Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma.
Publication/Presentation Date
3-4-2021
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
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.).
Volume
384
Issue
9
First Page
829
Last Page
841
ISSN
1533-4406
Published In/Presented At
Choueiri, T. K., Powles, T., Burotto, M., Escudier, B., Bourlon, M. T., Zurawski, B., Oyervides Juárez, V. M., Hsieh, J. J., Basso, U., Shah, A. Y., Suárez, C., Hamzaj, A., Goh, J. C., Barrios, C., Richardet, M., Porta, C., Kowalyszyn, R., Feregrino, J. P., Żołnierek, J., Pook, D., … CheckMate 9ER Investigators (2021). Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma. The New England journal of medicine, 384(9), 829–841. https://doi.org/10.1056/NEJMoa2026982
Disciplines
Medicine and Health Sciences
PubMedID
33657295
Department(s)
Hematology-Medical Oncology Division, Lehigh Valley Topper Cancer Institute
Document Type
Article