(RTTNews) - Swiss drug major Roche Group (RHHBY) announced Thursday that the European Commission has approved Tecentriq (atezolizumab) in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer or TNBC.
The approval is for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression 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 is based on the results from the Phase III IMpassion130 study. The company noted that progression-free survival results demonstrated a statistically significant benefit for Tecentriq in combination with nab-paclitaxel. It showed that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death by 38% compared with nab-paclitaxel alone in people who were tested positive for PD-L1 expression on tumour-infiltrating immune cells.
At the second interim analysis, Tecentriq and nab-paclitaxel showed a clinically meaningful overall survival improvement of seven months vs placebo and nab-paclitaxel in the PD-L1-positive population.
Currently, seven Phase III studies are ongoing, investigating Tecentriq in TNBC, including early and advanced stages of the disease.