Phase III IMpassion130 study of Tecentriq plus Abraxane meets co-primary endpoint in triple negative breast cancer.- Genentech/Roche.

Genentech/Roche announced that the Phase III IMpassion130 study met its co-primary endpoint of progression free survival (PFS), demonstrating that the combination of Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]), as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in people with metastatic or unresectable locally advanced triple negative breast cancer (TNBC).

Overall survival (OS) is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis. Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Results will be presented at an upcoming medical meeting and will be submitted to global health authorities, including the FDA and European Medicines Agency (EMA).

Comment: this is the first phase III immunotherapy study to demonstrate a statistically significant progression-free survival improvement in intention-to-treat and PD-L1 positive first-line metastatic triple negative breast cancer.