AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) reported the conclusion of a pre-planned futility assessment of the Phase III TIVO-3 study, the firm’s randomized, controlled, open-label trial to compare FOTIVDA® to sorafenib in people with refractory advanced RCC. Dependent on the data of the futility assessment, which was assessed by an independent statistician, the trial will continue as intended without modification.
This assessment did not permit for early stopping following efficacy to ascertain adequate follow-up for the major secondary objective of overall survival. The pre-intended futility assessment was led by the reporting of 128 progression events in August. Additional events were reported as part of the data management procedure leading into the futility assessment, leading in a new data cut-off date for the assessment of May 29. The firm continues to anticipate the TIVO-3 trial read out in the Q1 2018.
The details
The TIVO-3 trial, coupled with the initially closed TIVO-1 study of tivozanib in the initial line treatment of RCC, is intended to support regulatory nod of tivozanib in the United States as a third and first line treatment for RCC. Michael Bailey, the CEO and President of AVEO, reported that the treatment of developed renal cell cancer is witnessing rapid change, with combination regimens and immunotherapy offering improved results for patients and outlining a new treatment paradigm.
Bailey added that they consider their tivozanib clinical strategy positions them well in this growing landscape, with the TIVO-3 trial on track to offer the initial post-immunotherapy major datasets for a VEGF-TKI, and the TiNivo trial offering early and promising combination data. They look forward to data of the TIVO-3 study in the Q1 2018. They anticipate presenting Phase 1 data from the Phase 1/2 TiNivo trial of tivozanib together with OPDIVO® at a medical event this fall, and to using tivozanib’s unique efficacy and safety profile in future prospective therapy combinations.
