Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer.

Abstract (PubMed)

BACKGROUND: Unresectable locally advanced or metastatic triple-negative breast cancer is an aggressive disease with poor outcomes. Nanoparticle albumin-bound (nab)-paclitaxel may enhance the anticancer activity of atezolizumab. METHODS: In this phase 3 trial, we randomly assigned (1:1) patients with untreated metastatic triple-negative breast cancer to receive atezolizumab plus nab-paclitaxel or placebo plus nab-paclitaxel. Stratification: receipt of neoadjuvant/adjuvant taxane, liver metastases, PD-L1 expression. RESULTS: Each group included 451 patients (median follow-up 12.9 months). ITT: median progression-free survival 7.2 months with atezolizumab+nab-paclitaxel vs 5.5 months placebo+nab-paclitaxel (HR 0.80; 95% CI 0.69-0.92; P=0.002). PD-L1-positive subgroup: 7.5 vs 5.0 months (HR 0.62). CONCLUSIONS: Atezolizumab plus nab-paclitaxel prolonged progression-free survival in metastatic TNBC, in both ITT and PD-L1-positive subgroup. Adverse events consistent with known safety profiles. (Funded by F. Hoffmann-La Roche/Genentech; IMpassion130 NCT02425891.).