TY - JOUR
T1 - Five-Year Survival Outcomes with Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non-Small-Cell Lung Cancer in CheckMate 227
AU - Brahmer, Julie R.
AU - Lee, Jong Seok
AU - Ciuleanu, Tudor Eliade
AU - Bernabe Caro, Reyes
AU - Nishio, Makoto
AU - Urban, Laszlo
AU - Audigier-Valette, Clarisse
AU - Lupinacci, Lorena
AU - Sangha, Randeep
AU - Pluzanski, Adam
AU - Burgers, Jacobus
AU - Mahave, Mauricio
AU - Ahmed, Samreen
AU - Schoenfeld, Adam J.
AU - Paz-Ares, Luis G.
AU - Reck, Martin
AU - Borghaei, Hossein
AU - O'Byrne, Kenneth J.
AU - Gupta, Ravi G.
AU - Bushong, Judith
AU - Li, Li
AU - Blum, Steven I.
AU - Eccles, Laura J.
AU - Ramalingam, Suresh S.
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/2/20
Y1 - 2023/2/20
N2 - PURPOSEWe 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.METHODSAdults 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.RESULTSAt 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.CONCLUSIONWith 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.
AB - PURPOSEWe 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.METHODSAdults 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.RESULTSAt 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.CONCLUSIONWith 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.
KW - Adult
KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
KW - B7-H1 Antigen/metabolism
KW - Carcinoma, Non-Small-Cell Lung/genetics
KW - Humans
KW - Ipilimumab/therapeutic use
KW - Lung Neoplasms/genetics
KW - Neoplasm Recurrence, Local/drug therapy
KW - Nivolumab/therapeutic use
KW - Quality of Life
UR - http://www.scopus.com/inward/record.url?scp=85148249894&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:000970386000009&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.1200/JCO.22.01503
DO - 10.1200/JCO.22.01503
M3 - Article
C2 - 36223558
SN - 0732-183X
VL - 41
SP - 1200
EP - 1212
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 6
ER -
