Roche has reported that the combination of Tecentriq (atezolizumab) plus paclitaxel (chemotherapy) failed to meet the primary goal in the Phase III IMpassion131 clinical trial for PD-L1-positive metastatic triple-negative breast cancer (TNBC).
Compared to placebo plus paclitaxel as a first-line treatment, Tecentriq plus paclitaxel did not achieve statistical significance on the primary endpoint of progression-free survival (PFS).
Roche added that results for the secondary endpoint of overall survival (OS) revealed a negative trend. The study was not powered for the OS measure and findings were immature at the time of analysis.
The plan is to continue OS follow-up until final analysis.
Safety for the Tecentriq combination was observed to be consistent with the known profile of the individual drugs, without any new safety signals.
Roche chief medical officer and Global Product Development head Levi Garraway said: “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.
“Today’s results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens.”
In the previous IMpassion130 trial, Tecentriq in combination with Abraxane (paclitaxel; nab-paclitaxel) showed a statistically significant PFS benefit.
Tecentriq plus nab-paclitaxel holds approval in more than 70 countries to treat adults with unresectable locally advanced or metastatic TNBC whose tumours express PD-L1.
Roche is discussing the full results from IMpassion131 with global health authorities. The insights will be used to inform existing and future trials of Tecentriq plus paclitaxel in triple-negative breast cancer.
The company is evaluating Tecentriq as a monotherapy and combination treatment across various lung, skin, breast, gastrointestinal, gynaecological and head and neck cancers.
Last month, Roche reported that its Actemra drug failed to meet the primary endpoint of improved clinical status in the Phase III COVACTA trial for severe Covid-19-related pneumonia.