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Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma.

Publication ,  Journal Article
Tannir, NM; Signoretti, S; Choueiri, TK; McDermott, DF; Motzer, RJ; Flaifel, A; Pignon, J-C; Ficial, M; Frontera, OA; George, S; Powles, T ...
Published in: Clinical cancer research : an official journal of the American Association for Cancer Research
January 2021

Patients with advanced renal cell carcinoma with sarcomatoid features (sRCC) have poor prognoses and suboptimal outcomes with targeted therapy. This post hoc analysis of the phase III CheckMate 214 trial analyzed the efficacy of nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib in patients with sRCC.Patients with sRCC were identified via independent central pathology review of archival tumor tissue or histologic classification per local pathology report. Patients were randomized 1:1 to receive nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks (four doses) then nivolumab 3 mg/kg every 2 weeks, or sunitinib 50 mg orally every day (4 weeks; 6-week cycles). Outcomes in patients with sRCC were not prespecified. Endpoints in patients with sRCC and International Metastatic Renal Cell Carcinoma Database Consortium intermediate/poor-risk disease included overall survival (OS), progression-free survival (PFS) per independent radiology review, and objective response rate (ORR) per RECIST v1.1. Safety outcomes used descriptive statistics.Of 1,096 randomized patients in CheckMate 214, 139 patients with sRCC and intermediate/poor-risk disease and six with favorable-risk disease were identified. With 42 months' minimum follow-up in patients with sRCC and intermediate/poor-risk disease, median OS [95% confidence interval (CI)] favored NIVO+IPI [not reached (NR) (25.2-not estimable [NE]); n = 74] versus sunitinib [14.2 months (9.3-22.9); n = 65; HR, 0.45 (95% CI, 0.3-0.7; P = 0.0004)]; PFS benefits with NIVO+IPI were similarly observed [median 26.5 vs. 5.1 months; HR, 0.54 (95% CI, 0.33-0.86; P = 0.0093)]. Confirmed ORR was 60.8% with NIVO+IPI versus 23.1% with sunitinib, with complete response rates of 18.9% versus 3.1%, respectively. No new safety signals emerged.NIVO+IPI showed unprecedented long-term survival, response, and complete response benefits versus sunitinib in previously untreated patients with sRCC and intermediate/poor-risk disease, supporting the use of first-line NIVO+IPI for this population.See related commentary by Hwang et al., p. 5.

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Published In

Clinical cancer research : an official journal of the American Association for Cancer Research

DOI

EISSN

1557-3265

ISSN

1078-0432

Publication Date

January 2021

Volume

27

Issue

1

Start / End Page

78 / 86

Related Subject Headings

  • Sunitinib
  • Protein Serine-Threonine Kinases
  • Oncology & Carcinogenesis
  • Nivolumab
  • Kidney Neoplasms
  • Ipilimumab
  • Immunotherapy
  • Humans
  • Hippo Signaling Pathway
  • Carcinoma, Renal Cell
 

Citation

APA
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Tannir, N. M., Signoretti, S., Choueiri, T. K., McDermott, D. F., Motzer, R. J., Flaifel, A., … Rini, B. I. (2021). Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma. Clinical Cancer Research : An Official Journal of the American Association for Cancer Research, 27(1), 78–86. https://doi.org/10.1158/1078-0432.ccr-20-2063
Tannir, Nizar M., Sabina Signoretti, Toni K. Choueiri, David F. McDermott, Robert J. Motzer, Abdallah Flaifel, Jean-Christophe Pignon, et al. “Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma.Clinical Cancer Research : An Official Journal of the American Association for Cancer Research 27, no. 1 (January 2021): 78–86. https://doi.org/10.1158/1078-0432.ccr-20-2063.
Tannir NM, Signoretti S, Choueiri TK, McDermott DF, Motzer RJ, Flaifel A, et al. Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research. 2021 Jan;27(1):78–86.
Tannir, Nizar M., et al. “Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma.Clinical Cancer Research : An Official Journal of the American Association for Cancer Research, vol. 27, no. 1, Jan. 2021, pp. 78–86. Epmc, doi:10.1158/1078-0432.ccr-20-2063.
Tannir NM, Signoretti S, Choueiri TK, McDermott DF, Motzer RJ, Flaifel A, Pignon J-C, Ficial M, Frontera OA, George S, Powles T, Donskov F, Harrison MR, Barthélémy P, Tykodi SS, Kocsis J, Ravaud A, Rodriguez-Cid JR, Pal SK, Murad AM, Ishii Y, Saggi SS, McHenry MB, Rini BI. Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma. Clinical cancer research : an official journal of the American Association for Cancer Research. 2021 Jan;27(1):78–86.

Published In

Clinical cancer research : an official journal of the American Association for Cancer Research

DOI

EISSN

1557-3265

ISSN

1078-0432

Publication Date

January 2021

Volume

27

Issue

1

Start / End Page

78 / 86

Related Subject Headings

  • Sunitinib
  • Protein Serine-Threonine Kinases
  • Oncology & Carcinogenesis
  • Nivolumab
  • Kidney Neoplasms
  • Ipilimumab
  • Immunotherapy
  • Humans
  • Hippo Signaling Pathway
  • Carcinoma, Renal Cell