Study
| Phase 2, multicenter, randomized trial (SUNNIFORECAST) |
| Previously untreated advanced/metastatic non-clear cell RCC |
| Ipilimumab + nivolumab (4 cycles) followed by nivolumab maintenance vs. standard of care (TKI or TKI + ICI) |
Efficacy
| ORR: 32.8% vs. 19.3% |
| CR: 8% vs. 2% |
| mDoR: 11.1 mos vs. not reported |
| mPFS: 5.4 mos vs. 5.7 mos (HR: 0.99 [0.77-1.28]) |
| mOS: 33.2 mos vs. 25.2 mos (HR: 0.81 [0.61-1.09]) |
| 12-mo OS: 78% vs. 68% |
| 18-mo OS: not reported |
| Exploratory OS (CPS ≥1): HR: 0.56 [0.37-0.86] |
Safety
| Grade ≥3 AEs: Treatment-related AEs (87% vs. 96%), serious AEs (48% vs. 39%) |
| Treatment-related discontinuations: 17% vs. 9% |
| Fatal events: 5 pts vs. 3 pts (not treatment-related) |
Ann Oncol. Accepted 24 Mar 2025
http://doi.org/10.1016/j.annonc.2025.03.016
Reviewed by Ulas D. Bayraktar, MD on Apr 7, 2025
