Roche gets both approval and marketing authorisation for Tecentriq combination in Europe. Credit: F. Hoffmann-La Roche Ltd.

The European Commission (EC) has approved the use of Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab), paclitaxel and carboplatin as the first-line therapy for metastatic non-squamous non-small cell lung cancer (NSCLC).

The regulatory authority also granted marketing authorisation for the combination. The indication for the combination covers EGFR mutant or ALK-positive NSCLC patients who did not respond to prior targeted treatments.

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Tecentriq is a monoclonal antibody that prevents PD-L1 interactions with PD-1 and B7.1 receptors, while Avastin is a biologic antibody targeting vascular endothelial growth factor (VEGF) protein.

Tecentriq is expected to facilitate T-cell activation, and Avastin is designed to hinder the tumour blood supply.

“This approval follows a failure of a targeted therapy marking a first for this subgroup of patients, in which there is a significant need for alternative treatment options.”

The restricted blood supply to the tumour facilitated by Avastin is thought to boost the ability of Tecentriq to restore anti-cancer immunity.

Combining these drugs may thus increase the overall ability of the immune system to fight cancer.

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Roche chief medical officer and Global Product Development head Sandra Horning said: “Today’s announcement makes the combination of Tecentriq, Avastin and chemotherapy available to people in Europe with advanced, non-squamous NSCLC.

“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.”

The EC decision is based on data from the Phase III IMpower150 trial conducted to assess the safety and efficacy of the Tecentriq, Avastin and chemotherapy combination.

A total of 1,202 stage IV or recurrent metastatic non-squamous NSCLC patients took part in the trial.

Results demonstrated 19.8 months of median overall survival in the combination regimen arm, compared to 14.9 months in case of patients who received Avastin and chemotherapy.

Additionally, the safety profile of the Tecentriq combination was found to be consistent with that observed in previous studies.

 

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