NEW YORK – The European Commission has approved atezolizumab (Roche's Tecentriq) in combination with chemotherapy for patients with PD-L1-positive, unresectable, locally advanced triple-negative breast cancer, Roche said today.
Simultaneously, the company announced that the Ventana PD-L1 (SP142) Assay had garnered CE marking for this indication. The test may now be used in Europe to identify patients who express PD-L1 in 1 percent or more tumor-infiltrating immune cells, and who are likely to benefit from atezolizumab.
The US Food and Drug Administration approved the same indication for atezolizumab in March alongside the Ventana assay.
European regulators based the drug's approval on the Phase III Impassion 130 study, which showed that treatment with atezolizumab plus nab-paclitaxel reduced the risk of death by 38 percent and improved survival by seven months compared to nab-paclitaxel alone.
In a statement, Roche said the overall survival results in the PD-L1-positive population were not "formally tested" since statistical significance was not met for overall survival in the entire triple-negative breast cancer cohort. Median progression-free survival in the atezolizumab plus chemotherapy arm was 7.5 months compared to 5 months in the comparator arm in PD-L1-positive patients.
Severe adverse events were reported in 23 percent of patients who received Tecentriq and nab-paclitaxel compared to 18 percent in patients who only had chemotherapy.
The Ventana assay is already available in Europe as a companion diagnostic for atezolizumab as a treatment for urothelial carcinoma and for non-small cell lung cancer.