Kidney Neoplasm
Nivolumab plus cabozantinib shows a long‑term survival benefit over sunitinib in first‑line treatment of advanced renal cell carcinoma
BACKGROUND: Nivolumab plus cabozantinib (NIVO+CABO) showed significant benefits over sunitinib (SUN) in progression‑free survival (PFS), overall survival (OS), and objective response rate (ORR) for previously untreated advanced renal cell carcinoma (RCC) in the phase III CheckMate 9ER trial (NCT03141177). We report final, updated efficacy and safety results with median follow‑up of 5.6 years. PATIENTS AND METHODS: Patients with advanced RCC were randomized to first‑line NIVO 240 mg intravenously every 2 weeks plus CABO 40 mg p.o. o.d. or SUN 50 mg p.o. o.d. until disease progression or unacceptable toxicity. The primary endpoint was PFS per RECIST v1.1 by blinded independent central review. RESULTS: Median follow‑up was 5.6 years. In intent‑to‑treat patients, PFS favored NIVO+CABO versus SUN (HR 0.58, 95% CI 0.49–0.70). Median PFS was 16.4 versus 8.3 months; 60‑month PFS rates were 13.6% versus 3.6%. OS favored NIVO+CABO versus SUN (HR 0.79, 95% CI 0.65–0.96). Median OS was 46.5 versus 35.5 months; 60‑month OS rates were 40.9% versus 35.4%. ORR was greater with NIVO+CABO versus SUN (55.7% versus 27.4%; CR 13.9% versus 4.6%). The probability of remaining in response through 60 months was 22.0% versus 10.0%. Treatment‑related adverse events occurred in 97.5% versus 93.1% of patients. CONCLUSIONS: Long‑term efficacy benefit was observed with NIVO+CABO over SUN and safety was consistent with previous reports. These results reaffirm NIVO+CABO as a standard of care for previously untreated advanced RCC.
The study establishes nivolumab plus cabozantinib as a more effective first‑line therapy for advanced renal cell carcinoma, providing improved progression‑free and overall survival, and reshaping standard treatment guidelines for this malignancy.
Evidence level: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.
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