Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer

Basel, 06 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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 (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 tumours 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 tumours express PD-L1 (≥1%).

“While we are disappointed by the results from the IMpassion131 study, we are grateful for all the patients, families and physicians who were involved in the study," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "Today’s results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens. We remain committed to finding optimal treatments for all people living with this aggressive disease.”

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 triple-negative breast cancer with Tecentriq in combination with paclitaxel.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.