Metastatic renal cancer: later-line tivozanib tops sorafenib for PFS

  • Rini BI & et al.
  • Lancet Oncol.
  • 3 Dec 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Tivozanib as third- or fourth-line therapy improved PFS and showed a favorable safety profile vs sorafenib in patients with refractory metastatic renal cell carcinoma (RCC).
  • PFS benefit was maintained in patients previously treated with checkpoint inhibitors.
  • PFS was not significantly different in poor-risk patients.

Why this matters

  • Low incidence of class-related toxicities and PFS advantage support tivozanib in this setting.

Study design

  • Multinational phase 3 TIVO-3 trial of 350 patients (median age, 63 years) with refractory metastatic RCC were randomly assigned to receive tivozanib (n=175) or sorafenib (n=175).
  • Funding: AVEO Oncology.

Key results

  • Median follow-up was 19.0 months.
  • Median PFS was significantly longer with tivozanib (5.6 vs 3.9 months; HR, 0.73; P=.016) vs sorafenib.
    • PFS benefit was maintained in a patient subgroup that previously received checkpoint inhibitors (7.3 vs 5.1 months; HR, 0.55; P=.028).
  • PFS was not significantly different in poor-risk patients (HR, 1.15; 95% CI, 1.8-3.5).
  • In the tivozanib vs sorafenib group:
    • The most common grade 3-4 treatment-related adverse event was hypertension (20% vs 14%).
    • The serious treatment-related adverse event rate was 11% vs 10%.
  • No treatment-related deaths were reported.

Limitations

  • Open-label design.