Tivozanib Versus Sorafenib in Patients with Advanced Renal

Tivozanib Versus Sorafenib in Patients with Advanced Renal Cell Carcinoma (TIVO-3): A Phase 3, Multicentre, Randomised, Controlled, Open-Label Study

Tivozanib Versus Sorafenib in Patients with Advanced Renal Cell Carcinoma (TIVO-3): A Phase 3, Multicentre, Randomised, Controlled, Open-Label Study

On March 10, 2021, the FDA approved tivozanib for “adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.” Results were based off the TIVO-3 trial, which was reported in the January 1, 2021 edition of The Lancet.

Tivozanib is a small molecule inhibitor of the VEGFR. TIVO-3 is a randomized, open label, multicenter trial versus sorafenib in patients with relapsed or refractory advanced renal cell carcinoma, who had progressed on 2 or 3 prior systemic therapies. One of the agents had to be a VEGFR inhibitor. Patients were randomized to 1.34 mg once daily of tivozanib on 21 out of 28 days or sorafenib 400 mg twice a day.

Patients were treated until disease progression. The median progression free survival was 5.6 months versus 3.9 months. The hazard ratio was 0.73, 95% confidence interval 0.56–0.95, P = 0.016.

The median overall survival was 16.4 versus 19.2 months, hazard ratio 0.97. The objective response rate was 18% versus 8%. The most common adverse events included fatigue, diarrhea, hypertension and decreased appetite. The most common grade 3 or 4 laboratory abnormalities including hyponatremia, increased lipase and hypophosphatemia. 

Reference:

Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30735-1/fulltext

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