Atezolizumab is effective and well tolerated in pretreated advanced/metastatic nonesmall-cell lung cancer (NSCLC). We examined atezolizumab's efficacy and safety in 64 Japanese patients with NSCLC in the same setting via a subanalysis of the phase 3 OAK study. Atezolizumab improved overall survival versus docetaxel and was generally well tolerated, thus offering a potential NSCLC treatment for Japanese patients. Introduction: Atezolizumab, an antieprogrammed death-ligand 1 (PD-L1) agent, is

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... ctive and well tolerated in patients with pretreated advanced nonesmall-cell lung cancer (NSCLC). We assessed its efficacy and safety in Japanese patients through subgroup analyses of the phase 3 OAK study (NCT02008227). Patients and Methods: Key eligibility criteria of this randomized, controlled, open-label, international study include locally advanced/metastatic NSCLC, 1 prior platinum-based chemotherapy, age 18 years, measurable disease (Response Evaluation Criteria in Solid Tumors v1.1), and Eastern Cooperative Oncology Group performance status 0 or 1. Atezolizumab 1200 mg or docetaxel 75 mg/m 2 was provided intravenously every 3 weeks. Co-primary end points were overall survival (OS) in the intention-to-treat (ITT) population and those with 1% PD-L1 expression on tumor cells (TC) or tumor-infiltrating immune cells (IC; TC1/2/3 or IC1/2/3). Results: Sixty-four ITT patients were Japanese; 19 had TC1/2/3 or IC1/2/3 status. In Japanese ITT patients, median OS in the atezolizumab arm (n ¼ 36) was longer than the docetaxel arm (n ¼ 28; 21.3 months [95% confidence interval (CI), 11.0-not estimable (NE)] versus 17.0 months [95% CI, 12.5-NE], respectively; hazard ratio 0.80 [95% CI, 0.41-1.57]). In the TC1/2/3 or IC1/2/3 population, median OS was 21.3 months (95% CI, 15.0-NE) and NE in the atezolizumab (n ¼ 11) and docetaxel (n ¼ 8) groups, respectively (hazard ratio, 0.81 [95% CI, 0.22-3.05]). Atezolizumab was generally well tolerated, with no treatment-related deaths. Conclusion: Atezolizumab was effective and well tolerated in pretreated Japanese patients with NSCLC. Results are consistent with the primary analysis of OAK.