The phase III IMpassion031 study, evaluating Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [albumin-bound paclitaxel, nab-paclitaxel]; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy (including Abraxane), met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response for the treatment of people with early triple-negative breast cancer, regardless of PD-L1 expression.
Tecentriq is sponsored by Genentech, a member of the Roche Group.
In the study, fewer patients who received the Tecentriq combination as a neoadjuvant (before surgery) treatment had evidence of tumor tissue detectable at the time of surgery, regardless of PD-L1 expression, in comparison to the control arm.
Safety for the Tecentriq combination appeared to be consistent with the known safety profiles of the individual medicines and no new safety signals were identified.
The IMpassion031 study is the second positive phase III study from Genentech demonstrating the benefit of Tecentriq in TNBC, and the first Tecentriq study to demonstrate benefit in early TNBC. Tecentriq in combination with nab-paclitaxel is approved in more than 70 countries, including the U.S. and across Europe, for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumors express PD-L1 (IC≥1%).
