Final results from the phase 3 CheckMate-9ER trial show that cabozantinib (CABOMETYX) combined with nivolumab (Opdivo) continues to demonstrate a survival benefit compared to sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC) after more than five years of follow-up. The combination therapy improved both progression-free survival (PFS) and overall survival (OS) compared to sunitinib. These findings, including subgroup analyses, were presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.

This long-term data reinforces the established role of the cabozantinib-nivolumab combination as a first-line treatment for advanced RCC. The sustained efficacy observed over five years provides clinicians and patients with greater confidence in the long-term benefits of this treatment approach, which is particularly crucial in a disease setting where long-term survival is a primary goal. Demonstrating durable efficacy can influence treatment guidelines and further solidify the combination’s position as a preferred first-line option.

The combination therapy showed a statistically significant improvement in PFS (HR: 0.58) and OS (HR: 0.79) compared to sunitinib. Subgroup analyses by IMDC risk and baseline metastasis sites (liver, bone, and lung) consistently favored the combination across all groups, indicating broad applicability of the treatment. The objective response rate (ORR) was also higher with the combination therapy (55.7%) versus sunitinib (27.4%). Safety and tolerability profiles remained consistent with previous reports, with no new safety signals identified in the long-term follow-up.

This five-year follow-up data strengthens the position of cabozantinib plus nivolumab as a standard of care in first-line advanced RCC. The consistent efficacy across subgroups highlights its potential to benefit a diverse patient population. This data is likely to continue influencing treatment decisions and potentially expand the use of this combination therapy in the future.

Source link: http://www.businesswire.com/news/home/20250214191927/en/Exelixis-Announces-Final-Five-Year-Follow-up-Results-from-CheckMate–9ER-Trial-Evaluating-CABOMETYX%C2%AE-cabozantinib-in-Combination-with-Opdivo%C2%AE-nivolumab-in-Patients-with-Advanced-Kidney-Cancer-at-ASCO-GU-2025

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.