期刊
NEW ENGLAND JOURNAL OF MEDICINE
卷 384, 期 9, 页码 829-841出版社
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa2026982
关键词
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资金
- Bristol Myers Squibb
- Ono Pharmaceutical
- Exelixis
- Ipsen Pharma
- Takeda Pharmaceutical
- Dana-Farber/Harvard Cancer Center Kidney Specialized Program of Research Excellence
- Kohlberg Chair at Harvard Medical School
- Loker Pinard Funds for Kidney Cancer Research at Dana-Farber Cancer Institute
- National Cancer Institute, Department of Defense
- Cancer Center Support Grant-Core Grant [P30 CA008748]
- National Institutes of Health Core Grant [P30 CA016672]
- Trust Family
The study demonstrates that nivolumab plus cabozantinib has significant advantages over sunitinib in the treatment of previously untreated advanced renal-cell carcinoma, including progression-free survival, overall survival, and likelihood of response.
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.)
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