
At present, the firm is assessing Tecentriq alone or in combination with other medicines in nine phase III lung cancer studies.
Roche chief medical officer and global product development head Dr Sandra Horning said: “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.
“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.”