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First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1
BACKGROUND: In CheckMate 227 Part 1 (NCT02477826), first-line nivolumab plus ipilimumab demonstrated long-term durable overall survival (OS) benefit versus chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC), regardless of tumor programmed death ligand 1 (PD-L1) expression. W...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Nature Singapore
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10542710/ https://www.ncbi.nlm.nih.gov/pubmed/37548831 http://dx.doi.org/10.1007/s10147-023-02390-2 |
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author | Nishio, Makoto Ohe, Yuichiro Ikeda, Satoshi Yokoyama, Toshihide Hayashi, Hidetoshi Fukuhara, Tatsuro Sato, Yuki Tanaka, Hiroshi Hotta, Katsuyuki Sugawara, Shunichi Daga, Haruko Okamoto, Isamu Kasahara, Kazuo Naito, Tateaki Li, Li Gupta, Ravi G. Bushong, Judith Mizutani, Hideaki |
author_facet | Nishio, Makoto Ohe, Yuichiro Ikeda, Satoshi Yokoyama, Toshihide Hayashi, Hidetoshi Fukuhara, Tatsuro Sato, Yuki Tanaka, Hiroshi Hotta, Katsuyuki Sugawara, Shunichi Daga, Haruko Okamoto, Isamu Kasahara, Kazuo Naito, Tateaki Li, Li Gupta, Ravi G. Bushong, Judith Mizutani, Hideaki |
author_sort | Nishio, Makoto |
collection | PubMed |
description | BACKGROUND: In CheckMate 227 Part 1 (NCT02477826), first-line nivolumab plus ipilimumab demonstrated long-term durable overall survival (OS) benefit versus chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC), regardless of tumor programmed death ligand 1 (PD-L1) expression. We report results in Japanese patients with ≥ 5-year follow-up. METHODS: Adults with stage IV/recurrent NSCLC without EGFR/ALK aberrations were randomized 1:1:1 to nivolumab plus ipilimumab, nivolumab alone, or chemotherapy (patients with tumor PD-L1 ≥ 1%), or nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (patients with tumor PD-L1 < 1%). Five-year efficacy and safety were assessed in Japanese patients. RESULTS: At 62.1 months’ minimum follow-up, 143 Japanese patients with PD-L1 ≥ 1% or < 1% were randomized to nivolumab plus ipilimumab (n = 66) or chemotherapy (n = 77). Five-year OS rates were 46% with nivolumab plus ipilimumab versus 34% with chemotherapy (PD-L1 ≥ 1%) and 36% versus 19% (PD-L1 < 1%). Median duration of response was 59.1 versus 7.1 months (PD-L1 ≥ 1%) and 17.3 versus 3.0 months (PD-L1 < 1%). Among 5-year survivors treated with nivolumab plus ipilimumab (PD-L1 ≥ 1% and < 1%; n = 27), 59% (95% CI, 39%–75%) were off treatment for ≥ 3 years without receiving subsequent therapy. No new safety signals were observed. CONCLUSIONS: At 5-year follow-up, nivolumab plus ipilimumab continued to show long-term durable clinical benefit versus chemotherapy, regardless of tumor PD-L1 expression. Consistent with findings for the global population, these data support the use of nivolumab plus ipilimumab as first-line treatment in Japanese patients with metastatic NSCLC. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10147-023-02390-2. |
format | Online Article Text |
id | pubmed-10542710 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer Nature Singapore |
record_format | MEDLINE/PubMed |
spelling | pubmed-105427102023-10-03 First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1 Nishio, Makoto Ohe, Yuichiro Ikeda, Satoshi Yokoyama, Toshihide Hayashi, Hidetoshi Fukuhara, Tatsuro Sato, Yuki Tanaka, Hiroshi Hotta, Katsuyuki Sugawara, Shunichi Daga, Haruko Okamoto, Isamu Kasahara, Kazuo Naito, Tateaki Li, Li Gupta, Ravi G. Bushong, Judith Mizutani, Hideaki Int J Clin Oncol Original Article BACKGROUND: In CheckMate 227 Part 1 (NCT02477826), first-line nivolumab plus ipilimumab demonstrated long-term durable overall survival (OS) benefit versus chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC), regardless of tumor programmed death ligand 1 (PD-L1) expression. We report results in Japanese patients with ≥ 5-year follow-up. METHODS: Adults with stage IV/recurrent NSCLC without EGFR/ALK aberrations were randomized 1:1:1 to nivolumab plus ipilimumab, nivolumab alone, or chemotherapy (patients with tumor PD-L1 ≥ 1%), or nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (patients with tumor PD-L1 < 1%). Five-year efficacy and safety were assessed in Japanese patients. RESULTS: At 62.1 months’ minimum follow-up, 143 Japanese patients with PD-L1 ≥ 1% or < 1% were randomized to nivolumab plus ipilimumab (n = 66) or chemotherapy (n = 77). Five-year OS rates were 46% with nivolumab plus ipilimumab versus 34% with chemotherapy (PD-L1 ≥ 1%) and 36% versus 19% (PD-L1 < 1%). Median duration of response was 59.1 versus 7.1 months (PD-L1 ≥ 1%) and 17.3 versus 3.0 months (PD-L1 < 1%). Among 5-year survivors treated with nivolumab plus ipilimumab (PD-L1 ≥ 1% and < 1%; n = 27), 59% (95% CI, 39%–75%) were off treatment for ≥ 3 years without receiving subsequent therapy. No new safety signals were observed. CONCLUSIONS: At 5-year follow-up, nivolumab plus ipilimumab continued to show long-term durable clinical benefit versus chemotherapy, regardless of tumor PD-L1 expression. Consistent with findings for the global population, these data support the use of nivolumab plus ipilimumab as first-line treatment in Japanese patients with metastatic NSCLC. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10147-023-02390-2. Springer Nature Singapore 2023-08-07 2023 /pmc/articles/PMC10542710/ /pubmed/37548831 http://dx.doi.org/10.1007/s10147-023-02390-2 Text en © The Author(s) 2023, corrected publication 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Article Nishio, Makoto Ohe, Yuichiro Ikeda, Satoshi Yokoyama, Toshihide Hayashi, Hidetoshi Fukuhara, Tatsuro Sato, Yuki Tanaka, Hiroshi Hotta, Katsuyuki Sugawara, Shunichi Daga, Haruko Okamoto, Isamu Kasahara, Kazuo Naito, Tateaki Li, Li Gupta, Ravi G. Bushong, Judith Mizutani, Hideaki First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1 |
title | First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1 |
title_full | First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1 |
title_fullStr | First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1 |
title_full_unstemmed | First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1 |
title_short | First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1 |
title_sort | first-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in japanese patients from checkmate 227 part 1 |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10542710/ https://www.ncbi.nlm.nih.gov/pubmed/37548831 http://dx.doi.org/10.1007/s10147-023-02390-2 |
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