Genentech/Roche provides update on phase III study Of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer.

Genentech, a member of the Roche Group announced that the Phase III IMpassion131 study, evaluating Tecentriq (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival (PFS) for the initial (first-line) treatment of people with metastatic triple-negative breast cancer (TNBC), in the PD-L1-positive population. The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoint of OS and data were immature at time of analysis. OS follow-up is planned to continue until final analysis. Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified. In the previous IMpassion130 study, Tecentriq in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension [albumin-bound]; nab-paclitaxel) demonstrated a statistically significant PFS benefit and, while not formally tested, showed clinically meaningful improvements in OS for people with metastatic TNBC and whose tumors express PD-L1 (?1%). Tecentriq in combination with nab-paclitaxel is approved under accelerated approval by the FDA for the treatment of adults with unresectable locally advanced or metastatic TNBC and whose tumors express PD-L1 (?1%). Full results from IMpassion131 are being discussed with global health authorities and will be presented at a future medical meeting. The insights will also be used to inform existing and future studies in TNBC with Tecentriq in combination with paclitaxel.