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New Reference: Nivolumab + cabozantinib for previously untreated advanced clear cell renal cell carcinoma

New Reference: Nivolumab + cabozantinib for previously untreated advanced clear cell renal cell carcinoma
Study:
  • Randomized, open-label phase III trial (TIVO-3)
  • Previously untreated RCC with clear cell component
  • Cabozantinib 40 daily + nivolumab 240 q14 (n=323) vs. sunitinib 50 daily 4/6 wks (n=328), all until disease progression
Efficacy:
  • CR: 8.0% vs. 4.6%
  • ORR: 55.7% vs. 27.1% (p<0.001)
  • Median DoR: 20.2 mos [17.3-NE] vs. 11.5 mos [8.3-18.4]
  • Median PFS: 16.6 vs. 8.3 mos (HR: 0.51 [0.41-0.64])
  • OS @ 1yr: 85.7% vs. 75.6% mos (HR: 0.60 [0.40-0.89])
Safety:
  • Grade >=3 AEs: diarrhea (6.9% vs. 4.4%), PPE (7.5% vs. 7.5%), hypertension (12.5% vs. 13.1%), increased ALT (5.3% vs. 2.2%)

N Engl J Med 2021;384:829-41

Choueiri TK, et al. Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma

https://doi.org/10.1056/NEJMoa2026982

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