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Research Article|Articles in Press, 100484

Effectiveness and safety of atezolizumab monotherapy in previously treated Japanese patients with unresectable advanced or recurrent non-small cell lung cancer: A multicenter, prospective, observational study (J-TAIL)

Open AccessPublished:February 24, 2023DOI:https://doi.org/10.1016/j.jtocrr.2023.100484
Effectiveness and safety of atezolizumab monotherapy in previously treated Japanese patients with unresectable advanced or recurrent non-small cell lung cancer: A multicenter, prospective, observational study (J-TAIL)
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      Abstract

      Introduction

      The efficacy and safety of atezolizumab in previously treated patients with non-small cell lung cancer (NSCLC) have been established in the registrational phase III OAK trial. In this study, we evaluated the effectiveness and safety of atezolizumab monotherapy in a large real-world cohort to confirm the reproducibility of the results of the registrational trial.

      Methods

      This was a multicenter, prospective, single-arm observational study. Consecutive patients with previously treated NSCLC scheduled to receive atezolizumab monotherapy were enrolled. The primary endpoint was the 18-month overall survival (OS) rate. The incidence of adverse events (AEs) and immune-related AEs (irAEs) was evaluated.

      Results

      Overall, 1002 patients were included in the safety analysis set and 1000 in the full analysis set (FAS). Median follow-up was 11.5 months. Of the FAS, 62% were ineligible for the OAK trial (OAK-unlike subpopulation). The 18-month OS rate was 41.1%, with a median OS of 13.0 months (95% confidence interval [CI], 12.2–15.1). The 18-month OS rate was 49.4% and 36.1% in OAK-like and OAK-unlike subpopulations, respectively; that in patients with Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2 was 14.3%. The incidence of AEs overall, in the OAK-like, and OAK-unlike subpopulations was 43.9%, 46.2%, and 42.5%; that of irAEs was 19.0%, 20.1%, and 18.3%, respectively.

      Conclusions

      The findings suggest atezolizumab may be effective and safe for previously treated patients with NSCLC in real-world settings; however, atezolizumab administration should be considered carefully regarding the benefit–risk balance for the OAK-unlike subpopulation, especially in patients with ECOG PS ≥2.

      Keywords

      Article info

      Publication history

      Accepted: February 16, 2023
      Received in revised form: January 19, 2023
      Received: October 3, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      CRediT Authorship Contribution Statement

      Satoru Miura: Conceptualization, Resources, Investigation, Visualization, Writing–original draft, Writing–review and editing.

      Makoto Nishio: Conceptualization, Resources, Supervision, Investigation, Writing–review and editing.

      Hiroaki Akamatsu: Conceptualization, Resources, Investigation, Writing–review and editing.

      Yasushi Goto: Conceptualization, Resources, Investigation, Writing–review and editing.

      Hidetoshi Hayashi: Conceptualization, Resources, Investigation, Writing–review and editing.

      Akihiko Gemma: Conceptualization, Resources, Supervision, Funding acquisition, Investigation, Writing–review and editing.

      Ichiro Yoshino: Conceptualization, Resources, Investigation, Writing–review and editing.

      Toshihiro Misumi: Formal analysis, Writing–review and editing.

      Akito Hata: Resources, Investigation, Writing–review and editing.

      Osamu Hataji: Resources, Investigation, Writing–review and editing.

      Kohei Fujita: Resources, Investigation, Writing–review and editing.

      Masahiro Seike: Resources, Investigation, Writing–review and editing.

      Noriko Yanagitani: Resources, Investigation, Writing–review and editing

      Kazumi Nishino: Resources, Investigation, Writing–review and editing.

      Satoshi Hara: Resources, Investigation, Writing–review and editing.

      Ryota Saito: Resources, Investigation, Writing–review and editing.

      Masahide Mori: Resources, Investigation, Writing–review and editing.

      Takeshi Tsuda: Resources, Investigation, Writing–review and editing.

      Shunichiro Iwasawa: Conceptualization, Visualization, Writing–original draft, Project administration, Writing–review and editing.

      Shintaro Nakagawa: Formal analysis, Writing–review and editing.

      Tetsuya Mitsudomi: Conceptualization, Resources, Supervision, Funding acquisition, Investigation, Visualization, Project administration, Writing–review and editing.

      Disclosure of Funding

      This study was funded by Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.

      Conflict of Interest Statement

      Satoru Miura reports honoraria from Chugai Pharma, Taiho Pharma, Eli Lilly, Boehringer-Ingelheim, Ono Pharma, AstraZeneca, MSD, and Bristol-Myers Squibb. Makoto Nishio reports payment/honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Pfizer, Chugai Pharmaceutical, Eli Lilly, Taiho Pharmaceutical, AstraZeneca, Boehringer-Ingelheim, MSD, Novartis, Sankyo Healthcare, Taiho Pharmaceutical, Merck Serono, and Astellas. Hiroaki Akamatsu reports research funding from Amgen, Chugai Pharmaceutical Co. Ltd., and MSD K.K.; honoraria from AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Bristol-Myers Squibb, Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Nippon Kayaku Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Pfizer Inc., and Taiho Pharmaceutical Co. Ltd.; and an advisory board membership for Amgen Inc., and Janssen Pharmaceutical K.K. Yasushi Goto reports grants or contracts to the clinical trial group from AstraZeneca K.K, and Pfizer; grants or contracts to own institution from Abbvie, Eli Lilly, Pfizer, Bristol Myers Squibb, Ono, Novartis, Kyorin, Daiichi Sankyo, Novartis, and Prefered Network; payment/honoraria from Eli Lilly, Chugai, Taiho, Boehringer Ingelheim, Ono, Bristol Myers Squibb, Pfizer, MSD, Novartis, Merck, and Thermo Fisher; participation on a data safety monitoring board or advisory board for AstraZeneca, Chugai, Boehringer Ingelheim, Eli Lilly, Taiho, Pfizer, Novartis, Guardant Health Inc., Illumina, Daiichi Sankyo, Ono Pharmaceutical, Bristol Myers Squibb, and MSD; and a leadership or fiduciary role in other board, society, committee or advocacy group for Cancer Net Japan, and JAMT. Hidetoshi Hayashi reports grants or contracts from AstraZeneca K.K., Astellas Pharma Inc., MSD K.K., Ono Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Pfizer Japan Inc., Bristol Myers Squibb Company, Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Merck Serono Co., Ltd./ Merck Biopharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Limited, AbbVie Inc., inVentiv Health Japan, ICON Japan K.K., GRITSONE ONCOLOGY Inc., PAREXEL International Corp., Kissei Pharmaceutical Co., Ltd., EPS Corporation, Syneos Health, Pfizer R&D Japan G.K., A2 Healthcare Corp., Quintiles Inc./IQVIA Services Japan K.K., EP-CRSU Co., Ltd., Linical Co., Ltd., Eisai Co., Ltd., CMIC Shift Zero K.K., Kyowa Hakko Kirin Co., Ltd., Bayer Yakuhin Ltd., EPS International Co., Ltd., and Otsuka Pharmaceutical Co., Ltd.; and payment/honoraria from Amgen K.K, AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Bristol-Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Guardant Healthcare, Kyorin Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., MSD K.K., Novartis Pharmaceuticals K.K., Ono Pharmaceutical Co., Ltd., Shanghai Haihe Biopharm, Taiho Pharmaceutical Co., Ltd., Pfizer, and Takeda Pharmaceutical Co., Ltd. Akihiko Gemma reports lecture fees from Chugai Pharmaceutical Co., Ltd. Ichiro Yoshino reports lecture fees/advisory fees from Chugai Pharmaceutical, Intuitive Surgical, AstraZeneca, Johnson and Johnson and Covidien Japan, grants/lecture fees from TAIHO Pharmaceutical and Dai-ichi Sankyo Chemical Pharma, and lecture fees from Japan Blood Products Organization, Astellas, Bristol-Meyers Squibb, Shionogi Pharmaceutical, Eli Lilly, CSL Behring, MSD, Ono pharmaceutical and Care Net, advisory fee from Medicaroid, and grants from Pfizer. Toshihiro Misumi reports grants or contracts to own institution from Chugai Pharmaceutical Co., Ltd. Akito Hata reports grants or contracts from MSD, Eli Lilly, Boehringer Ingelheim, and AstraZeneca; and payment/honoraria from Eli Lilly, Chugai, Pfizer, AstraZeneca, and Boehringer Ingelheim. Osamu Hataji reports grants or contracts from AstraZeneca, Novartis Pharma, MSD, Daiichi Sankyo Company Limited, Bayer Yakuhin, AbbVie, Eli Lilly, Janssen Pharmaceutical K.K, and Ono Pharmaceutical; and payment/honoraria from AstraZeneca, Chugai Pharmaceutical, Takeda Pharmaceutical, MSD, Merck KGaA, Daiichi Sankyo Company Limited, Eli Lilly, AbbVie, Boehringer Ingelheim, Nippon Kayaku, and Taiho Pharmaceutical. Masahiro Seike reports research funding from Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical, MSD K.K., Nippon Boehringer Ingelheim, and Eli Lilly; and honoraria for lectures from Chugai Pharmaceutical Co., Ltd., AstraZeneca, MSD K.K., Taiho Pharmaceutical, Eli Lilly, Ono Pharmaceutical, Bristol-Myers Squibb, Nippon Boehringer Ingelheim, Kyowa Hakko Kirin, Daiichi-Sankyo Company, Novartis, and Nippon Kayaku. Noriko Yanagitani reports payment/honoraria from Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, Pfizer Inc., Eli Lilly and Company, AstraZeneca plc, Takeda Pharmaceutical Company Limited, and Bayer Yakuhin Ltd.; and payment for expert testimony from Chugai Pharmaceutical Co., Ltd. Kazumi Nishino reports grants or contracts to own institution from, ONO PHARMACEUTICAL CO., LTD., TAIHO PHARMACEUTICAL CO., LTD., MSD, AbbVie, DAIICHI SANKYO COMPANY LIMITED, Amgen, Eisai Co., Ltd., Eli Lilly Japan, Nippon Boehringer Ingelheim, Pfizer, Takeda Pharmaceutical Company Limited, Merck, Janssen Pharmaceutical K.K., and AstraZeneca; and honoraria for lectures from Eli Lilly Japan, Nippon Boehringer Ingelheim, Novartis, Pfizer, Takeda Pharmaceutical Company Limited, Merck, Janssen Pharmaceutical K.K., Bristol Myers Squibb, Nippon Kayaku, and AstraZeneca. Masahide Mori reports research funding from Chugai, Ono, MSD, and Delta-fly; and lecture fees from AstraZeneca, Boehringer Ingelheim, MSD, Eli Lilly, Novartis, Chugai, Taiho, Kyowa-Kirin, Ono Pharmaceutical, Otsuka, Nihon-kayaku, Pfizer, Daiichi Sankyo, Takeda, and Shionogi. Takeshi Tsuda reports honoraria from Chugai Pharmaceutical Co., Ltd. Shunichiro Iwasawa reports honoraria for lectures from Chugai Pharmaceutical Co., Ltd., Bristol-Myers Squibb Company, Ono Pharmaceutical Co., Ltd., and AstraZeneca K.K; and is an employee of Chugai Pharmaceutical Co., Ltd. Shintaro Nakagawa is an employee of Chugai Pharmaceutical Co., Ltd. Tetsuya Mitsudomi reports grants or contracts from Ono Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, and MSD; consulting fees from Ono Pharmaceutical, BMS, MSD, Chugai, and AstraZeneca; and payment/honoraria from Ono Pharmaceutical, BMS, MSD, Chugai, and AstraZeneca. Kohei Fujita, Satoshi Hara, and Ryota Saito declare no potential conflicts of interest.

      Identification

      DOI: https://doi.org/10.1016/j.jtocrr.2023.100484

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      © 2023 Published by Elsevier Inc. on behalf of the International Association for the Study of Lung Cancer.

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