Nivolumab plus cabozantinib vs sunitinib for first-line treatment of advanced renal cell carcinoma (aRCC): 3-year follow-up from the phase 3 CheckMate 9ER trial.

• DOI: 10.1200/jco.2023.41.6_suppl.603
• Publication Date: 2023-03-14T15:22:32Z
• Authors: Mauricio Burotto; Thomas Powles; Bernard Escudier; Andrea B. Apolo; Maria Teresa Bourlon; Amishi Yogesh Shah; Cristina Suárez; Camillo Porta; Carlos H. Barrios; Martin Richardet; Howard Gurney; Elizabeth R Kessler; Yoshihiko Tomita; Jens Bedke; Saby George; Christian Scheffold; Peter Wang; Viktor Fedorov; Robert J. Motzer; Toni K. Choueiri
• Keywords: Cabozantinib; Clinical endpoint; Progression-free survival

603 Background: First-line nivolumab plus cabozantinib (N+C) demonstrated superiority over sunitinib (S) with 25.4 mo minimum follow-up (median, 32.9 mo) in patients (pts) aRCC the CheckMate 9ER trial. Here, we report survival, response per blinded independent central review (BICR), and safety after 3 y all randomized pts by IMDC risk score. Methods: Pts were 1:1 (stratified score, tumor PD-L1 expression, region) to N 240 mg flat dose IV Q2W + C 40 PO QD vs SUN 50 for 4 wk (6-wk cycles) until disease progression or unacceptable toxicity (max treatment, 2 y). Primary endpoint: progression-free survival (PFS) BICR. Secondary endpoints: overall (OS), objective rate (ORR) BICR, safety. Results: In total, 323 N+C 328 S. With 36.5 44.0 mo), PFS OS benefits maintained S intent-to-treat pts. Median was 16.6 8.4 (HR 0.59 [95% CI 0.49–0.71], P < 0.0001) median 49.5 35.5 0.70 0.56–0.87], = 0.0014). ORR (95% CI) higher (56% [50–62] 28% [23–33]), 13% 5% of achieved complete (CR), respectively. duration 22.1 16.1 PFS, OS, are reported across prespecified groups table. Any-grade treatment-related adverse events (TRAEs) occurred 97% 93% treated (grade ≥ TRAE, 67% 55%). TRAEs led discontinuation only 10% pts, 7% 11% Conclusions: After follow-up, remained consistent previous follow-ups. improved 11.8 since data cut. Responses durable, CR rates regardless group. No new signals emerged additional either arm. These results continue support as a first-line treatment aRCC. Clinical trial information: NCT03141177 . [Table: see text]