| Title: |
Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial. |
| Authors: |
Motzer, RJ; Escudier, B; George, S; Hammers, HJ; Srinivas, S; Tykodi, SS; Sosman, JA; Plimack, ER; Procopio, G; McDermott, DF; Castellano, D; Choueiri, TK; Donskov, F; Gurney, H; Oudard, S; Richardet, M; Peltola, K; Alva, AS; Carducci, M; Wagstaff, J; Chevreau, C; Fukasawa, S; Tomita, Y; Gauler, TC; Kollmannsberger, CK; Schutz, FA; Larkin, J; Cella, D; McHenry, MB; Saggi, SS; Tannir, NM |
| Contributors: |
Larkin, James |
| Publisher Information: |
WILEY |
| Publication Year: |
2026 |
| Collection: |
The Institute of Cancer Research (ICR): Publications Repository |
| Subject Terms: |
CheckMate 025; advanced renal cell carcinoma (aRCC); everolimus; immune checkpoint inhibitor; nivolumab; previously treated; Antineoplastic Combined Chemotherapy Protocols; Carcinoma; Renal Cell; Female; Follow-Up Studies; Humans; Kidney Neoplasms; Male; Treatment Outcome |
| Subject Geographic: |
United States |
| Description: |
BACKGROUND: CheckMate 025 has shown superior efficacy for nivolumab over everolimus in patients with advanced renal cell carcinoma (aRCC) along with improved safety and tolerability. This analysis assesses the long-term clinical benefits of nivolumab versus everolimus. METHODS: The randomized, open-label, phase 3 CheckMate 025 trial (NCT01668784) included patients with clear cell aRCC previously treated with 1 or 2 antiangiogenic regimens. Patients were randomized to nivolumab (3 mg/kg every 2 weeks) or everolimus (10 mg once a day) until progression or unacceptable toxicity. The primary endpoint was overall survival (OS). The secondary endpoints were the confirmed objective response rate (ORR), progression-free survival (PFS), safety, and health-related quality of life (HRQOL). RESULTS: Eight hundred twenty-one patients were randomized to nivolumab (n = 410) or everolimus (n = 411); 803 patients were treated (406 with nivolumab and 397 with everolimus). With a minimum follow-up of 64 months (median, 72 months), nivolumab maintained an OS benefit in comparison with everolimus (median, 25.8 months [95% CI, 22.2-29.8 months] vs 19.7 months [95% CI, 17.6-22.1 months]; hazard ratio [HR], 0.73; 95% CI, 0.62-0.85) with 5-year OS probabilities of 26% and 18%, respectively. ORR was higher with nivolumab (94 of 410 [23%] vs 17 of 411 [4%]; P < .001). PFS also favored nivolumab (HR, 0.84; 95% CI, 0.72-0.99; P = .0331). The most common treatment-related adverse events of any grade were fatigue (34.7%) and pruritus (15.5%) with nivolumab and fatigue (34.5%) and stomatitis (29.5%) with everolimus. HRQOL improved from baseline with nivolumab but remained the same or deteriorated with everolimus. CONCLUSIONS: The superior efficacy of nivolumab over everolimus is maintained after extended follow-up with no new safety signals, and this supports the long-term benefits of nivolumab monotherapy in patients with previously treated aRCC. LAY SUMMARY: CheckMate 025 compared the effects of nivolumab (a novel immunotherapy) with ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
Print-Electronic; 4167; application/pdf |
| Language: |
English |
| ISSN: |
1097-0142; 0008-543X |
| Relation: |
Cancer, 2020, 126 (18), pp. 4156 - 4167; https://repository.icr.ac.uk/handle/internal/7477 |
| DOI: |
10.1002/cncr.33033 |
| Availability: |
https://doi.org/10.1002/cncr.33033; https://repository.icr.ac.uk/handle/internal/7477 |
| Rights: |
http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.3E3B483 |
| Database: |
BASE |