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CheckMate 214: Efficacy and safety of nivolumab + ipilimumab (N+I) v sunitinib (S) for treatment-naïve advanced or metastatic renal cell carcinoma (mRCC), including IMDC risk and PD-L1 expression subgroups

Date

10 Sep 2017

Session

Presidential Symposium II

Presenters

Bernard Escudier

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

B. Escudier1, N. Tannir2, D.F. McDermott3, O.A. Frontera4, B. Melichar5, E.R. Plimack6, P. Barthelemy7, S. George8, V. Neiman9, C. Porta10, T.K. Choueiri11, T. Powles12, F. Donskov13, P. Salman14, C.K. Kollmannsberger15, B. Rini16, S. Mekan17, M..B. McHenry17, H.H. Hammers18, R.J. Motzer19

Author affiliations

  • 1 Department Of Medical Oncology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 2 Department Of Genitourinary Oncology, University of Texas, MD Anderson Cancer Center Hospital, 77030-3721 - Houston/US
  • 3 Oncology, Beth Israel Deaconess Medical Center, Boston/US
  • 4 Department Of Oncology, Centro Internacional de Estudios Clinicos, Santiago/CL
  • 5 Department Of Oncology, Palacky University Medical School and Teaching Hospital, Olomouc,, Olomouc/CZ
  • 6 Department Of Hematology/oncology, Fox Chase Cancer Center, 19111-2497 - Philadelphia/US
  • 7 Service D'hématologie Et D'oncologie, Hôpitaux Universitaires de Strasbourg, 67000 - Strasbourg/FR
  • 8 Department Of Medicine, Roswell Park Cancer Institute, NY - Buffalo/US
  • 9 Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tikva/IL
  • 10 Medical Oncology, I.R.C.C.S. San Matteo University Hospital Foundation, Pavia/IT
  • 11 Genitourinary Oncology, Dana-Farber Cancer Institute and Women's Hospital, 02215 - Boston/US
  • 12 Medical Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, London/GB
  • 13 Department Of Oncology, Aarhus University Hospital, 8000 - Aarhus C/DK
  • 14 Department Of Oncology, Fundacion Arturo Lopez Perez, 750-0921 - Santiago/CL
  • 15 Department Of Medicine, British Columbia Cancer Agency, V5Z 4E6 - Vancouver/CA
  • 16 Hematology And Medical Oncology, Cleveland Clinic, 44195 - Cleveland/US
  • 17 Publications, Bristol-Myers Squibb, 08540 - Princeton/US
  • 18 Department Of Hematology And Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore/US
  • 19 Medical Oncology, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
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Background

We report results from the phase 3 CheckMate 214 study of N+I v S for treatment-naïve mRCC.

Methods

Adults with measurable clear-cell mRCC, KPS ≥70, and available tumor tissue were randomized 1:1 (stratified by IMDC score; region) to N 3 mg/kg + I 1 mg/kg every 3 wk for 4 doses followed by N 3 mg/kg every 2 wk, or S 50 mg daily orally for 4 wk (6-wk cycles). Co-primary endpoints: ORR, PFS per independent committee (IRRC) and OS all in intermediate/poor risk pts. Overall α for treatment effect = 0.05 (0.001 ORR, 0.009 PFS, 0.04 OS). Efficacy was also evaluated by IMDC risk group and baseline tumor PD-L1 expression.

Results

1096 pts were randomized (N+I: n = 550; S: n = 546). With ∼17.5 mo minimum follow-up, confirmed ORR in intermediate/poor risk pts was 41.6% (9.4% complete response [CR]) v 26.5% (1.2% CR) for N+I v S (P

Conclusions

This phase 3 study showed higher ORR and longer PFS for N+I v S in intermediate/poor risk mRCC, particularly in pts with tumor PD-L1 expression ≥1%, with a manageable safety profile. These results support the use of N+I as a potential first-line treatment for these pts.

Clinical trial identification

NCT02231749

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb and Ono Pharmaceutical Co. Ltd

Disclosure

B. Escudier: Received honoraria from Bayer, Novartis, Pfizer, BMS, Exelixis, Roche. N.M. Tannir: Received honoraria from or done consulting for Bristol-Myers Squibb, Exelixis, Nektar, Novartis, Pfizer, Argos, and Calithera, and has received research funding from Bristol-Myers Squibb, Exelixis, Epizyme, Novartis, and Miranti.

D.F. McDermott: Consultant for Genentech, Bristol-Meyers Squibb, Merck. Research support from Prometheus Labs. O.A. Frontera: Reports personal fees from Advisory Board, outside the submitted work E.R. Plimack: Served as an advisor or consultant for: Acceleron Pharma; Bristol-Myers Squibb Company; Genentech, Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc; Roche Received grants for clinical research from: Acceleron Pharma; AstraZeneca Pharmaceuticals LP; Bristol-Myers Squibb Company; GlaxoSmithKline; Lilly; Merck & Co., Inc.; Pfizer Inc. S. George: Employment: Amgen; Research funding: BMS, Novartis, Pfizer, Bayer, Acceleron, Agensys; Consulting: BMS, Novartis, Bayer, Astellas, Pfizer, Xcenda, Onclive. C. Porta: Consultant for: GlaxoSmithKline; Bayer HealthCare Pharmaceuticals; Schering-Plough Corporation; Pfizer Inc.; Roche; Novartis Pharmaceuticals Corporation Speakers bureau for: GlaxoSmithKline; Bayer HealthCare Pharmaceuticals; Schering-Plough Corporation; Pfizer Inc.; Roche; Novartis Pharmaceuticals Corporation Received grants from: Bayer HealthCare Pharmaceuticals; Schering-Plough Corporation; Novartis Pharmaceuticals Corporation. T.K. Choueiri: Consultant for GlaxoSmithKline; Novartis Pharmaceuticals Corporation; AVEO Pharmaceuticals, Inc.; and Pfizer Inc. T. Powles: Honoraria- BMS, Roche AZ, MSD, Novartis. F. Donskov: Research funding: Novartis, GSK, Pfizer. C.K. Kollmannsberger: Honoraria: Pfizer, Novartis, BMS; Consulting: Pfizer, Novartis, BMS, Sanofi, Astellas, Lilly. B. Rini: Consulting: Pfizer, Novartis, Accelion; Research funding: Pfizer, Immatics, BMS, Peleton; Expenses: Pfizer. S. Mekan, M.B. McHenry: Employee of BMS and holds stock options with BMS H.J. Hammers: Consulting: BMS, Exelixis, Pfizer, Cerulean, Bayer; Research funding: SFJ, BMS, Exelixis, Newlink, Pfizer, GSK, Tracon. R.J. Motzer: Consulting: Pfizer, Novartis, Eisai Inc.; Research funding: Exelixis, BMS, Novartis, Pfizer, Genentech/Roche. All other authors have declared no conflicts of interest.

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