Tivozanib in Patients with Advanced Renal Cell Carcinoma Previously Treated With Axitinib: Subgroup Analysis from TIVO-3

Background In phase III TIVO-3 trial, tivozanib improved progression-free survival (PFS) compared to sorafenib for patients with metastatic renal cell carcinoma (mRCC). However, the effectiveness of this drug after exposure to other selective VEGFR agents has not yet been defined. Herein, we characterize the clinical efficacy of tivozanib in patients with mRCC previously treated with axitinib. Methods We identified patients from the intention to treat (ITT) population, in the TIVO-3 trial, who received treatment with axitinib before enrolment in the study and evaluated PFS, response rate (RR), and safety. Results Out of 350 patients, 172 (83:89, tivozanib:sorafenib) had received prior treatment with axitinib in TIVO-3. In this subgroup, PFS was 5.5 months with tivozanib and 3.7 months with sorafenib (HR 0.68). RR was 13% and 8% favoring tivozanib. Conclusions Tivozanib is active in the treatment of patients with mRCC who have progressed on prior therapies, including axitinib.Results of the TIVO-3 trial suggested that tivozanib has a progression-free survival advantage compared with sorafenib; however, it has been speculated that prior use of axitinib (which bears mechanistic resemblance to tivozanib) renders tivozanib less effective. This article examines the TIVO-3 dataset for outcomes of patients with prior axitinib therapy.