Tecentriq plus Abraxane for Advanced or Metastatic Triple-Negative Breast Cancer with PD-L1 Expression

April 2019, Vol 10, No 2 - FDA Approvals, News & Updates


On March 1, 2019, the FDA accelerated the approval of atezolizumab (Tecentriq; Genentech) plus nab-paclitaxel (Abraxane; Celgene) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and PD-L1 expression, as identified by an FDA-approved test. Tecentriq was previously approved for bladder cancer and for non–small-cell lung cancer. This is the first FDA approval of an immunotherapy for patients with metastatic TNBC.

The FDA approval of this new indication was based on results of a clinical trial of 902 treatment-naïve patients with metastatic TNBC who were randomized to the immunochemotherapy combination with atezolizumab plus nab-paclitaxel or to placebo plus nab-paclitaxel. The median progression-free survival (PFS) was 7.2 months in the immunochemotherapy arm versus 5.5 months in the chemotherapy-alone arm; among patients with tumors expressing PD-L1, the median PFS was 7.5 months and 5.0 months, respectively.

The most common (≥20%) adverse events in this study were alopecia, peripheral neuropathy, fatigue, nausea, diarrhea, anemia, constipation, cough, headache, neutropenia, vomiting, and decreased appetite.