Clinical Trial Review: CheckMate 9ER
Panelists discuss how CheckMate 9ER results demonstrated significant progression-free survival and overall survival benefits with nivolumab plus cabozantinib vs sunitinib, with particularly impressive HRs for patients with visceral disease, including liver, bone, and lung metastases.
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CheckMate 9ER established nivolumab plus cabozantinib as a potent immunotherapy-tyrosine kinase inhibitor (IO-TKI) combination, with 651 patients with untreated advanced clear cell renal cell carcinoma randomly assigned to receive combination therapy vs sunitinib.Ramalingam presents the 67-month follow-up data showing progression-free survival benefit with a HR of 0.58, median progression-free survival of 16 vs 8 months, and benefits across all International Metastatic RCC Database Consortium risk categories. Overall survival improvement achieved a HR of 0.79, with 60-month survival rates of 41% vs 35% for combination vs sunitinib, respectively.
The combination demonstrated a 55% overall response rate compared with 27% with sunitinib, with duration of response at 60 months reaching 22% vs 10%, respectively. Notably, survival signals appeared more pronounced in poor-risk populations, consistent with patterns observed across IO-TKI trials. Grade 3 treatment-related adverse events occurred in 67% of patients receiving the combination treatment vs 55% with sunitinib, reflecting the additive toxicity of combining immunotherapy with cabozantinib's broader kinase inhibition profile.
Site-specific metastasis analysis reveals particularly impressive HRs for visceral disease: liver metastases (0.55), bone metastases (0.43), and lung metastases (0.56). This data supports cabozantinib's positioning for patients with bone-dominant disease, building upon historical METEOR trial data showing superior bone disease control. The 40 mg cabozantinib dose combination (vs 60 mg monotherapy) represents a strategic dose reduction for tolerability while maintaining efficacy end points. Quality-of-life benefits favor the combination over sunitinib, supporting its use in patients who are symptomatic, requiring rapid disease control, particularly those with bone or liver involvement where cabozantinib demonstrates enhanced activity.
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