Study
Open-label, randomised, phase 3 trial (CheckMate 9ER) |
Previously untreated advanced or metastatic clear-cell renal cell carcinoma |
Nivolumab 240 mg/2 weeks plus cabozantinib 40 mg/day (N:323) or sunitinib 50 mg/day, 4 weeks per 6-week cycle (N:328) |
Efficacy
mOS:37·7 m vs 34·3 m (HR:0·70 [95% CI 0·55–0·90], p=0·0043) |
mPFS:16·6 m vs 8·3 m (HR 0·56 [95% CI 0·46−0·68], p<0·0001) |
Safety
Grade >= 3 AEs: 65% vs 54% |
Grade >=3 AEs: HT 13% vs 12%, palmar–plantar erythrodysaesthesia 8% vs 8%, diarrhoea 7% vs 5% |
Treatment-related serious AEs 22% vs 10% |
One treatment-related death occurred with sunitinib |
Lancet Oncol. 2022 Jul;23(7):888-898.
http://doi.org/10.1016/S1470-2045(22)00290-X
Reviewed by Hasan Cagri Yildirim, MD on Sep 20, 2022