AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today announced plans to initiate a new clinical study, TAURUS ( Tivoz Anib Use ve Rs Us Sutent in advanced renal cell carcinoma (RCC): Patient Preference), to establish additional data regarding the investigational drug tivozanib when used as first-line therapy in patients with advanced RCC. The TAURUS study will enroll patients at sites throughout the United States and Western Europe.
“With more treatment options available for patients living with cancer, it's becoming increasingly critical to understand how patient preference is influenced by side effects and other related issues,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “Following the positive findings from the Phase 3 TIVO-1 trial, the TAURUS study will allow us to further define the tolerability profile of tivozanib and understand the role that tivozanib could play in the treatment of first line advanced kidney cancer compared to a standard of care drug.”
“Patients and their healthcare providers are looking for anti-cancer agents that are more effective and better tolerated than existing therapeutic options,” said Bernard Escudier, M.D., principal investigator for TAURUS, Institut Gustave Roussy, “The TAURUS study will help us better understand how the side effect profiles of drugs affect patients’ treatment choices. The typical patient being treated for metastatic kidney cancer is middle-aged, active and is still in the work force and therefore the impact of side effects may be more important to them.”
“The TAURUS trial will help us better understand patient preference in selecting kidney cancer treatment options,” stated Steven Ryder, M.D., president, Astellas Pharma Global Development. “The study supports Astellas’ goal of leadership in oncology and our commitment to improving patient care.”TAURUS is a randomized (1:1), double-blind, crossover controlled, multi-center Phase 2 study comparing tivozanib versus sunitinib in approximately 160 patients with advanced RCC who have received no prior systemic therapy. The primary objective of the study is to compare patient preference after receiving both tivozanib and sunitinib in sequence. Secondary objectives are to evaluate the incidence of treatment-emergent Grade 3/4 adverse events (AEs) and serious adverse events (SAEs); frequency of dose modifications; and quality of life in patients treated with tivozanib versus sunitinib.