Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

3076 - Characterization of Response to Nivolumab Plus Ipilimumab (N+I) or Sunitinib (S) in Patients (Pts) With Previously Untreated Advanced Renal Cell Carcinoma (aRCC): CheckMate 215


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care


Tumour Site

Renal Cell Cancer


Brian Rini


Annals of Oncology (2018) 29 (suppl_8): viii303-viii331. 10.1093/annonc/mdy283


B.I. Rini1, N.M. Tannir2, B. Escudier3, D.F. McDermott4, M. Grimm5, C. Porta6, T. Powles7, C.K. Kollmannsberger8, H.P. Gurney9, S.S. Tykodi10, M. Harrison11, D.Y.C. Heng12, V. Grünwald13, T.K. Choueiri14, S. Mekan15, M..B. McHenry15, H.J. Hammers16, R.J. Motzer17, S. George18

Author affiliations

  • 1 Department Of Hematology And Oncology, Cleveland Clinic Taussig Cancer Institute, 44195 - Cleveland/US
  • 2 Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, 77030-3721 - Houston/US
  • 3 Department Of Medical Oncology, Gustave Roussy, 94805 - Villejuif/FR
  • 4 Department Of Medicine, Beth Israel Deaconess Med. Center, 2215 - Boston/US
  • 5 Department Of Urology, Jena University Hospital, 7740 - Jena/DE
  • 6 Department Of Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico San Matteo University Hospital Foundation, 27100 - Pavia/IT
  • 7 Department Of Medicine, Barts Cancer Institute, EC1M 6BQ - London/GB
  • 8 Department Of Medicine, British Columbia Cancer Agency, V5Z 4E6 - Vancouver/CA
  • 9 Department Of Medical Oncology, Westmead Hospital and Macquarie University, 2145 - Westmead/AU
  • 10 Department Of Medicine, Fred Hutchinson Cancer Research Center, 98109 - Seattle/US
  • 11 Department Of Medicine, Duke University Medical Center, 27710 - Durham/US
  • 12 Department Of Oncology, Tom Baker Cancer Center, T2N 4N2 - Calgary/CA
  • 13 Department Of Hematology And Oncology, Hannover Medical School, 30625 - Hannover/DE
  • 14 Department Of Genitourinary Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 15 Clinical Development, Bristol-Myers Squibb Company, NJ 08648 - Lawrenceville/US
  • 16 Department Of Hematology And Oncology, University of Texas Southwestern Medical Center at Dallas, 75390-8576 - Dallas/US
  • 17 Department Of Genitourinary Oncology, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 18 Department Of Medicine, Roswell Park Cancer Institute, 14263 - Buffalo/US


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 3076


N+I demonstrated superior objective response rate (ORR) and overall survival (OS) vs sunitinib in pts with IMDC intermediate/poor (int/poor)-risk aRCC in the phase 3 CheckMate 214 trial. Further characterization of response may inform clinical practice.


In CheckMate 214, pts with previously untreated aRCC were randomly assigned 1:1 to N 3 mg/kg + I 1 mg/kg Q3W for 4 doses then N 3 mg/kg Q2W or S 50 mg QD for 4 weeks on, 2 weeks off. Efficacy, safety, and quality of life (QoL) were explored in int/poor-risk pts with complete response (CR) or partial response to N+I or S.


At 25.2 months median follow-up, confirmed ORR per independent radiology review committee in int/poor-risk pts was 42% for N+I vs 27% for S (P < 0.001; Table) with 36% vs 18% of pts achieving best tumor reduction ≥50% with N+I vs S. Of N+I vs S responders, 72% vs 63% have ongoing response, 47% and 34% remain on treatment, and 53% and 66% discontinued, most often for disease progression (N+I, 22%; S, 40%) or toxicity (N+I, 23%; S, 13%). N+I responders received a median of 21.0 months of treatment (vs 3.8 months for N+I nonresponders). Response lasting ≥18 months was seen in 13% of N+I and 4% of S pts. Grade 3–4 treatment-related adverse events (TRAEs) occurred in 52% of N+I and 68% of S responders. Mean change from baseline at 24 weeks in Functional Assessment of Cancer Therapy–Kidney Symptom Index 19 score was 3.0 in N+I responders (better) vs − 0.7 in S responders (worse). Updated 3-year data on responders, including use of subsequent therapies, will be presented.Table: 875P

OutcomeN+I int/poor-risk ptsS int/poor-risk pts
Total n = 425CR n = 40PR n = 137Total n = 422CR n = 5PR n = 107
BOR (95% CI), %42 (37–47)93227 (22–31)125
Median (range) time to response, months2.8 (0.9–11.3)2.8 (0.9–11.0)2.8 (1.4–11.3)3.0 (0.6–15.0)2.9 (2.8–4.2)3.1 (0.6–15.0)
Median (95% CI) duration of response, monthsNR (21.8–NE)NRNR (18.8–NE)18.2 (14.8–NE)NR18.2 (13.9–NE)
Pts with ongoing response in responders, n/N (%)128/177 (72)34/40 (85)94/137 (69)71/112 (63)5/5 (100)66/107 (62)
12-month PFS rate (95% CI), %50 (44–55)97 (83–100)81 (73–86)43 (37–48)100 (100–100)79 (69–86)
18-month OS rate (95% CI), %78 (74–81)100 (100–100)94 (89–97)68 (63–72)100 (100–100)92 (85–96)

BOR, best overall response; NE, not estimable; NR, not reached; PR, partial response


ORR and OS were significantly improved with N+I compared with S in pts with int/poor-risk aRCC in CheckMate 214. Responses to N+I were more likely to be CRs and were more durable than responses to S. High-grade TRAEs were less frequent and QoL was better in N+I responders compared with S responders.

Clinical trial identification


Legal entity responsible for the study

Bristol-Myers Squibb.


Bristol-Myers Squibb and Ono Pharmaceutical Company Limited.

Editorial Acknowledgement

Professional medical writing assistance was provided by Nicolette Belletier, PhD, of PPSI, funded by Bristol-Myers Squibb.


B.I. Rini: Consulting or Advisory role: Bristol-Myers Squibb. N.M. Tannir: Research funding: Bristol-Myers Squibb, Epizyme, Exelixis, Mirati, Novartis; Consulting or Advisory role: Argos, Bristol-Myers Squibb, Eisai, Exelixis, Nektar, Novartis, Oncorena, Pfizer; Advisory board member: Eisai, Exelixis, Nektar, Novartis, Oncorena. B. Escudier: Honoraria: Bristol-Myers Squibb, Bayer, Novartis, Pfizer, Exelixis, Roche. D.F. McDermott: Consulting or Advisory role: Array BioPharma, Bristol-Myers Squibb, Eisai, Exelixis, Genentech, Merck, Novartis, Pfizer; Research funding: Prometheus (Inst). M-O. Grimm: Honoraria: Pfizer, MSD, Apogepha; Consulting or Advisory role: Roche; Research funding: Novartis, Bristol-Myers Squibb. C. Porta: Consulting or Advisory role: Bristol-Myers Squibb, Pfizer, Novartis, Ipsen, Eisai, EUSA, Janssen. T. Powles: Research funding: AstraZeneca, Novartis, Roche; Honoraria: AstraZeneca, Merck, Bristol-Myers Squibb, Pfizer, Roche. C.K. Kollmannsberger: Honoraria: Bristol-Myers Squibb, Pfizer; Consulting or Advisory role: Bristol-Myers Squibb, Pfizer. H.P. Gurney: Consulting or Advisory role: Astellas, Bristol-Myers Squibb, Novartis, Pfizer. S.S. Tykodi: Consulting or Advisory role: Bristol-Myers Squibb, Calithera Biosciences, Prometheus Laboratories; Research funding to institution: Bristol-Myers Squibb, Calithera Biosciences, Merck, Nektar Therapeutics, Peloton Therapeutics, Jounce Therapeutics, Pfizer, Genentech, Prometheus Laboratories, Argos Therapeutics. D.Y.C. Heng: Consulting or Advisory role: Bristol-Myers Squibb, Pfizer, Novartis. V. Grünwald: Honoraria: Bristol-Myers Squibb; Consulting or Advisory role: Bristol-Myers Squibb, Novartis, Pfizer, Bayer; Speakers' Bureaus: Bristol-Myers Squibb, Novartis, Pfizer. T.K. Choueiri: Consulting or Advisory role: Merck, Novartis, Peloton, Pfizer, Roche, Eisai, Tracon, Bayer, Cerulean, Foundation Medicine, Inc., GlaxoSmithKline, Prometheus, Corvus; Research Funding to institution: Merck, Novartis, Peloton, Pfizer, Roche, Eisai, Tracon. S. Mekan: Employment or Other ownership: Bristol-Myers Squibb. H.J. Hammers: Consulting or Advisory role: Bristol-Myers Squibb, Pfizer, Exelixis; Research Funding: Bristol-Myers Squibb; Travel, accommodations, Expenses: Bristol- Myers Squibb, Pfizer, Exelixis. R.J. Motzer: Consulting or Advisory role: Eisai, Exelixis, Genentech/Roche, Merck, Novartis, Pfizer; Research funding: Bristol-Myers Squibb, Eisai, Exelixis, Novartis, Pfizer. S. George: Consulting or Advisory role: Bristol-Myers Squibb, Novartis, Bayer, Pfizer, Exelixis, AstraZeneca, Janssen Oncology, Corvus Pharmaceuticals, Genentech/Roche; Research funding (inst): Pfizer, Acceleron Pharma, Merck, Agensys, Novartis, Bristol-Myers Squibb, Bayer. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.