Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non–Small-Cell Lung Cancer in CheckMate 227. Brahmer, J. R., Lee, J., Ciuleanu, T., 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. Journal of Clinical Oncology, 41(6):1200–1212, February, 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 [link]Paper  doi  abstract   bibtex   
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 \textless 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 \textless 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 \textless 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 \textless 1%). Among patients surviving 5 years, 66% (PD-L1 ≥ 1%) and 64% (PD-L1 \textless 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 \textless 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]
@article{brahmer_five-year_2023,
	title = {Five-{Year} {Survival} {Outcomes} {With} {Nivolumab} {Plus} {Ipilimumab} {Versus} {Chemotherapy} as {First}-{Line} {Treatment} for {Metastatic} {Non}–{Small}-{Cell} {Lung} {Cancer} in {CheckMate} 227},
	volume = {41},
	issn = {0732-183X, 1527-7755},
	url = {https://ascopubs.org/doi/10.1200/JCO.22.01503},
	doi = {10.1200/JCO.22.01503},
	abstract = {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 {\textless} 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 {\textless} 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 {\textless} 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 {\textless} 1\%). Among patients surviving 5 years, 66\% (PD-L1 ≥ 1\%) and 64\% (PD-L1 {\textless} 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 {\textless} 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]},
	language = {en},
	number = {6},
	urldate = {2024-12-06},
	journal = {Journal of Clinical Oncology},
	author = {Brahmer, Julie R. and Lee, Jong-Seok and Ciuleanu, Tudor-Eliade and Bernabe Caro, Reyes and Nishio, Makoto and Urban, Laszlo and Audigier-Valette, Clarisse and Lupinacci, Lorena and Sangha, Randeep and Pluzanski, Adam and Burgers, Jacobus and Mahave, Mauricio and Ahmed, Samreen and Schoenfeld, Adam J. and Paz-Ares, Luis G. and Reck, Martin and Borghaei, Hossein and O'Byrne, Kenneth J. and Gupta, Ravi G. and Bushong, Judith and Li, Li and Blum, Steven I. and Eccles, Laura J. and Ramalingam, Suresh S.},
	month = feb,
	year = {2023},
	pages = {1200--1212},
}
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