Tecentriq combo with paclitaxel misses in triple-negative breast cancer trial

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.

Marketed by Swiss pharma giant Roche (ROG: SIX), Tecentriq was first approved in 2016, and posted sales of around $1.4 billion, +74%, in the first half of this year,

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 (atezolizumab) 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 whose tumors express PD-L1 (≥1%). Tecentriq in combination with nab-paclitaxel is approved in over 70 countries for the treatment of adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (≥1%).

Results underscore the need to better understand the cancer and immune system interactions