The CheckMate 9ER trial demonstrated that nivolumab plus cabozantinib significantly improved progression-free survival and overall survival compared to sunitinib in untreated advanced renal cell carcinoma. The combination achieved a higher overall response rate and was generally well-tolerated, reaffirming it as a standard of care in this setting.
Study
|
Randomized, open-label, phase III study [CheckMate 9ER] |
| Advanced renal cell carcinoma, previously untreated |
| Nivolumab+Cabozantinib (n=323) vs Sunitinib (n=328) first-line treatment
|
Efficacy
|
ORR: 55.7% vs 27.4% |
| CR: 13.9% vs 4.6% |
| mPFS: 16.4 mos vs 8.3 mos (HR 0.58 [0.49-0.70]) |
| mOS: 46.5 mos vs 35.5 mos (HR 0.79 [0.65-0.96])
|
Safety
|
Grade >=3 AEs: 67.8% vs 55.0% |
| Hypertension (13.1% vs 12.5%) |
| Palmar-plantar erythrodysesthesia (7.8% vs 8.1%) |
| Diarrhea (7.2% vs 4.7%) |
| Treatment discontinuation due to AEs: 28.1% vs 10.9%
|
Ann Oncol. Published online September 2025
Motzer RJ, Escudier B, Burotto M New Reference: Nivolumab + Cabozantinib for 1st Line RCC
http://doi.org/10.1016/j.annonc.2025.09.006
Reviewed by Ulas D. Bayraktar, MD on Oct 19, 2025
