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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Vydané v:Cancer Ročník 128; číslo 11; s. 2085 - 2097
Hlavní autori: 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.
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: United States Wiley Subscription Services, Inc 01.06.2022
Predmet:
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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Shrnutí: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.
Bibliografia: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.
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ISSN:0008-543X
1097-0142
1097-0142
DOI:10.1002/cncr.34180