Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial

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DOI

  • Robert J. Motzer, Memorial Sloan-Kettering Cancer Center
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  • Bernard Escudier, Institut Gustave Roussy
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  • Saby George, Roswell Park Cancer Institute
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  • Hans J. Hammers, University of Texas Southwestern Medical Center
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  • Sandhya Srinivas, Stanford University
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  • Scott S. Tykodi, Fred Hutchinson Cancer Research Center
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  • Jeffrey A. Sosman, Northwestern University
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  • Elizabeth R. Plimack, Fox Chase Cancer Center
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  • Giuseppe Procopio, IRCCS Fondazione Istituto Nazionale per lo studio e la cura dei tumori - Milano
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  • David F. McDermott, Dana-Farber/Harvard Cancer Center
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  • Daniel Castellano, Complutense University
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  • Toni K. Choueiri, Dana-Farber Cancer Institute
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  • Frede Donskov
  • Howard Gurney, Westmead Hospital
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  • Stéphane Oudard, Hopital Europeen Georges-Pompidou
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  • Martin Richardet, Fundacion Richardet Longo
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  • Katriina Peltola, University of Helsinki
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  • Ajjai S. Alva, University of Michigan, Ann Arbor
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  • Michael Carducci, Johns Hopkins University
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  • John Wagstaff, South West Wales Cancer Institute and Swansea University College of Medicine
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  • Christine Chevreau, Institut Claudius Regaud
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  • Satoshi Fukasawa, Chiba Cancer Center Hospital
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  • Yoshihiko Tomita, Niigata University Graduate School of Medical and Dental Sciences
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  • Thomas C. Gauler, University of Duisburg-Essen
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  • Christian K. Kollmannsberger, BC Cancer
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  • Fabio A. Schutz, Beneficencia Portuguesa de São Paulo
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  • James Larkin, Royal Marsden NHS Foundation Trust
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  • David Cella, Northwestern University
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  • M. Brent McHenry, Bristol-Myers Squibb
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  • Shruti Shally Saggi, Bristol-Myers Squibb
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  • Nizar M. Tannir, University of Texas MD Anderson Cancer Center

Background: CheckMate 025 has shown superior efficacy for nivolumab over everolimus in patients with advanced renal cell carcinoma (aRCC) along with improved safety and tolerability. This analysis assesses the long-term clinical benefits of nivolumab versus everolimus. Methods: The randomized, open-label, phase 3 CheckMate 025 trial (NCT01668784) included patients with clear cell aRCC previously treated with 1 or 2 antiangiogenic regimens. Patients were randomized to nivolumab (3 mg/kg every 2 weeks) or everolimus (10 mg once a day) until progression or unacceptable toxicity. The primary endpoint was overall survival (OS). The secondary endpoints were the confirmed objective response rate (ORR), progression-free survival (PFS), safety, and health-related quality of life (HRQOL). Results: Eight hundred twenty-one patients were randomized to nivolumab (n = 410) or everolimus (n = 411); 803 patients were treated (406 with nivolumab and 397 with everolimus). With a minimum follow-up of 64 months (median, 72 months), nivolumab maintained an OS benefit in comparison with everolimus (median, 25.8 months [95% CI, 22.2-29.8 months] vs 19.7 months [95% CI, 17.6-22.1 months]; hazard ratio [HR], 0.73; 95% CI, 0.62-0.85) with 5-year OS probabilities of 26% and 18%, respectively. ORR was higher with nivolumab (94 of 410 [23%] vs 17 of 411 [4%]; P <.001). PFS also favored nivolumab (HR, 0.84; 95% CI, 0.72-0.99; P =.0331). The most common treatment-related adverse events of any grade were fatigue (34.7%) and pruritus (15.5%) with nivolumab and fatigue (34.5%) and stomatitis (29.5%) with everolimus. HRQOL improved from baseline with nivolumab but remained the same or deteriorated with everolimus. Conclusions: The superior efficacy of nivolumab over everolimus is maintained after extended follow-up with no new safety signals, and this supports the long-term benefits of nivolumab monotherapy in patients with previously treated aRCC. LAY SUMMARY: CheckMate 025 compared the effects of nivolumab (a novel immunotherapy) with those of everolimus (an older standard-of-care therapy) for the treatment of advanced kidney cancer in patients who had progressed on antiangiogenic therapy. After 5 years of study, nivolumab continues to be better than everolimus in extending the lives of patients, providing a long-lasting response to treatment, and improving quality of life with a manageable safety profile. The results demonstrate that the clinical benefits of nivolumab versus everolimus in previously treated patients with advanced kidney cancer continue in the long term.

OriginalsprogEngelsk
TidsskriftCancer
Vol/bind126
Nummer18
Sider (fra-til)4156-4167
Antal sider12
ISSN0008-543X
DOI
StatusUdgivet - 2020

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