(ChemotherapyAdvisor) – The potent and selective VEGFR-1, -2, -3 inhibitor tivozanib (AV-951) is active and well-tolerated in patients with advanced and metastatic renal cell carcinoma (RCC), according to Phase 2 study results in the Journal of Clinical Oncology online on April 9.
Of 272 patients enrolled in the study, 83% had clear-cell histology, 73% had undergone nephrectomy, and 54% were treatment-naïve. Patients were randomized to receive oral tivozanib 1.5mg/day for three weeks followed by one week off for 16 weeks. Thereafter, the 78 patients who demonstrated ≥25% tumor shrinkage continued to take tivozanib, the 118 patients with <25% tumor change were randomly assigned to tivozanib or placebo, and those with ≥25% tumor growth were discontinued.
Following 16 weeks of treatment with tivozanib, the objective response rate (ORR) was 18%. Significantly more of the 118 patients who received tivozanib remained progression free after 12 weeks compared with those who received placebo (49% vs. 21%; P<0.001.) In the overall study population, ORR was 24% and median progression-free survival was 11.7 months.
Hypertension (12%) was the most common grade 3-4 treatment-related adverse event.
The investigators concluded that these results “support the ongoing Phase 3 evaluation of tivozanib in patients with advanced or metastatic clear-cell RCC.”