This article has been updated to include companion diagnostic approval information.
NEW YORK – Genentech said on Monday that the US Food and Drug Administration has approved atezolizumab (Tecentriq) as a first-line treatment for metastatic non-small cell lung cancer that expresses PD-L1 in 50 percent or more of tumor cells and has no genetic aberrations in EGFR or ALK.
The FDA also approved the VENTANA PD-L1 SP142 Assay by Ventana Medical Systems as a companion diagnostic device for selecting NSCLC patients for treatment with atezolizumab.Â
The approval was based on data from the interim analysis of the Phase III IMpower110 study, where high PD-L1-expressing patients treated with atezolizumab had an overall survival advantage of 7.1 months compared to patients treated with chemotherapy. During the trial, 12.9 percent of patients in the atezolizumab arm and 44.1 percent of patients in the chemotherapy arm reported grade 3 to 4 treatment-related adverse events.
Atezolizumab is a monoclonal antibody designed to bind and block the interactions of the protein PD-L1, found on tumor cells and tumor-infiltrating immune cells, and reactivate T cells. In IMpower110, researchers excluded individuals with EGFR and ALK mutations, who are eligible for other molecularly targeted treatments.
Last December, the FDA approved atezolizumab in combination with chemotherapy (paclitaxel protein-bound and carboplatin) as a first-line option for adult patients with metastatic non-squamous NSCLC without EGFR or ALK genomic tumor aberrations, regardless of PD-L1 status.