FDA grants accelerated approval for Tecentriq + Abraxane in metastatic triple-negative breast cancer

Genentech/Roche announced the FDA has granted accelerated approval to Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Originally filed in late 2018, this accelerated approval is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 40 percent compared with nab- paclitaxel alone (median PFS=7.4 vs. 4.8 months; HR=0.60, 95% CI: 0.48-0.77, p<0.0001) in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. Overall survival (OS) results were immature with 43 percent of events in all randomized patients (intent-to-treat; ITT), and further data will be shared with the FDA and presented at an upcoming medical meeting.

Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The most common Grade 3-4 side effects (at most 2 percent) with Tecentriq plus nab-paclitaxel were low white blood cells, tingling or numbness in the hands and feet, neutrophil count decreased, feeling tired, low red blood cells, low blood potassium level, pneumonia and increased blood level of a liver enzyme (AST). The most common side effects (at least 20 percent) were hair loss, feeling tired, tingling or numbness in the hands and feet, nausea, diarrhea, low red blood cells, constipation, cough, headache, low white blood cells, decreased appetite and vomiting.