Clinical Trial

. 2024 Nov;35(11):1026-1038.

doi: 10.1016/j.annonc.2024.07.727. Epub 2024 Aug 2.

Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 8-year follow-up results of efficacy and safety from the phase III CheckMate 214 trial

N M Tannir¹, L Albigès², D F McDermott³, M Burotto⁴, T K Choueiri⁵, H J Hammers⁶, P Barthélémy⁷, E R Plimack⁸, C Porta⁹, S George¹⁰, F Donskov¹¹, M B Atkins¹², H Gurney¹³, C K Kollmannsberger¹⁴, M-O Grimm¹⁵, C Barrios¹⁶, Y Tomita¹⁷, D Castellano¹⁸, V Grünwald¹⁹, B I Rini²⁰, R Jiang²¹, H Desilva²², V Fedorov²³, C-W Lee²⁴, R J Motzer²⁵

Affiliations

¹ Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: ntannir@mdanderson.org.
² Department of Medical Oncology (Département de Médecine Oncologique), Gustave Roussy, Villejuif, France.
³ Division of Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, USA.
⁴ Department of Oncology, Bradford Hill Clinical Research Center, Santiago, Chile.
⁵ Department of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston; Harvard Medical School, Boston.
⁶ Department Internal Medicine, UT Southwestern Kidney Cancer Program, Dallas, USA.
⁷ Department of Medical Oncology, Medical Oncology Unit, Institut de Cancérologie Strasbourg Europe, Strasbourg, France.
⁸ Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, USA.
⁹ Department of Internal Medicine, University of Pavia, Pavia, Italy.
¹⁰ Department of Medicine, Roswell Park Cancer Institute, Buffalo, USA.
¹¹ Department of Oncology, Aarhus University Hospital, Aarhus; University Hospital of Southern Denmark, Esbjerg, Denmark.
¹² Department of Oncology, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.
¹³ Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, Australia.
¹⁴ Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, Canada.
¹⁵ Department of Urology, Jena University Hospital and Comprehensive Cancer Center Central Germany (CCCG), Campus Jena, Jena, Germany.
¹⁶ Department of Internal Medicine and Oncology Research Center, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.
¹⁷ Departments of Urology and Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
¹⁸ Medical Oncology Department, University Hospital 12 de Octubre, CIBER-ONC, Madrid, Spain.
¹⁹ Interdisciplinary Genitourinary Oncology, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, West-German Cancer Center Essen, University Hospital Essen, Essen, Germany.
²⁰ Department of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center, Nashville.
²¹ Global Biometrics and Data Sciences, Bristol Myers Squibb, Princeton.
²² Late Clinical Development, Bristol Myers Squibb, Princeton.
²³ Oncology Late Clinical Development, Bristol Myers Squibb, Princeton.
²⁴ Department of Clinical Trials, Bristol Myers Squibb, Princeton.
²⁵ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.

PMID: 39098455
PMCID: PMC11907766
DOI: 10.1016/j.annonc.2024.07.727

Clinical Trial

Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 8-year follow-up results of efficacy and safety from the phase III CheckMate 214 trial

N M Tannir et al. Ann Oncol. 2024 Nov.

. 2024 Nov;35(11):1026-1038.

doi: 10.1016/j.annonc.2024.07.727. Epub 2024 Aug 2.

Authors

Affiliations

¹ Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: ntannir@mdanderson.org.
² Department of Medical Oncology (Département de Médecine Oncologique), Gustave Roussy, Villejuif, France.
³ Division of Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, USA.
⁴ Department of Oncology, Bradford Hill Clinical Research Center, Santiago, Chile.
⁵ Department of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston; Harvard Medical School, Boston.
⁶ Department Internal Medicine, UT Southwestern Kidney Cancer Program, Dallas, USA.
⁷ Department of Medical Oncology, Medical Oncology Unit, Institut de Cancérologie Strasbourg Europe, Strasbourg, France.
⁸ Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, USA.
⁹ Department of Internal Medicine, University of Pavia, Pavia, Italy.
¹⁰ Department of Medicine, Roswell Park Cancer Institute, Buffalo, USA.
¹¹ Department of Oncology, Aarhus University Hospital, Aarhus; University Hospital of Southern Denmark, Esbjerg, Denmark.
¹² Department of Oncology, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC, USA.
¹³ Department of Medical Oncology, Westmead Hospital and Macquarie University, Sydney, Australia.
¹⁴ Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, Canada.
¹⁵ Department of Urology, Jena University Hospital and Comprehensive Cancer Center Central Germany (CCCG), Campus Jena, Jena, Germany.
¹⁶ Department of Internal Medicine and Oncology Research Center, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.
¹⁷ Departments of Urology and Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
¹⁸ Medical Oncology Department, University Hospital 12 de Octubre, CIBER-ONC, Madrid, Spain.
¹⁹ Interdisciplinary Genitourinary Oncology, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, West-German Cancer Center Essen, University Hospital Essen, Essen, Germany.
²⁰ Department of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center, Nashville.
²¹ Global Biometrics and Data Sciences, Bristol Myers Squibb, Princeton.
²² Late Clinical Development, Bristol Myers Squibb, Princeton.
²³ Oncology Late Clinical Development, Bristol Myers Squibb, Princeton.
²⁴ Department of Clinical Trials, Bristol Myers Squibb, Princeton.
²⁵ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.

PMID: 39098455
PMCID: PMC11907766
DOI: 10.1016/j.annonc.2024.07.727

Abstract

Background: Nivolumab plus ipilimumab (NIVO+IPI) has demonstrated superior overall survival (OS) and durable response benefits versus sunitinib (SUN) with long-term follow-up in patients with advanced renal cell carcinoma (aRCC). We report updated analyses with 8 years of median follow-up from CheckMate 214.

Patients and methods: Patients with aRCC (N = 1096) were randomized to NIVO 3 mg/kg plus IPI 1 mg/kg Q3W × four doses, followed by NIVO (3 mg/kg or 240 mg Q2W or 480 mg Q4W); or SUN (50 mg) once daily for 4 weeks on, 2 weeks off. The endpoints included OS, independent radiology review committee (IRRC)-assessed progression-free survival (PFS), and IRRC-assessed objective response rate (ORR) in intermediate/poor-risk (I/P; primary), intent-to-treat (ITT; secondary), and favorable-risk (FAV; exploratory) patients.

Results: With 8 years (99.1 months) of median follow-up, the hazard ratio [HR; 95% confidence interval (CI)] for OS with NIVO+IPI versus SUN was 0.72 (0.62-0.83) in ITT patients, 0.69 (0.59-0.81) in I/P patients, and 0.82 (0.60-1.13) in FAV patients. PFS probabilities at 90 months were 22.8% versus 10.8% (ITT), 25.4% versus 8.5% (I/P), and 12.7% versus 17.0% (FAV), respectively. ORR with NIVO+IPI versus SUN was 39.5% versus 33.0% (ITT), 42.4% versus 27.5% (I/P), and 29.6% versus 51.6% (FAV). Rates of complete response were higher with NIVO+IPI versus SUN in all International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups (ITT, 12.0% versus 3.5%; I/P, 11.8% versus 2.6%; FAV, 12.8% versus 6.5%). The median duration of response (95% CI) with NIVO+IPI versus SUN was 76.2 versus 25.1 months [59.1 months-not estimable (NE) versus 19.8-33.2 months] in ITT patients, 82.8 versus 19.8 months (54.1 months-NE versus 16.4-26.4 months) in I/P patients, and 61.5 versus 33.2 months (27.8 months-NE versus 24.8-51.4 months) in FAV patients. The incidence of treatment-related adverse events was consistent with previous reports. Exploratory post hoc analyses are reported for FAV patients, those receiving subsequent therapy based on their response status, clinical subpopulations, and adverse events over time.

Conclusions: Superior survival, durable response benefits, and a manageable safety profile were maintained with NIVO+IPI versus SUN at 8 years, the longest phase III follow-up for a first-line checkpoint inhibitor combination therapy in aRCC.

Keywords: CheckMate 214; Nivolumab, ipilimumab; advanced renal cell carcinoma; dual checkpoint inhibition; long-term follow-up; phase III.

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Conflict of interest statement

NMT reports consulting or advisory roles with Oncorena, Merck Sharp & Dohme, Bristol Myers Squibb (BMS) Foundation, and Nektar; stock ownership with AbbVie, Amgen, Arcturus, Arcus Biosciences, Astra Zeneca, BioCryst Pharmaceutical, Coherus BioSciences, Corvus Pharmaceuticals, CVS Health, Gilead Sciences, GSK, Johnson & Johnson/Janssen, Medtronic, Merck, Pfizer, Pyxis Oncology, Surface Oncology, Vanguard Health Care ETF, Werewolf Therapeutics, Xencor, First Trust Amex Biotech (FBT), Nuvation Bio Inc. Revolution Medicines, and SPDR S&P Pharmaceuticals ETF; honoraria from BMS, Exelixis, Eisai Medical Research, Neoleukin Therapeutics, Merck Sharp & Dohme, Intellisphere, Oncorena, AstraZeneca/Merck, and Nektar Therapeutics; and research funding to institution from Exelixis, BMS, Nektar, Arrowhead Pharmaceuticals, Novartis, and Calithera Biosciences.

LA reports consulting or advisory roles to institution with Astellas, BMS, Eisai, Ipsen, Janssen, MSD, Novartis, Pfizer, and Roche; honoraria from Novartis; non-financial interests as principal investigator with Pfizer, BMS, Ipsen, AVEO, AstraZeneca, and MSD; membership with ASCO; membership in the Renal Cell Carcinoma Guidelines Panel, which is part of the European Association of Urology; and being on the Clinical Trial Steering Committee for Roche and Exelixis.

DFM reports consulting or advisory roles with BMS, Merck, Genentech/Roche, Pfizer, Exelixis, Novartis, Array BioPharma, Peloton Therapeutics, EMD Serono, Jounce Therapeutics, Alkermes, Lilly, Eisai, Calithera Biosciences, Iovance Biotherapeutics, Werewolf Therapeutics, Synthekine, AVEO, Xilio Therapeutics, and Cullinan Oncology; research funding to institution from BMS, Merck, Genentech, Novartis, and Alkermes; and employment with Beth Israel Deaconess Medical Center.

MB reports consulting or advisory roles with Roche/Genentech, BMS, MSD Oncology, Novartis, and AstraZeneca; and speakers’ bureau with Roche/Genentech, MSD Oncology, BMS, and AstraZeneca.

TKC reports medical writing support outside the submitted work with Alkermes, AstraZeneca, Aravive, AVEO, Bayer, BMS, Calithera, Circle Pharma, Deciphera Pharmaceuticals, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, Gilead, HiberCell, IQVIA, Infinity, Ipsen, Janssen, Kanaph, Lilly, Merck, NiKang, Neomorph, Nuscan/PrecedeBio, Novartis, OncoHost, Pfizer, Roche, Sanofi/Aventis, Scholar Rock, Surface Oncology, Takeda, Tempest, Up-To-Date, CME events (PeerView, OncLive, MJH, CCO, and others); consulting or advisory roles outside the submitted work with Alkermes, AstraZeneca, Aravive, AVEO, Bayer, BMS, Calithera, Circle Pharma, Deciphera Pharmaceuticals, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, Gilead, HiberCell, IQVIA, Infinity, Ipsen, Janssen, Kanaph, Lilly, Merck, NiKang, Neomorph, Nuscan/PrecedeBio, Novartis, OncoHost, Pfizer, Roche, Sanofi/Aventis, Scholar Rock, Surface Oncology, Takeda, Tempest, Up-To-Date, CME events (Peerview, OncLive, MJH, CCO, and others); honoraria and/or transport and meals related to meetings, lectures, and advisory boards from Alkermes, AstraZeneca, Aravive, Aveo, Bayer, BMS, Calithera, Circle Pharma, Deciphera Pharmaceuticals, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, Gilead, HiberCell, IQVIA, Infinity, Ipsen, Jansen, Kanaph, Lilly, Merck, NiKang, Neomorph, Nuscan/PrecedeBio, Novartis, OncoHost, Pfizer, Roche, Sanofi/Aventis, Scholar Rock, Surface Oncology, Takeda, Tempest, Up-To-Date, CME events (Peerview, OncLive, MJH, CCO, and others); participation on a data safety monitoring board with Aravive; leadership role with KindeyCan (non-financial), and committees for ASCO/ESMO/NCCN/GU Steering Committee of the NCI; stock ownership with Pionyr, Tempest, Precede Bio, Osel, Curesponse, Immdura, and Primium; other financial interests with support in part by the Dana-Farber/Harvard Cancer Center Kidney SPORE (2P50CA101942-16) and Program 5P30CA006516-56, the Kohlberg Chair at Harvard Medical School and the Trust Family, Michael Brigham, Pan-Mass Challenge, Hinda and Arthur Marcus Fund and Loker Pinard Funds for Kidney Cancer Research at DFCI.

HJH reports consulting or advisory roles with BMS, Pfizer, Exelixis, Bayer, Novartis, Merck, ARMO BioSiences, Corvus Pharmaceuticals, Surface Oncology, and Lilly; travel, accommodations, expenses from BMS, Merck, Pfizer, Lilly, and Novartis; honoraria from BMS; and research funding to institution from BMS, Merck, Aravive, and Surface Oncology.

PB reports consulting or advisory roles with Ipsen, BMS, MSD Oncology, Pfizer, Janssen-Cilag, AstraZeneca, Amgen, Merck KGaA, Eisai, Gilead Sciences, Bayer, and AAA/Endoctye/Novartis; travel, accommodations, expenses from BMS, Pfizer, Janssen-Cilag, MSD, Ipsen, and Merck/Pfizer; honoraria from BMS, MSD, Astellas Pharma, Janssen-Cilag, Pfizer, Merck KGaA, Novartis, Seagen, Ipsen, Gilead Sciences, and Bayer.

ERP reports consulting or advisory roles with Seattle Genetics/Astellas, AstraZeneca, AVEO, BMS/Medarex, Calithera Biosciences, EMD Serono, Exelixis, IMV, Janssen, MEI Pharma, Merck, Signatera, Pfizer, and Regeneron; and research funding to institution from BMS, Merck, Sharp & Dohme, Astellas Pharma, and Genentech/Roche.

CP reports consulting or advisory roles with Angelini Pharma, AstraZeneca, BMS, Eisai, Ipsen, and MSD; and honoraria from Angelini Pharma, AstraZeneca, BMS, Eisai, Ipsen, and MSD.

SG reports consulting or advisory roles with BMS, Bayer, Pfizer, Exelixis, Corvus Pharmaceuticals, Sanofi, EMD Serono, Seattle Genetics/Astellas, Eisai, Merck, AVEO, and QED Therapeutics; travel, accommodations, expenses from BMS/Medarex and Sanofi; and research funding to institution from Pfizer, Merck, Agensys, Novartis, BMS, Bayer, Eisai, Seattle Genetics/Astellas, Surface Oncology, Exelixis, Aravive, AVEO, and Gilead Sciences.

FD reports no conflicts of interest.

MBA reports consulting or advisory roles with Genentech, Novartis, BMS, Merck, Exelixis, Eisai, Agenus, Werewolf Pharma, Surface Oncology, Pyxis, Fathom Biotechnology, AVEO, AstraZeneca, Pfizer, Scholar Rock, Asher Biotherapeutics, Takeda, Sanofi, Simcha Therapeutics, GlaxoSmithKline, Oncorena, and Pliant; stock and other ownership interests with Werewolf Pharma and Pyxis; and research funding to institution from BMS and Merck.

HG reports consulting or advisory roles with BMS, Ipsen, Merck Sharp & Dohme, AstraZeneca, Janssen-Cilag, Pfizer, Roche, Merck Serono, and Astellas Pharma; and honoraria from Merck Serono and AstraZeneca.

CKK reports consulting or advisory roles with Pfizer, BMS, Astellas Pharma, Ipsen, Eisai, Janssen, Merck KGaA, Merck, Gilead Sciences, Bayer, and AAA/Endocyte/Novartis; travel, accommodations, expenses from Pfizer, Ipsen, and Janssen Oncology; and honoraria from Pfizer, BMS, Ipsen, Merck KGaA, Merck, Astellas Pharma, Janssen Oncology, Eisai, and Bayer.

M-OG reports consulting or advisory roles with AstraZeneca, BMS, Ipsen, MSD, Pfizer, EUSA Pharma, Merck Serono, Takeda, Eisai, Bayer Vital, Janssen-Cilag, Gilead Sciences, and Novartis; research funding to institution from BMS, Intuitive Surgical, and Bayer Vital; travel, accommodations, expenses from BMS, Merck Serono, MSD, Janssen-Cilag, Ipsen, and AstraZeneca; and honoraria from AstraZeneca, BMS, MSD, Pfizer, Ipsen, Merck Serono, EUSA Pharma, and Janssen-Cilag.

CB reports grants/research support to institution from Nektar, Pfizer, Polyphor, Amgen, Daiichi Sankyo, Sanofi, Exelixis, Regeneron, Novartis, GSK, Janssen, OBI Pharma, Lilly, Seagen, Roche, BMS, MSD, Astra Zeneca, Novocure, AVEO Oncology, Takeda, PharmaMar, Gilead Sciences, Servier, Tolmar, Nanobiotix, and Dizal Pharma; and ownership or stocks holdings with Tummi and MEDSir; advisory boards and consulting roles with Gilead, Boehringer-Ingelheim, GSK, Novartis, Pfizer, Roche/Genentech, Eisai, Bayer, MSD, Astra Zeneca, Zodiac, Lilly, Sanofi, Daiichi, and Roche.

YT reports consulting or advisory roles with Eisai, MSD, Ono Pharmaceutical, and Taiho Pharmaceuticals; honoraria from Astellas Pharma, BMS Japan, Chugai Pharma, Ono Pharmaceutical, Takeda, Merck, Pfizer, and MSD; and research funding to institution from Astellas Pharma, AstraZeneca, Chugai Pharma, Eisai, MSD, Ono Pharmaceutical, Pfizer, and Takeda.

DC reports consulting or advisory roles with Pfizer, Roche, BMS, Janssen, Astellas, MSD, Ipsen, AstraZeneca, Novartis, and GSK; honoraria from Pfizer, Roche, MSD, BMS, AstraZeneca, Janssen, Astellas, Ipsen, Exelixis, Eisai, Lilly, Bayer, GSK, Clovis, and QED Therapeutics; and non-financial interest as Executive Member of the Spanish Oncology Genito-Urinary Group.

VG reports consulting or advisory roles with BMS, Pfizer, Novartis, MSD Oncology, Ipsen, Janssen-Cilag, Onkowissen, Cor2ED, Eisai, Debiopharm Group, PCI Biotech, Gilead Sciences, Cureteq, and Oncorena; travel, accommodations, expenses from Pfizer, AstraZeneca, Janssen, and Merck Serono; stock ownership with MSD, BMS, AstraZeneca, Seagen, and Genmab; honoraria from BMS, Pfizer, Ipsen, Eisai, MSD Oncology, Merck Serono, AstraZeneca, EUSA Pharma, Janssen-Cilag, Advanced Accelerator Applications/Novartis, Apogepha, Nanobiotix, Ono Pharmaceutical, and Astellas Pharma; and research funding to institution from Amgen, MSD Oncology, BMS, Seagen, Ipsen, and Gilead Sciences.

BIR reports consulting or advisory roles with Pfizer, Merck, BMS, AVEO, Surface Oncology, Corvus Pharmaceuticals, Aravive, Arrowhead Pharmaceuticals, Eisai, Genentech, Alkermes, NiKang Therapeutics, EUSA Pharma, Athenex, Debiopharm Group, HiberCell, MJH Life Sciences, and MashupMD; travel, accommodations, expenses from Pfizer, BMS, and Merck; stock ownership with PTC Therapeutics; and research funding to institution from Pfizer, Roche/Genentech, BMS, Merck, AstraZeneca/ MedImmune, Incyte, Arrowhead Pharmaceuticals, Seagen, Surface Oncology, Dragonfly Therapeutics, Aravive, Exelixis, AVEO, Arcus Biosciences, HiberCell, Stata, ADC Therapeutics, Dracen, Janssen, Adela, Pionyr, VasGene Therapeutics, Gilead Sciences, Point Therapeutics, and Daiichi Sankyo/UCB Japan.

RJ reports employment, leadership, travel, and stock ownership with BMS.

HD reports employment and stock ownership with BMS.

VF reports employment and stock ownership with BMS.

C-WL reports employment and stock ownership with BMS.

RJM reports consulting or advisory roles with Eisai, Exelixis, Merck, Genentech/Roche, Incyte, Pfizer, AstraZeneca, EMD Serono, Calithera Biosciences, AVEO, and Takeda; travel, accommodations, expenses from BMS; and research funding to institution from Pfizer, BMS, Eisai, Novartis, Genentech/Roche, Exelixis, Merck, and AVEO.

Figures

**Figure 1.. Kaplan-Meier estimates of overall survival (OS), progression-free survival (PFS), and duration of response (DOR) in the intent-to-treat (ITT) population**
NE, not estimable; NIVO+IPI, nivolumab plus ipilimumab; NR, not reached; SUN, sunitinib. Symbols represent censored observations. Stratified Cox proportional hazards model. HR is NIVO+IPI over SUN. Stratified by International Metastatic Renal Cell Carcinoma Database Consortium prognostic risk score (0, 1-2, 3-6) and region (USA, Canada/W Europe/N Europe, rest of world) as entered into the interactive voice-response system. Response was assessed response per independent radiology review committee (IRRC) using Response Evaluation Criteria in Solid Tumors v1.1. Two-sided 95% CI for median DOR computed by Brookmeyer and Crowley method (log-log transformation).

**Figure 2.. Kaplan-Meier estimates of overall survival (OS), progression-free survival (PFS), and duration of response (DOR) in patients with intermediate/poor risk**
NE, not estimable; NIVO+IPI, nivolumab plus ipilimumab; SUN, sunitinib. Symbols represent censored observations. Stratified Cox proportional hazards model. HR is NIVO+IPI over SUN. Stratified by International Metastatic Renal Cell Carcinoma Database Consortium prognostic risk score (0, 1-2, 3-6) and region (USA, Canada/W Europe/N Europe, rest of world) as entered into the interactive voice-response system. Response was assessed by an independent radiology review committee according to Response Evaluation Criteria in Solid Tumors v1.1. Two-sided 95% CI for median DOR computed by Brookmeyer and Crowley method (log-log transformation).

**Figure 3.. Kaplan-Meier estimates of overall survival (OS), progression-free survival (PFS), and duration of response (DOR) in patients with favorable risk**
NE, not estimable; NIVO+IPI, nivolumab plus ipilimumab; SUN, sunitinib. Symbols represent censored observations. Stratified Cox proportional hazards model. HR is NIVO+IPI over SUN. Stratified by International Metastatic Renal Cell Carcinoma Database Consortium prognostic risk score (0, 1-2, 3-6) and region (USA, Canada/W Europe/N Europe, rest of world) as entered into the interactive voice-response system. Response was assessed by an independent radiology review committee according to Response Evaluation Criteria in Solid Tumors v1.1. Two-sided 95% CI for median DOR computed by Brookmeyer and Crowley method (log-log transformation).

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Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 8-year follow-up results of efficacy and safety from the phase III CheckMate 214 trial

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Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 8-year follow-up results of efficacy and safety from the phase III CheckMate 214 trial

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