NEJM 4Mar2021 Article " Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcino | BMY Message Board Posts

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Msg  6385 of 6713  at  3/3/2021 6:40:46 PM  by

JBWIN

The following message was updated on 3/4/2021 9:56:06 AM.

NEJM 4Mar2021 Article " Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma" (Checkmate-9ER)

 
  

Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma

List of authors.
  • Toni K. Choueiri, M.D.,
  • Thomas Powles, M.D.,
  • Mauricio Burotto, M.D.,
  • Bernard Escudier, M.D.,
  • Maria T. Bourlon, M.D.,
  • Bogdan Zurawski, M.D., Ph.D.,
  • Victor M. Oyervides Juárez, M.D.,
  • James J. Hsieh, M.D., Ph.D.,
  • Umberto Basso, M.D.,
  • Amishi Y. Shah, M.D.,
  • Cristina Suárez, M.D., Ph.D.,
  • Alketa Hamzaj, M.D.,
  • for the CheckMate 9ER Investigators*
 
 
March 4, 2021
N Engl J Med 2021; 384:829-841
DOI: 10.1056/NEJMoa2026982
 

Abstract

 
 

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. opens in new tab.)

 
 
 
 
 
 
 
 
 
 


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