New Reference: Nivolumab and Cabozantinib for Advanced RCC
Study
Open-label, randomised, phase 3 trial (CheckMate 9ER)
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Previously untreated advanced or metastatic clear-cell renal cell carcinoma
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Nivolumab 240 mg/2 weeks plus cabozantinib 40 mg/day (N:323) or sunitinib 50 mg/day, 4 weeks per 6-week cycle (N:328)
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Efficacy
mOS:37·7 m vs 34·3 m (HR:0·70 [95% CI 0·55–0·90], p=0·0043)
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mPFS:16·6 m vs 8·3 m (HR 0·56 [95% CI 0·46−0·68], p<0·0001)
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Safety
Grade >= 3 AEs: 65% vs 54%
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Grade >=3 AEs: HT 13% vs 12%, palmar–plantar erythrodysaesthesia 8% vs 8%, diarrhoea 7% vs 5%
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Treatment-related serious AEs 22% vs 10%
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One treatment-related death occurred with sunitinib
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Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): long-term follow-up results from an open-label, randomised, phase 3 trial
Reviewed by Hasan Cagri Yildirim, MD on Sep 20, 2022