First-line treatment of advanced renal cell carcinoma (RCC) -- Bristol-Myers Squibb / Exelixis
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Final #CheckMate9ER results (5+ yr FU: N+C > S in 1L #aRCC PFS HR 0.58, OS HR 0.79, ORR 55.7% vs 27.4%. No new safety signals. N+C remains a SOC for untreated aRCC. @ASCO #GU25 @motzermd @tompowles1 @MSKCancerCenter @OncoAlert
Congrats to @DrChoueiri @motzermd for developing one of the most effective combinations cabozantinib + nivolumab for mRCC #kidneycancer Checkmate 9ER phase 3 trial continued strong OS benefit @tompowles1 @AlbigesL @asco #GU25
5 year update of checkmate 9ER. Nivo plus Cabo vs Sunitinib for advanced clear cell RCC. Note that Sunitinib arm is not doing bad either. 35.4 % are alive on Sunitinib arm also at the end of 5 years. ( vs 40.9 % on nivo plus Cabo arm ) gap between two has narrowed . Any views
Excellent analysis by our very own @CharleneMantia of survival states over 4 years in #CheckMate9ER comparing 1L Nivo + Cabo vs. Sun in pts w/ aRCC! #ASCO24 Over the 4-year period since initiation of 1L therapy, the longer OS with Nivo+Cabo was accompanied by 1.5 times
Final analysis of Checkmate 9ER in @Annals_Oncology : 1L mRCC trial
Ab#439 @ASCO #GU25 by #RobertMotzer Final results of CheckMate 9ER #kidneycancer Median OS 46.5 vs 35.5 mo w/ 1L Cabo+Nivo vs sunitinib @DrChoueiri @OncoAlert @urotoday @KidneyCancer @Uromigos @kidneycan
CheckMate 9ER: 5-Year Final Analysis Nivo + Cabo (N+C) outperforms Sunitinib (S) in 1L aRCC PFS: 16.4 vs 8.3 mo OS: 46.5 vs 35.5 mo ORR: 56% vs 27%, CR: 14% vs 5% @motzermd @MSKCancerCenter #GU25 @asco #kidneycancer
@ASCO #GU25 | Abstract #439 Presented by: @motzermd Key authors: @tompowles1, @DrChoueiri @OncoAlert Final 5-year results from CheckMate 9ER: PFS: 16.4 vs. 8.3 months (HR 0.58, 95% CI 0.49-0.70) OS: 46.5 vs. 35.5 months (HR 0.79, 95% CI 0.65-0.96)
@ASCO #GU25: CheckMate 9ER (5+ year follow-up): Nivolumab + Cabozantinib continues to show durable efficacy in 1L advanced RCC vs. Sunitinib. No new safety signal! @motzermd @ASCOPost @ASCOTECAG @OncoAlert
Final updates of #CheckMate 9ER trial? nivolumab + cabozantinib vs sunitinib in 1L advanced RCC @ASCO #GU25 Key Takeaways, nivolumab with cabozantinib: Improved PFS in ITT 16.4m vs 8.3m HR 0.58 Improved OS in ITT 46.5m vs 35.5m HR 0.79 Doubled ORR 55.7% vs 27.4%
CheckMate-9ER is a phase 3, randomized, open-label trial evaluating nivolumab (Opdivo) plus cabozantinib (Cabometyx) versus sunitinib in 651 previously untreated patients with advanced clear cell renal cell carcinoma across all IMDC risk groups. The combination demonstrated statistically significant improvements in PFS, OS, and ORR compared to sunitinib, leading to FDA approval in January 2021. Final 5.5-year follow-up data presented at ASCO GU 2025 confirm durable benefit with median PFS of 16.6 vs 8.3 months (HR 0.58) and median OS of 46.5 vs 35.5 months (HR 0.79), establishing nivo+cabo as a standard of care for first-line advanced RCC.
Phase 3, randomized 1:1, open-label trial. Stratified by IMDC risk score, tumor PD-L1 expression, and geographic region. Median follow-up 67.6 months (final analysis).
651 previously untreated patients with advanced or metastatic clear cell RCC across all IMDC risk groups (favorable, intermediate, and poor).
Nivolumab 240 mg IV Q2W + cabozantinib 40 mg PO daily vs sunitinib 50 mg PO daily (4 weeks on / 2 weeks off). Treatment until progression or unacceptable toxicity.
PFS per BICR (RECIST v1.1). Key secondary: OS, ORR per BICR, and safety.
Nivolumab + cabozantinib doubled median PFS compared to sunitinib: 16.6 months vs 8.3 months (HR 0.51, 95% CI: 0.41-0.64, p<0.0001). At the final 5.5-year analysis, the PFS benefit remained durable with HR 0.58 (95% CI: 0.49-0.70). ORR was 55.7% vs 27.1-27.4%, with complete response rates of 13.9% vs 4.6%. Median duration of response was 22.0 vs 15.2 months.
At primary analysis, OS HR was 0.60 (98.89% CI: 0.40-0.89, p=0.001) favoring nivolumab + cabozantinib. Final 5.5-year follow-up showed median OS of 46.5 vs 35.5 months (HR 0.79, 95% CI: 0.65-0.96). The 60-month OS rates were 40.9% vs 35.4%. Notably, in the favorable-risk subgroup, no OS benefit was observed (53.7 vs 58.9 months, HR 1.08), a finding that continues to be debated among KOLs.
Grade 3/4 treatment-related adverse events occurred in 68% of the nivo+cabo arm vs 55% with sunitinib. Treatment discontinuation due to adverse events was higher with the combination (15.3% vs 8.8%). Common adverse events included diarrhea, hypertension, and hepatotoxicity (ALT/AST elevation). Safety was manageable with dose modifications, and no new safety signals emerged at 5.5-year follow-up. The cabozantinib dose was reduced to 40 mg (from standard 60 mg) when combined with nivolumab.
CheckMate-9ER final data confirm nivolumab + cabozantinib as a durable first-line standard of care for advanced RCC (NCCN Category 1 preferred). The combination is one of several IO-TKI options competing in 1L RCC, alongside CLEAR (lenvatinib + pembrolizumab) and KEYNOTE-426 (pembrolizumab + axitinib). Treatment selection depends on risk group, toxicity profile, and physician preference. The favorable-risk debate -- whether IO-TKI is needed over TKI monotherapy -- remains an active area of discussion among GU oncology KOLs.