CheckMate 025 Randomized Phase 3 Study : Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma

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Escudier , B , Sharma , P , McDermott , D F , George , S , Hammers , H J , Srinivas , S , Tykodi , S S , Sosman , J A , Procopio , G , Plimack , E R , Castellano , D , Gurney , H , Donskov , F , Peltola , K , Wagstaff , J , Gauler , T C , Ueda , T , Zhao , H , Waxman , I M , Motzer , R J & CheckMate 025 Investigators 2017 , ' CheckMate 025 Randomized Phase 3 Study : Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma ' , European Urology , vol. 72 , no. 6 , pp. 962-971 . https://doi.org/10.1016/j.eururo.2017.02.010

Title: CheckMate 025 Randomized Phase 3 Study : Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma
Author: Escudier, Bernard; Sharma, Padmanee; McDermott, David F.; George, Saby; Hammers, Hans J.; Srinivas, Sandhya; Tykodi, Scott S.; Sosman, Jeffrey A.; Procopio, Giuseppe; Plimack, Elizabeth R.; Castellano, Daniel; Gurney, Howard; Donskov, Frede; Peltola, Katriina; Wagstaff, John; Gauler, Thomas C.; Ueda, Takeshi; Zhao, Huanyu; Waxman, Ian M.; Motzer, Robert J.; CheckMate 025 Investigators
Contributor: University of Helsinki, Department of Oncology
Date: 2017-12
Language: eng
Number of pages: 10
Belongs to series: European Urology
ISSN: 0302-2838
URI: http://hdl.handle.net/10138/298130
Abstract: Background: The randomized, phase 3 CheckMate 025 study of nivolumab (n = 410) versus everolimus (n = 411) in previously treated adults (75% male; 88% white) with advanced renal cell carcinoma (aRCC) demonstrated significantly improved overall survival (OS) and objective response rate (ORR). Objective: To investigate which baseline factors were associated with OS and ORR benefit with nivolumab versus everolimus. Design, setting, and participants: Subgroup OS analyses were performed using Kaplan-Meier methodology. Hazard ratios were estimated using the Cox proportional hazards model. Intervention: Nivolumab 3 mg/kg every 2 wk or everolimus 10 mg once daily. Results and limitations: The minimum follow-up was 14 mo. Baseline subgroup distributions were balanced between nivolumab and everolimus arms. Nivolumab demonstrated an OS improvement versus everolimus across subgroups, including Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium risk groups; age <65 and >= 65 yr; one and two or more sites of metastases; bone, liver, and lung metastases; number of prior therapies; duration of prior therapy; and prior sunitinib, pazopanib, or interleukin-2 therapy. The benefit with nivolumab versus everolimus was noteworthy for patients with poor MSKCC risk (hazard ratio 0.48, 95% confidence interval 0.32-0.70). The mortality rate at 12 mo for all subgroups was lower with nivolumab compared with everolimus. ORR also favored nivolumab. The incidence of grade 3 or 4 treatment-related adverse events across subgroups was lower with nivolumab. Limitations include the post hoc analysis and differing sample sizes between groups. Conclusion: The trend for OS and ORR benefit with nivolumab for multiple subgroups, without notable safety concerns, may help to guide treatment decisions, and further supports nivolumab as the standard of care in previously treated patients with aRCC. (C) 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Subject: Everolimus
Immune checkpoint inhibitor
Nivolumab
Phase 3
Renal cell carcinoma
TARGETED THERAPY
PD-1 BLOCKADE
CANCER
SURVIVAL
GUIDELINES
TUMORS
BONE
3122 Cancers
3126 Surgery, anesthesiology, intensive care, radiology
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