A phase III, randomized, controlled study to compare tivozanib with sorafenib in patients (pts) with advanced renal cell carcinoma (RCC).

• DOI: 10.1200/jco.2011.29.7_suppl.310
• Publication Date: 2017-02-23T18:54:21Z
• Authors: R. J. Motzer; P. Bhargava; B. Esteves; M. Al-Adhami; W. Slichenmyer; D. Nosov; T. Eisen; C. N. Sternberg; T. E. Hutson
• Keywords: Clinical endpoint; Discontinuation

310 Background: Drugs that block vascular endothelial growth factor (VEGF) pathway signaling, such as the tyrosine kinase inhibitor sorafenib, have become standard treatment for pts with RCC. Tivozanib (AV-951) is a potent, selective small-molecule pan-VEGF receptor (VEGFR) inhibitor, activity against VEGFR-1, -2, and -3 kinases at subnanomolar concentrations. Preliminary results from phase II randomized discontinuation trial of tivozanib (1.5 mg/d; 3 wks on, 1 wk off) in RCC demonstrated an objective response rate (ORR) 27% median progression-free survival (PFS) 11.8 mo by independent radiology review, favorable safety profile. Patients clear cell who had undergone nephrectomy ORR 32% PFS 14.8 (Bhargava, et al. ASCO 2010. Abstract 4599). Based on this antitumor III, randomized, controlled, global, multicenter currently progress to compare sorafenib advanced Methods: Approximately 500 adults received ≤ prior systemic (no VEGF-targeted therapy) were 1:1 or sorafenib. Pts are receiving 1.5 mg/d orally 4-week cycles (3 continuous 400 mg twice daily. The primary endpoint will be review; secondary endpoints include overall survival, ORR, duration response. Safety being monitored through adverse event reporting laboratory analyses; toxicities graded using NCI Common Terminology Criteria Adverse Events, version 3.0. effect therapy health-related quality life compared between arms kidney cancer-specific (FKSI-DRS), oncology (FACT-G), general (EQ-5D) assessments. Pharmacokinetics biomarker analyses performed. Results: Pending. Conclusions: Enrollment completed August An ongoing extension study allow access demonstrate progressive disease well long-term clinical benefit. [Table: see text]