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Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non–Small-Cell Lung Cancer in CheckMate 227
Open accessAbstract
PURPOSE: We present 5-year results from CheckMate 227 Part 1, in which nivolumab plus ipilimumab improved overall survival (OS) versus chemotherapy in patients with metastatic non–small-cell lung cancer, regardless of tumor programmed death ligand 1 (PD-L1) status. METHODS: Adults with stage IV/recurrent non–small-cell lung cancer without EGFR mutations or ALK alterations and with tumor PD-L1 ≥ 1% or < 1% (n = 1739) were randomly assigned. Patients with tumor PD-L1 ≥ 1% were randomly assigned to first-line nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. Patients with tumor PD-L1 < 1% were randomly assigned to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy. End points included exploratory 5-year results for efficacy, safety, and quality of life. RESULTS: At a minimum follow-up of 61.3 months, 5-year OS rates were 24% versus 14% for nivolumab plus ipilimumab versus chemotherapy (PD-L1 ≥ 1%) and 19% versus 7% (PD-L1 < 1%). The median duration of response was 24.5 versus 6.7 months (PD-L1 ≥ 1%) and 19.4 versus 4.8 months (PD-L1 < 1%). Among patients surviving 5 years, 66% (PD-L1 ≥ 1%) and 64% (PD-L1 < 1%) were off nivolumab plus ipilimumab without initiating subsequent systemic anticancer treatment by the 5-year time point. Survival benefit continued after nivolumab plus ipilimumab discontinuation because of treatment-related adverse events, with a 5-year OS rate of 39% (combined PD-L1 ≥ 1% and < 1% populations). Quality of life in 5-year survivors treated with nivolumab plus ipilimumab was similar to that in the general US population through the 5-year follow-up. No new safety signals were observed. CONCLUSION: With all patients off immunotherapy treatment for ≥ 3 years, nivolumab plus ipilimumab increased 5-year survivorship versus chemotherapy, including long-term, durable clinical benefit regardless of tumor PD-L1 expression. These data support nivolumab plus ipilimumab as an effective first-line treatment for patients with metastatic non–small-cell lung cancer. [Media: see text]
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Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden
Hellmann, M. D., Ciuleanu, T.-E., Pluzanski, A., Lee, J. S., Otterson, G. A., Audigier-Valette, C., Minenza, E., Linardou, H., Burgers, S., Salman, P., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1801946 · Cited by 3,063
Self-citationNivolumab plus ipilimumab in advanced non-small-cell lung cancer
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Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer
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Neoadjuvant immune checkpoint blockade: A window of opportunity to advance cancer immunotherapy
Topalian, S. L., Forde, P. M., Emens, L. A., Yarchoan, M., Smith, K. N., & Pardoll, D. M. (2023) · Cancer Cell · doi:10.1016/j.ccell.2023.07.011 · Cited by 317
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Holder, A. M., Dedeilia, A., Sierra-Davidson, K., Cohen, S., Liu, D., Parikh, A., & Boland, G. M. (2024) · Nature Reviews Cancer · doi:10.1038/s41568-024-00705-7 · Cited by 298
André, T., Elez, E., Lenz, H.-J., Jensen, L. H., Touchefeu, Y., Van Cutsem, E., Garcia-Carbonero, R., Tougeron, D., Mendez, G. A., Schenker, M., et al. (2025) · The Lancet · doi:10.1016/s0140-6736(24)02848-4 · Cited by 256
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Metadata
- Authors
- Brahmer, J. R., Lee, J.-S., Ciuleanu, T.-E., Bernabe Caro, R., Nishio, M., Urban, L., Audigier-Valette, C., Lupinacci, L., Sangha, R., Pluzanski, A., Burgers, J., Mahave, M., Ahmed, S., Schoenfeld, A. J., Paz-Ares, L. G., Reck, M., Borghaei, H., O'Byrne, K. J., Gupta, R. G., Bushong, J., Li, L., Blum, S. I., Eccles, L. J., & Ramalingam, S. S.
- Venue
- Journal of Clinical Oncology
- Published
- 2023-02-20
- Volume
- 41
- Issue
- 6
- Pages
- 1200-1212
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W4304807333
- Cited by
- 406
- References
- 24
- FWCI
- 29.36
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Brahmer, J. R., Lee, J.-S., Ciuleanu, T.-E., Bernabe Caro, R., Nishio, M., Urban, L., Audigier-Valette, C., Lupinacci, L., Sangha, R., Pluzanski, A., Burgers, J., Mahave, M., Ahmed, S., Schoenfeld, A. J., Paz-Ares, L. G., Reck, M., Borghaei, H., O'Byrne, K. J., Gupta, R. G., . . . Ramalingam, S. S. (2023). Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non–Small-Cell Lung Cancer in CheckMate 227. Journal of Clinical Oncology. https://doi.org/10.1200/jco.22.01503
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