The European Commission has approved the combination of Tecentriq (atezolizumab) plus chemotherapy (Abraxane) for the treatment of patients with locally unresectable or metastatic advanced breast cancer with tumors positive for PD-L1 expression (≥1%) who have not received treatment previous with chemotherapy for metastatic disease.
“We are delighted to continue advancing in this objective and to be able to announce now that the first immunotherapy-based treatment for patients with triple negative metastatic breast cancer with positive expression of PD-L1 is available in Europe,” said Sandra Horning, Chief Medical Officer and responsible for Global Product Development of Roche.
This approval has been based on data from the phase III study IMpassion130. Progression-free survival (SLP) results show a statistically significant benefit associated with the combination of Tecentriq and nab-paclitaxel, which reduced the risk of disease progression or death (PFS) by 38% compared to nab-paclitaxel alone (mean SLP = 7.4 vs 5 months; RH = 0.62, 95% CI 0.49-0.78, p <0.0001) in patients positive for PD-L1 expression evaluated in infiltrating lymphocytes of the tumor.
In the second intermediate analysis, the combination of Tecentriq and nab-paclitaxel showed a clinically significant overall survival improvement (OS) of seven months compared to placebo and nab-paclitaxel in positive PD-L1 population (mean SG = 25.0 vs. 18.0 months; RH = 0.71; 95% CI: 0.54 to 0.93). The results of OS in the PD-L1 positive population were not formally tested due to the hierarchical design of the study and because the statistical significance for OS in the population was not met by intention to treat.
Currently, there are seven ongoing Phase III studies investigating Tecentriq in triple negative breast cancer, including early and advanced stages of the disease.