Atezolizumab in Japanese Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer

A Subgroup Analysis of the Phase 3 OAK Study

Toyoaki Hida, Reiko Kaji, Miyako Satouchi, Norihiko Ikeda, Atsushi Horiike, Hiroshi Nokihara, Takashi Seto, Tomohisa Kawakami, Shintaro Nakagawa, Toshio Kubo

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Abstract

Atezolizumab is effective and well tolerated in pretreated advanced/metastatic non–small-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 anti–programmed death-ligand 1 (PD-L1) agent, is effective and well tolerated in patients with pretreated advanced non–small-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/m2 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 = 36) was longer than the docetaxel arm (n = 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 = 11) and docetaxel (n = 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.

Original languageEnglish
Pages (from-to)e405-e415
JournalClinical Lung Cancer
Volume19
Issue number4
DOIs
Publication statusPublished - Jul 1 2018

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Non-Small Cell Lung Carcinoma
docetaxel
Confidence Intervals
Survival
Safety
MPDL3280A
Cytotoxic T-Lymphocytes
Platinum
Population
Neoplasms
Ligands
Drug Therapy
Therapeutics

Keywords

  • Anti–PD-L1
  • Cancer immunotherapy
  • Docetaxel
  • Japan
  • TECENTRIQ

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Atezolizumab in Japanese Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer : A Subgroup Analysis of the Phase 3 OAK Study. / Hida, Toyoaki; Kaji, Reiko; Satouchi, Miyako; Ikeda, Norihiko; Horiike, Atsushi; Nokihara, Hiroshi; Seto, Takashi; Kawakami, Tomohisa; Nakagawa, Shintaro; Kubo, Toshio.

In: Clinical Lung Cancer, Vol. 19, No. 4, 01.07.2018, p. e405-e415.

Research output: Contribution to journalArticle

Hida, T, Kaji, R, Satouchi, M, Ikeda, N, Horiike, A, Nokihara, H, Seto, T, Kawakami, T, Nakagawa, S & Kubo, T 2018, 'Atezolizumab in Japanese Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study', Clinical Lung Cancer, vol. 19, no. 4, pp. e405-e415. https://doi.org/10.1016/j.cllc.2018.01.004
Hida, Toyoaki ; Kaji, Reiko ; Satouchi, Miyako ; Ikeda, Norihiko ; Horiike, Atsushi ; Nokihara, Hiroshi ; Seto, Takashi ; Kawakami, Tomohisa ; Nakagawa, Shintaro ; Kubo, Toshio. / Atezolizumab in Japanese Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer : A Subgroup Analysis of the Phase 3 OAK Study. In: Clinical Lung Cancer. 2018 ; Vol. 19, No. 4. pp. e405-e415.
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abstract = "Atezolizumab is effective and well tolerated in pretreated advanced/metastatic non–small-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 anti–programmed death-ligand 1 (PD-L1) agent, is effective and well tolerated in patients with pretreated advanced non–small-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/m2 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 = 36) was longer than the docetaxel arm (n = 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 = 11) and docetaxel (n = 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.",
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AU - Satouchi, Miyako

AU - Ikeda, Norihiko

AU - Horiike, Atsushi

AU - Nokihara, Hiroshi

AU - Seto, Takashi

AU - Kawakami, Tomohisa

AU - Nakagawa, Shintaro

AU - Kubo, Toshio

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N2 - Atezolizumab is effective and well tolerated in pretreated advanced/metastatic non–small-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 anti–programmed death-ligand 1 (PD-L1) agent, is effective and well tolerated in patients with pretreated advanced non–small-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/m2 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 = 36) was longer than the docetaxel arm (n = 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 = 11) and docetaxel (n = 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.

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