Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma

CheckMate 9ER Investigators

Resultado de la investigación: Contribución a una revistaArtículorevisión exhaustiva

441 Citas (Scopus)

Resumen

BACKGROUND The efficacy and safety of nivolumab plus cabozantinib as compared with those of sunitinib in the treatment of previously untreated advanced renal-cell carcinoma are not known. METHODS In this phase 3, randomized, open-label trial, we randomly assigned adults with previously untreated clear-cell, advanced renal-cell carcinoma to receive either nivolumab (240 mg every 2 weeks) plus cabozantinib (40 mg once daily) or sunitinib (50 mg once daily for 4 weeks of each 6-week cycle). The primary end point was progression-free survival, as determined by blinded independent central review. Secondary end points included overall survival, objective response as determined by independent review, and safety. Health-related quality of life was an exploratory end point. RESULTS Overall, 651 patients were assigned to receive nivolumab plus cabozantinib (323 patients) or sunitinib (328 patients). At a median follow-up of 18.1 months for overall survival, the median progression-free survival was 16.6 months (95% confidence interval [CI], 12.5 to 24.9) with nivolumab plus cabozantinib and 8.3 months (95% CI, 7.0 to 9.7) with sunitinib (hazard ratio for disease progression or death, 0.51; 95% CI, 0.41 to 0.64; P<0.001). The probability of overall survival at 12 months was 85.7% (95% CI, 81.3 to 89.1) with nivolumab plus cabozantinib and 75.6% (95% CI, 70.5 to 80.0) with sunitinib (hazard ratio for death, 0.60; 98.89% CI, 0.40 to 0.89; P = 0.001). An objective response occurred in 55.7% of the patients receiving nivolumab plus cabozantinib and in 27.1% of those receiving sunitinib (P<0.001). Efficacy benefits with nivolumab plus cabozantinib were consistent across subgroups. Adverse events of any cause of grade 3 or higher occurred in 75.3% of the 320 patients receiving nivolumab plus cabozantinib and in 70.6% of the 320 patients receiving sunitinib. Overall, 19.7% of the patients in the combination group discontinued at least one of the trial drugs owing to adverse events, and 5.6% discontinued both. Patients reported better health-related quality of life with nivolumab plus cabozantinib than with sunitinib. CONCLUSIONS Nivolumab plus cabozantinib had significant benefits over sunitinib with respect to progression-free survival, overall survival, and likelihood of response in patients with previously untreated advanced renal-cell carcinoma. (Funded by Bristol Myers Squibb and others; CheckMate 9ER ClinicalTrials.gov number, NCT03141177.).
Idioma originalInglés
Páginas (desde-hasta)829-841
Número de páginas13
PublicaciónNew England Journal of Medicine
Volumen384
N.º9
DOI
EstadoPublicada - 4 mar. 2021
Publicado de forma externa

Nota bibliográfica

Publisher Copyright:
Copyright © 2021 Massachusetts Medical Society.

Palabras clave

  • Adult
  • Aged
  • 80 and over
  • Anilides
  • Antineoplastic Agents
  • Antineoplastic Combined Chemotherapy Protocols
  • B7-H1 Antigen
  • Carcinoma
  • Renal Cell
  • Female; Humans
  • Intention to Treat Analysis
  • Kidney Neoplasms
  • Male
  • Middle Aged
  • Nivolumab
  • Progression-Free Survival
  • Proportional Hazards Models
  • Pyridines
  • Quality of Life
  • Receptor Protein-Tyrosine Kinases
  • Sunitinib
  • Survival Analysis

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