
SUMMARY
Cabozantinib Ipsen, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults1.
The CheckMate 9ER trial is a phase 3, randomised, open-label trial assessing Cabozantinib + nivolumab vs. sunitinib in patients with previously untreated advanced renal cell carcinoma (aRCC).
Early tumour control with sustained long-term overall survival demonstrated by Cabozantinib + nivolumab vs sunitinib, in the 68-month CheckMate 9ER follow-up, in patients with previously untreated advanced renal cell
carcinoma (aRCC).2,3
Sustained long-term overall survival at 67.6 months versus sunitinib3
Established patient safety and tolerability profile2,3
An established safety profile with no new safety signals compared with the previous cut-off was seen in the 67.6-month follow-up.2,3
Discontinuation rates due to TRAEs with Cabozantinib + nivolumab were 6% simultaneously and 1% sequentially, 11% for Cabozantinib alone, 10% for nivolumab alone and 11% with sunitinib.3
One tablet, once a day with adjustable dosing1
Cabozantinib is taken as one tablet, once daily with a recommended starting dose of 40 mg when administered in combination with nivolumab.1 Management of suspected adverse drug reactions may require temporary treatment interruption and/or dose reduction.1
Dosing can be reduced to 20 mg once daily, then 20 mg every other day to manage TRAEs, if required.1
‡ Disease control calculated as patients in ITT population achieving CR + PR + SD (CR: 13.9%; PR: 41.8%; SD: 32.2%); §If required.
Abbreviations:
VEGF, vascular endothelial growth factor; IO, immunotherapy; TKI, tyrosine kinase inhibitor; aRCC,
advanced renal cell carcinoma; mPFS, median progression-free survival; HR, hazard ratio; CI,
confidence interval; ORR, objective response rate; CR, complete response; ITT, intention-to-treat;
mOS, median overall survival; TRAE, treatment-related adverse event.
References:
1. Cabozantinib Summary of Product Characteristics.
2. Motzer R et al. Presented at ASCO GU 2025. Abstract 439.
3. Ipsen Data on File. CBZ-UK-000439.
CBZ-UK-000470 | March 2025