Atezolizumab + nab-paclitaxel as first line therapy in Japanese patients with TNBC: A subgroup analysis of IMpassion130

Abstract

Abstract Background IMpassion130 is randomized, double-blind, phase III study to evaluate efficacy and safety of atezolizumab (ATZ)+nab-paclitaxel (nPTX) vs placebo (Pla)+nPTX in patients (pts) with treatment-naive locally advanced or metastatic triple-negative breast cancer (TNBC). We report the results of Japanese subgroup. Methods Pts were randomized 1:1 to Pla or ATZ (840 mg, q2w)+nPTX (100 mg/m2, 3 weeks on/1 week off). Progression-free survival (PFS) and overall survival (OS) as co-primary endpoints were assessed in intent-to-treat population and programmed death-ligand 1 positive (PD-L1+) population. Results Among 902 enrolled pts, sixty five pts were from Japan (34 pts with ATZ+nPTX, 12 of them PD-L1+; 31 pts Pla+nPTX, 13 of them PD-L1+). Median PFS was 7.4 months (mo) in ATZ+nPTX, as compared with 4.6 mo in Pla+nPTX [hazard ratio (HR), 0.47; 95% confidence interval (CI), 0.25-0.90]. In the PD-L1+ population (n = 25), median PFS was 10.8 mo in ATZ+nPTX, as compared with 3.8 mo in Pla+nPTX (HR, 0.04; 95%CI, Conclusion The efficacy and safety of ATZ+nPTX as first line therapy in Japanese pts with TNBC were consistent with those of overall study population.