Roche’s checkpoint inhibitor Tecentriq has gained a new approval from the European Commission, for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC), its fourth indication in this cancer type.

Specifically, Tecentriq (atezolizumab) has been approved for adults with metastatic NSCLC whose tumours have high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.

The approval is based on data from Roche’s Phase III IMpower110 study which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months in patients with high PD-L1 expression.

An updated exploratory OS analysis in the PD-L1 population, presented at the World Conference on Lung Cancer 2020, showed a continued benefit at a median follow-up of 31.3 months.

The median OS in the Tecentriq arm was the same as that observed in the previous analysis – 20.2 months. In the chemotherapy arm, the median OS was found to be 14.7 months.

The safety for Tecentriq in this study was consistent with its known safety profile, with no new safety signal identified. In the Tecentriq-treated population, grade 3-4 treatment-related adverse events were reported in 12.9% of people compared with 44.1% of people receiving chemotherapy.

In a statement, Roche said that Tecentriq is now the first and only single-agent cancer immunotherapy with three dosing options – it can be administered every two, three or four weeks.

“We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” said Levi Garraway, chief medical officer and head of global product development at Roche.

“Tecentriq monotherapy has been shown to improve overall survival in people with high PD-L1 expression, when compared to chemotherapy, and therefore represents a new treatment option for people living with this difficult-to-treat disease,” he added.

Tecentriq is approved across four indications in NSCLC in Europe, including as a single agent or in combination with other targeted therapies and/or chemotherapies.

It was also the first immunotherapy approved for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with chemotherapy (carboplatin and etoposide).