AVEO Announces TIVO-3 Passes The First Safety Monitoring Committee Safety Review
CAMBRIDGE, Mass. -- AVEO Oncology (NASDAQ:AVEO) today announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment.
As recently announced, the TIVO-3 trial is enrolling substantially ahead of schedule, and with the SMC recommendation to replace early dropouts the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support regulatory approval of tivozanib in the U.S. as first and third line treatment for RCC.
- Published: 23 February 2017
- Written by Editor