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Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial
RJ. Motzer, B. Escudier, DF. McDermott, O. Arén Frontera, B. Melichar, T. Powles, F. Donskov, ER. Plimack, P. Barthélémy, HJ. Hammers, S. George, V. Grünwald, C. Porta, V. Neiman, A. Ravaud, TK. Choueiri, BI. Rini, P. Salman, CK. Kollmannsberger,...
Language English Country Great Britain
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
Grant support
P30 CA008748
NCI NIH HHS - United States
P30 CA016672
NCI NIH HHS - United States
NLK
BioMedCentral Open Access
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Directory of Open Access Journals
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Free Medical Journals
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PubMed Central
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Europe PubMed Central
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from 2013-05-01
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Open Access Digital Library
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Health & Medicine (ProQuest)
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- MeSH
- Survival Analysis MeSH
- Ipilimumab pharmacology therapeutic use MeSH
- Carcinoma, Renal Cell drug therapy mortality pathology MeSH
- Humans MeSH
- Kidney Neoplasms drug therapy mortality pathology MeSH
- Follow-Up Studies MeSH
- Nivolumab pharmacology therapeutic use MeSH
- Antineoplastic Combined Chemotherapy Protocols pharmacology therapeutic use MeSH
- Sunitinib pharmacology therapeutic use MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Research Support, N.I.H., Extramural MeSH
BACKGROUND: The extent to which response and survival benefits with immunotherapy-based regimens persist informs optimal first-line treatment options. We provide long-term follow-up in patients with advanced renal cell carcinoma (aRCC) receiving first-line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib (SUN) in the phase 3 CheckMate 214 trial. Survival, response, and safety outcomes with NIVO+IPI versus SUN were assessed after a minimum of 42 months of follow-up. METHODS: Patients with aRCC were enrolled from October 16, 2014, through February 23, 2016. Patients stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and region were randomized to nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for four doses, followed by nivolumab (3 mg/kg) every 2 weeks; or SUN (50 mg) once per day for 4 weeks (6-week cycle). Primary endpoints: overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) per independent radiology review committee in IMDC intermediate-risk/poor-risk patients. Secondary endpoints: OS, PFS, and ORR in the intention-to-treat (ITT) population and safety. Favorable-risk patient outcomes were exploratory. RESULTS: Among ITT patients, 550 were randomized to NIVO+IPI (425 intermediate/poor risk; 125 favorable risk) and 546 to SUN (422 intermediate/poor risk; 124 favorable risk). Among intermediate-risk/poor-risk patients, OS (HR, 0.66; 95% CI, 0.55-0.80) and PFS (HR, 0.75; 95% CI, 0.62-0.90) benefits were observed, and ORR was higher (42.1% vs 26.3%) with NIVO+IPI versus SUN. In ITT patients, both OS benefits (HR, 0.72; 95% CI, 0.61-0.86) and higher ORR (39.1% vs 32.6%) were observed with NIVO+IPI versus SUN. In favorable-risk patients, HR for death was 1.19 (95% CI, 0.77-1.85) and ORR was 28.8% with NIVO+IPI versus 54.0% with SUN. Duration of response was longer (HR, 0.46-0.54), and more patients achieved complete response (10.1%-12.8% vs 1.4%-5.6%) with NIVO+IPI versus SUN regardless of risk group. The incidence of treatment-related adverse events was consistent with previous reports. CONCLUSIONS: NIVO+IPI led to improved efficacy outcomes versus SUN in both intermediate-risk/poor-risk and ITT patients that were maintained through 42 months' minimum follow-up. A complete response rate >10% was achieved with NIVO+IPI regardless of risk category, with no new safety signals detected in either arm. These results support NIVO+IPI as a first-line treatment option with the potential for durable response. TRIAL REGISTRATION NUMBER: NCT02231749.
Bristol Myers Squibb Princeton New Jersey USA
Centro de Investigación Clínica Bradford Hill Santiago Chile
Clinic for Medical Oncology and Clinic for Urology Essen University Hospital Essen Germany
Clinical Research Division Fred Hutchinson Cancer Research Center Seattle Washington USA
Davidoff Cancer Center Rabin Medical Center Petah Tikva Israel
Department of Hematology and Oncology Cleveland Clinic Taussig Cancer Institute Cleveland Ohio USA
Department of Hematology Oncology Fox Chase Cancer Center Philadelphia Pennsylvania USA
Department of Internal Medicine University of Pavia Pavia Italy
Department of Medical Oncology Bordeaux University Hospital Bordeaux France
Department of Medical Oncology Gustave Roussy Villejuif France
Department of Medical Oncology Hôpitaux Universitaires de Strasbourg ICANS Strasbourg France
Department of Medical Oncology Levine Cancer Institute Atrium Health Charlotte North Carolina USA
Department of Medical Oncology Westmead Hospital Sydney New South Wales Australia
Department of Medicine Division of Medical Oncology University of Washington Seattle Washington USA
Department of Medicine Memorial Sloan Kettering Cancer Center New York New York USA
Department of Oncology Aarhus University Hospital Aarhus Denmark
Department of Oncology Herlev Hospital Copenhagen Denmark
Department of Oncology Palacky University and University Hospital Olomouc Olomouc Czech Republic
Department of Urology Jena University Hospital Jena Germany
Division of Hematology and Oncology UT Southwestern Kidney Cancer Program Dallas Texas USA
Division of Medical Oncology British Columbia Cancer Agency Vancouver British Columbia Canada
Instituto Oncológico Fundación Arturo López Pérez Santiago Chile
Interdisciplinary Genitourinary Oncology West German Cancer Center Essen Essen Germany
Oncology Institute Shamir Medical Center Be'er Yaakov Israel
Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel
References provided by Crossref.org
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- $a Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial / $c RJ. Motzer, B. Escudier, DF. McDermott, O. Arén Frontera, B. Melichar, T. Powles, F. Donskov, ER. Plimack, P. Barthélémy, HJ. Hammers, S. George, V. Grünwald, C. Porta, V. Neiman, A. Ravaud, TK. Choueiri, BI. Rini, P. Salman, CK. Kollmannsberger, SS. Tykodi, MO. Grimm, H. Gurney, R. Leibowitz-Amit, PF. Geertsen, A. Amin, Y. Tomita, MB. McHenry, SS. Saggi, NM. Tannir
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- $a BACKGROUND: The extent to which response and survival benefits with immunotherapy-based regimens persist informs optimal first-line treatment options. We provide long-term follow-up in patients with advanced renal cell carcinoma (aRCC) receiving first-line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib (SUN) in the phase 3 CheckMate 214 trial. Survival, response, and safety outcomes with NIVO+IPI versus SUN were assessed after a minimum of 42 months of follow-up. METHODS: Patients with aRCC were enrolled from October 16, 2014, through February 23, 2016. Patients stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and region were randomized to nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for four doses, followed by nivolumab (3 mg/kg) every 2 weeks; or SUN (50 mg) once per day for 4 weeks (6-week cycle). Primary endpoints: overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) per independent radiology review committee in IMDC intermediate-risk/poor-risk patients. Secondary endpoints: OS, PFS, and ORR in the intention-to-treat (ITT) population and safety. Favorable-risk patient outcomes were exploratory. RESULTS: Among ITT patients, 550 were randomized to NIVO+IPI (425 intermediate/poor risk; 125 favorable risk) and 546 to SUN (422 intermediate/poor risk; 124 favorable risk). Among intermediate-risk/poor-risk patients, OS (HR, 0.66; 95% CI, 0.55-0.80) and PFS (HR, 0.75; 95% CI, 0.62-0.90) benefits were observed, and ORR was higher (42.1% vs 26.3%) with NIVO+IPI versus SUN. In ITT patients, both OS benefits (HR, 0.72; 95% CI, 0.61-0.86) and higher ORR (39.1% vs 32.6%) were observed with NIVO+IPI versus SUN. In favorable-risk patients, HR for death was 1.19 (95% CI, 0.77-1.85) and ORR was 28.8% with NIVO+IPI versus 54.0% with SUN. Duration of response was longer (HR, 0.46-0.54), and more patients achieved complete response (10.1%-12.8% vs 1.4%-5.6%) with NIVO+IPI versus SUN regardless of risk group. The incidence of treatment-related adverse events was consistent with previous reports. CONCLUSIONS: NIVO+IPI led to improved efficacy outcomes versus SUN in both intermediate-risk/poor-risk and ITT patients that were maintained through 42 months' minimum follow-up. A complete response rate >10% was achieved with NIVO+IPI regardless of risk category, with no new safety signals detected in either arm. These results support NIVO+IPI as a first-line treatment option with the potential for durable response. TRIAL REGISTRATION NUMBER: NCT02231749.
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