Roche announced that the European Commission has approved Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [nab-paclitaxel]) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors have PD-L1 expression (≥1%) and who have not received prior chemotherapy for metastatic disease. Roche’s VENTANA PD-L1 (SP142) Assay is now CE marked and commercially available in the European Union as an aid for identifying patients with TNBC eligible for treatment with the Tecentriq combination.
 
The approval of the Tecentriq plus nab-paclitaxel combination is based on the results from the Phase III IMpassion130 study. Progression-free survival (PFS) results demonstrated a statistically significant benefit for Tecentriq in combination with nab-paclitaxel and showed that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 38% compared with nab-paclitaxel alone. 

“For the past 30 years, we have been dedicated to transforming the lives of people with breast cancer. Now, we are pleased to build on this foundation with the news that the first immunotherapy treatment for triple-negative breast cancer is available to people in Europe with PD-L1-positive, metastatic triple-negative breast cancer,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The European approval of this Tecentriq combination represents a significant step forward in the treatment of this aggressive breast cancer, where the unmet medical need is great.”