Conditional survival and long‐term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma

Background Conditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and conditional survival outcomes were assessed in CheckMate 214 (ClinicalTrials.gov identifier NCT02231749) with a minimum follow‐up of 5 years...

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Veröffentlicht in:	Cancer Jg. 128; H. 11; S. 2085 - 2097
Hauptverfasser:	Motzer, Robert J., McDermott, David F., Escudier, Bernard, Burotto, Mauricio, Choueiri, Toni K., Hammers, Hans J., Barthélémy, Philippe, Plimack, Elizabeth R., Porta, Camillo, George, Saby, Powles, Thomas, Donskov, Frede, Gurney, Howard, Kollmannsberger, Christian K., Grimm, Marc‐Oliver, Barrios, Carlos, Tomita, Yoshihiko, Castellano, Daniel, Grünwald, Viktor, Rini, Brian I., McHenry, M. Brent, Lee, Chung‐Wei, McCarthy, Jennifer, Ejzykowicz, Flavia, Tannir, Nizar M.
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States Wiley Subscription Services, Inc 01.06.2022
Schlagworte:	advanced renal cell carcinoma Antineoplastic Combined Chemotherapy Protocols - adverse effects Apoptosis Body mass Body mass index Body size Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - pathology CheckMate 214 dual checkpoint inhibition durable response Estimates Female Humans Immune checkpoint Immunotherapy Inhibitor drugs Ipilimumab Kidney cancer Kidney Neoplasms - drug therapy Kidney Neoplasms - pathology long‐term follow‐up Male Metastases Monoclonal antibodies Nivolumab - therapeutic use nivolumab plus ipilimumab Oncology Patients phase 3 Renal cell carcinoma Risk Sunitinib Survival Targeted cancer therapy Tumors durable response phase 3 long-term follow-up dual checkpoint inhibition nivolumab plus ipilimumab CheckMate 214 advanced renal cell carcinoma
ISSN:	0008-543X, 1097-0142, 1097-0142
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Abstract	Background Conditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and conditional survival outcomes were assessed in CheckMate 214 (ClinicalTrials.gov identifier NCT02231749) with a minimum follow‐up of 5 years. Methods Patients with untreated aRCC were randomized to receive nivolumab (NIVO) (3 mg/kg) plus ipilimumab (IPI) (1 mg/kg) every 3 weeks for 4 cycles, then either NIVO monotherapy or sunitinib (SUN) (50 mg) daily (four 6‐week cycles). Efficacy was assessed in intent‐to‐treat, International Metastatic Renal Cell Carcinoma Database Consortium intermediate‐risk/poor‐risk, and favorable‐risk populations. Conditional survival outcomes (the probability of remaining alive, progression free, or in response 2 years beyond a specified landmark) were analyzed. Results The median follow‐up was 67.7 months; overall survival (median, 55.7 vs 38.4 months; hazard ratio, 0.72), progression‐free survival (median, 12.3 vs 12.3 months; hazard ratio, 0.86), and objective response (39.3% vs 32.4%) benefits were maintained with NIVO+IPI versus SUN, respectively, in intent‐to‐treat patients (N = 550 vs 546). Point estimates for 2‐year conditional overall survival beyond the 3‐year landmark were higher with NIVO+IPI versus SUN (intent‐to‐treat patients, 81% vs 72%; intermediate‐risk/poor‐risk patients, 79% vs 72%; favorable‐risk patients, 85% vs 72%). Conditional progression‐free survival and response point estimates were also higher beyond 3 years with NIVO+IPI. Point estimates for conditional overall survival were higher or remained steady at each subsequent year of survival with NIVO+IPI in patients stratified by tumor programmed death ligand 1 expression, grade ≥3 immune‐mediated adverse event experience, body mass index, and age. Conclusions Durable clinical benefits were observed with NIVO+IPI versus SUN at 5 years, the longest phase 3 follow‐up for a first‐line checkpoint inhibitor‐based combination in patients with aRCC. Conditional estimates indicate that most patients who remained alive or in response with NIVO+IPI at 3 years remained so at 5 years. In the longest phase 3 follow‐up of a checkpoint inhibitor combination therapy in advanced renal cell carcinoma together with the first long‐term conditional survival analyses in the CheckMate 214 trial, nivolumab plus ipilimumab demonstrated durable survival and response benefits versus sunitinib at 5 years. These results establish a new benchmark for both the magnitude and durability of benefit possible with first‐line immunotherapy‐based regimens in this setting.
AbstractList	BackgroundConditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and conditional survival outcomes were assessed in CheckMate 214 (ClinicalTrials.gov identifier NCT02231749) with a minimum follow‐up of 5 years.MethodsPatients with untreated aRCC were randomized to receive nivolumab (NIVO) (3 mg/kg) plus ipilimumab (IPI) (1 mg/kg) every 3 weeks for 4 cycles, then either NIVO monotherapy or sunitinib (SUN) (50 mg) daily (four 6‐week cycles). Efficacy was assessed in intent‐to‐treat, International Metastatic Renal Cell Carcinoma Database Consortium intermediate‐risk/poor‐risk, and favorable‐risk populations. Conditional survival outcomes (the probability of remaining alive, progression free, or in response 2 years beyond a specified landmark) were analyzed.ResultsThe median follow‐up was 67.7 months; overall survival (median, 55.7 vs 38.4 months; hazard ratio, 0.72), progression‐free survival (median, 12.3 vs 12.3 months; hazard ratio, 0.86), and objective response (39.3% vs 32.4%) benefits were maintained with NIVO+IPI versus SUN, respectively, in intent‐to‐treat patients (N = 550 vs 546). Point estimates for 2‐year conditional overall survival beyond the 3‐year landmark were higher with NIVO+IPI versus SUN (intent‐to‐treat patients, 81% vs 72%; intermediate‐risk/poor‐risk patients, 79% vs 72%; favorable‐risk patients, 85% vs 72%). Conditional progression‐free survival and response point estimates were also higher beyond 3 years with NIVO+IPI. Point estimates for conditional overall survival were higher or remained steady at each subsequent year of survival with NIVO+IPI in patients stratified by tumor programmed death ligand 1 expression, grade ≥3 immune‐mediated adverse event experience, body mass index, and age.ConclusionsDurable clinical benefits were observed with NIVO+IPI versus SUN at 5 years, the longest phase 3 follow‐up for a first‐line checkpoint inhibitor‐based combination in patients with aRCC. Conditional estimates indicate that most patients who remained alive or in response with NIVO+IPI at 3 years remained so at 5 years. Conditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and conditional survival outcomes were assessed in CheckMate 214 (ClinicalTrials.gov identifier NCT02231749) with a minimum follow-up of 5 years.BACKGROUNDConditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and conditional survival outcomes were assessed in CheckMate 214 (ClinicalTrials.gov identifier NCT02231749) with a minimum follow-up of 5 years.Patients with untreated aRCC were randomized to receive nivolumab (NIVO) (3 mg/kg) plus ipilimumab (IPI) (1 mg/kg) every 3 weeks for 4 cycles, then either NIVO monotherapy or sunitinib (SUN) (50 mg) daily (four 6-week cycles). Efficacy was assessed in intent-to-treat, International Metastatic Renal Cell Carcinoma Database Consortium intermediate-risk/poor-risk, and favorable-risk populations. Conditional survival outcomes (the probability of remaining alive, progression free, or in response 2 years beyond a specified landmark) were analyzed.METHODSPatients with untreated aRCC were randomized to receive nivolumab (NIVO) (3 mg/kg) plus ipilimumab (IPI) (1 mg/kg) every 3 weeks for 4 cycles, then either NIVO monotherapy or sunitinib (SUN) (50 mg) daily (four 6-week cycles). Efficacy was assessed in intent-to-treat, International Metastatic Renal Cell Carcinoma Database Consortium intermediate-risk/poor-risk, and favorable-risk populations. Conditional survival outcomes (the probability of remaining alive, progression free, or in response 2 years beyond a specified landmark) were analyzed.The median follow-up was 67.7 months; overall survival (median, 55.7 vs 38.4 months; hazard ratio, 0.72), progression-free survival (median, 12.3 vs 12.3 months; hazard ratio, 0.86), and objective response (39.3% vs 32.4%) benefits were maintained with NIVO+IPI versus SUN, respectively, in intent-to-treat patients (N = 550 vs 546). Point estimates for 2-year conditional overall survival beyond the 3-year landmark were higher with NIVO+IPI versus SUN (intent-to-treat patients, 81% vs 72%; intermediate-risk/poor-risk patients, 79% vs 72%; favorable-risk patients, 85% vs 72%). Conditional progression-free survival and response point estimates were also higher beyond 3 years with NIVO+IPI. Point estimates for conditional overall survival were higher or remained steady at each subsequent year of survival with NIVO+IPI in patients stratified by tumor programmed death ligand 1 expression, grade ≥3 immune-mediated adverse event experience, body mass index, and age.RESULTSThe median follow-up was 67.7 months; overall survival (median, 55.7 vs 38.4 months; hazard ratio, 0.72), progression-free survival (median, 12.3 vs 12.3 months; hazard ratio, 0.86), and objective response (39.3% vs 32.4%) benefits were maintained with NIVO+IPI versus SUN, respectively, in intent-to-treat patients (N = 550 vs 546). Point estimates for 2-year conditional overall survival beyond the 3-year landmark were higher with NIVO+IPI versus SUN (intent-to-treat patients, 81% vs 72%; intermediate-risk/poor-risk patients, 79% vs 72%; favorable-risk patients, 85% vs 72%). Conditional progression-free survival and response point estimates were also higher beyond 3 years with NIVO+IPI. Point estimates for conditional overall survival were higher or remained steady at each subsequent year of survival with NIVO+IPI in patients stratified by tumor programmed death ligand 1 expression, grade ≥3 immune-mediated adverse event experience, body mass index, and age.Durable clinical benefits were observed with NIVO+IPI versus SUN at 5 years, the longest phase 3 follow-up for a first-line checkpoint inhibitor-based combination in patients with aRCC. Conditional estimates indicate that most patients who remained alive or in response with NIVO+IPI at 3 years remained so at 5 years.CONCLUSIONSDurable clinical benefits were observed with NIVO+IPI versus SUN at 5 years, the longest phase 3 follow-up for a first-line checkpoint inhibitor-based combination in patients with aRCC. Conditional estimates indicate that most patients who remained alive or in response with NIVO+IPI at 3 years remained so at 5 years. In the longest phase 3 follow‐up of a checkpoint inhibitor combination therapy in advanced renal cell carcinoma together with the first long‐term conditional survival analyses in the CheckMate 214 trial, nivolumab plus ipilimumab demonstrated durable survival and response benefits versus sunitinib at 5 years. These results establish a new benchmark for both the magnitude and durability of benefit possible with first‐line immunotherapy‐based regimens in this setting. Background Conditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and conditional survival outcomes were assessed in CheckMate 214 (ClinicalTrials.gov identifier NCT02231749) with a minimum follow‐up of 5 years. Methods Patients with untreated aRCC were randomized to receive nivolumab (NIVO) (3 mg/kg) plus ipilimumab (IPI) (1 mg/kg) every 3 weeks for 4 cycles, then either NIVO monotherapy or sunitinib (SUN) (50 mg) daily (four 6‐week cycles). Efficacy was assessed in intent‐to‐treat, International Metastatic Renal Cell Carcinoma Database Consortium intermediate‐risk/poor‐risk, and favorable‐risk populations. Conditional survival outcomes (the probability of remaining alive, progression free, or in response 2 years beyond a specified landmark) were analyzed. Results The median follow‐up was 67.7 months; overall survival (median, 55.7 vs 38.4 months; hazard ratio, 0.72), progression‐free survival (median, 12.3 vs 12.3 months; hazard ratio, 0.86), and objective response (39.3% vs 32.4%) benefits were maintained with NIVO+IPI versus SUN, respectively, in intent‐to‐treat patients (N = 550 vs 546). Point estimates for 2‐year conditional overall survival beyond the 3‐year landmark were higher with NIVO+IPI versus SUN (intent‐to‐treat patients, 81% vs 72%; intermediate‐risk/poor‐risk patients, 79% vs 72%; favorable‐risk patients, 85% vs 72%). Conditional progression‐free survival and response point estimates were also higher beyond 3 years with NIVO+IPI. Point estimates for conditional overall survival were higher or remained steady at each subsequent year of survival with NIVO+IPI in patients stratified by tumor programmed death ligand 1 expression, grade ≥3 immune‐mediated adverse event experience, body mass index, and age. Conclusions Durable clinical benefits were observed with NIVO+IPI versus SUN at 5 years, the longest phase 3 follow‐up for a first‐line checkpoint inhibitor‐based combination in patients with aRCC. Conditional estimates indicate that most patients who remained alive or in response with NIVO+IPI at 3 years remained so at 5 years. In the longest phase 3 follow‐up of a checkpoint inhibitor combination therapy in advanced renal cell carcinoma together with the first long‐term conditional survival analyses in the CheckMate 214 trial, nivolumab plus ipilimumab demonstrated durable survival and response benefits versus sunitinib at 5 years. These results establish a new benchmark for both the magnitude and durability of benefit possible with first‐line immunotherapy‐based regimens in this setting. Conditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and conditional survival outcomes were assessed in CheckMate 214 (ClinicalTrials.gov identifier NCT02231749) with a minimum follow-up of 5 years. Patients with untreated aRCC were randomized to receive nivolumab (NIVO) (3 mg/kg) plus ipilimumab (IPI) (1 mg/kg) every 3 weeks for 4 cycles, then either NIVO monotherapy or sunitinib (SUN) (50 mg) daily (four 6-week cycles). Efficacy was assessed in intent-to-treat, International Metastatic Renal Cell Carcinoma Database Consortium intermediate-risk/poor-risk, and favorable-risk populations. Conditional survival outcomes (the probability of remaining alive, progression free, or in response 2 years beyond a specified landmark) were analyzed. The median follow-up was 67.7 months; overall survival (median, 55.7 vs 38.4 months; hazard ratio, 0.72), progression-free survival (median, 12.3 vs 12.3 months; hazard ratio, 0.86), and objective response (39.3% vs 32.4%) benefits were maintained with NIVO+IPI versus SUN, respectively, in intent-to-treat patients (N = 550 vs 546). Point estimates for 2-year conditional overall survival beyond the 3-year landmark were higher with NIVO+IPI versus SUN (intent-to-treat patients, 81% vs 72%; intermediate-risk/poor-risk patients, 79% vs 72%; favorable-risk patients, 85% vs 72%). Conditional progression-free survival and response point estimates were also higher beyond 3 years with NIVO+IPI. Point estimates for conditional overall survival were higher or remained steady at each subsequent year of survival with NIVO+IPI in patients stratified by tumor programmed death ligand 1 expression, grade ≥3 immune-mediated adverse event experience, body mass index, and age. Durable clinical benefits were observed with NIVO+IPI versus SUN at 5 years, the longest phase 3 follow-up for a first-line checkpoint inhibitor-based combination in patients with aRCC. Conditional estimates indicate that most patients who remained alive or in response with NIVO+IPI at 3 years remained so at 5 years.
Author	Hammers, Hans J. George, Saby Castellano, Daniel Barthélémy, Philippe Choueiri, Toni K. Ejzykowicz, Flavia Barrios, Carlos Porta, Camillo Donskov, Frede Gurney, Howard Burotto, Mauricio Motzer, Robert J. Plimack, Elizabeth R. Tomita, Yoshihiko Powles, Thomas McHenry, M. Brent Grünwald, Viktor Tannir, Nizar M. Rini, Brian I. McDermott, David F. Kollmannsberger, Christian K. Escudier, Bernard McCarthy, Jennifer Lee, Chung‐Wei Grimm, Marc‐Oliver
Author_xml	– sequence: 1 givenname: Robert J. orcidid: 0000-0001-6925-2327 surname: Motzer fullname: Motzer, Robert J. email: motzerr@mskcc.org organization: Memorial Sloan Kettering Cancer Center – sequence: 2 givenname: David F. surname: McDermott fullname: McDermott, David F. organization: Beth Israel Deaconess Medical Center, Dana‐Farber/Harvard Cancer Center – sequence: 3 givenname: Bernard surname: Escudier fullname: Escudier, Bernard organization: Gustave Roussy – sequence: 4 givenname: Mauricio surname: Burotto fullname: Burotto, Mauricio organization: Bradford Hill Clinical Research Center – sequence: 5 givenname: Toni K. orcidid: 0000-0002-9201-3217 surname: Choueiri fullname: Choueiri, Toni K. organization: Brigham and Women's Hospital, and Harvard Medical School – sequence: 6 givenname: Hans J. surname: Hammers fullname: Hammers, Hans J. organization: University of Texas Southwestern Kidney Cancer Program – sequence: 7 givenname: Philippe surname: Barthélémy fullname: Barthélémy, Philippe organization: Strasbourg European Cancer Institute – sequence: 8 givenname: Elizabeth R. surname: Plimack fullname: Plimack, Elizabeth R. organization: Fox Chase Cancer Center – sequence: 9 givenname: Camillo surname: Porta fullname: Porta, Camillo organization: University of Pavia – sequence: 10 givenname: Saby surname: George fullname: George, Saby organization: Roswell Park Cancer Institute – sequence: 11 givenname: Thomas surname: Powles fullname: Powles, Thomas organization: Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Center, Queen Mary University of London, Royal Free National Health Service Trust – sequence: 12 givenname: Frede surname: Donskov fullname: Donskov, Frede organization: Aarhus University Hospital – sequence: 13 givenname: Howard surname: Gurney fullname: Gurney, Howard organization: Westmead Hospital and Macquarie University – sequence: 14 givenname: Christian K. surname: Kollmannsberger fullname: Kollmannsberger, Christian K. organization: British Columbia Cancer Agency – sequence: 15 givenname: Marc‐Oliver surname: Grimm fullname: Grimm, Marc‐Oliver organization: Jena University Hospital – sequence: 16 givenname: Carlos surname: Barrios fullname: Barrios, Carlos organization: Pontifical Catholic University of Rio Grande do Sul – sequence: 17 givenname: Yoshihiko surname: Tomita fullname: Tomita, Yoshihiko organization: Niigata University Graduate School of Medical and Dental Sciences – sequence: 18 givenname: Daniel surname: Castellano fullname: Castellano, Daniel organization: Cancer Network Biomedical Research Center – sequence: 19 givenname: Viktor surname: Grünwald fullname: Grünwald, Viktor organization: West German Cancer Center Clinic for Internal Medicine and Clinic for Urology, University Hospital Essen – sequence: 20 givenname: Brian I. surname: Rini fullname: Rini, Brian I. organization: Vanderbilt University Medical Center – sequence: 21 givenname: M. Brent surname: McHenry fullname: McHenry, M. Brent organization: Bristol Myers Squibb – sequence: 22 givenname: Chung‐Wei surname: Lee fullname: Lee, Chung‐Wei organization: Bristol Myers Squibb – sequence: 23 givenname: Jennifer surname: McCarthy fullname: McCarthy, Jennifer organization: Bristol Myers Squibb – sequence: 24 givenname: Flavia surname: Ejzykowicz fullname: Ejzykowicz, Flavia organization: Bristol Myers Squibb – sequence: 25 givenname: Nizar M. surname: Tannir fullname: Tannir, Nizar M. organization: The University of Texas MD Anderson Cancer Center
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Keywords	durable response phase 3 long-term follow-up dual checkpoint inhibition nivolumab plus ipilimumab CheckMate 214 advanced renal cell carcinoma
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Notes	The authors received no financial support or compensation for the publication of this article. See referenced editorial on pages 2058–2060 this issue. We thank the patients who participated in this study, the clinical study teams, and the representatives of the sponsor who were involved in data collection and analyses. Medical writing support was provided by Rachel Maddente, PhD, of Parexel, and was funded by Bristol Myers Squibb. Correction added on 26 April 2022, after first online publication: Figures 1‐3 have been updated in this version. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 ObjectType-Undefined-3
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References	2020; 8 2020; 5 2013; 14 2019; 20 2010; 116 1999; 17 2018; 378 2019; 25 2008; 109 2020; 16 2021; 384 2017; 376 2012; 13 2019; 380 2010; 9 e_1_2_9_11_1 e_1_2_9_10_1 e_1_2_9_13_1 e_1_2_9_12_1 e_1_2_9_8_1 e_1_2_9_7_1 e_1_2_9_6_1 e_1_2_9_5_1 e_1_2_9_4_1 e_1_2_9_3_1 e_1_2_9_2_1 e_1_2_9_9_1 e_1_2_9_15_1 e_1_2_9_14_1 e_1_2_9_16_1 35383907 - Cancer. 2022 Jun 1;128(11):2058-2060. doi: 10.1002/cncr.34177.
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Snippet	Background Conditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and... In the longest phase 3 follow‐up of a checkpoint inhibitor combination therapy in advanced renal cell carcinoma together with the first long‐term conditional... Conditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and... BackgroundConditional survival estimates provide critical prognostic information for patients with advanced renal cell carcinoma (aRCC). Efficacy, safety, and...
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SubjectTerms	advanced renal cell carcinoma Antineoplastic Combined Chemotherapy Protocols - adverse effects Apoptosis Body mass Body mass index Body size Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - pathology CheckMate 214 dual checkpoint inhibition durable response Estimates Female Humans Immune checkpoint Immunotherapy Inhibitor drugs Ipilimumab Kidney cancer Kidney Neoplasms - drug therapy Kidney Neoplasms - pathology long‐term follow‐up Male Metastases Monoclonal antibodies Nivolumab - therapeutic use nivolumab plus ipilimumab Oncology Patients phase 3 Renal cell carcinoma Risk Sunitinib Survival Targeted cancer therapy Tumors
Title	Conditional survival and long‐term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma
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