AVEO Reports Presentation of Final Results of Extension Study 902, FDA Regulatory Feedback for Advancing Tivozanib in Renal Cell Carcinoma

AVEO Oncology

announced today that final results from the TIVO-1 extension study, known as Study 902, in which patients with advanced renal cell carcinoma (RCC) received tivozanib as second-line treatment subsequent to disease progression on sorafenib in the Company's Phase 3 TIVO-1 first-line RCC study, will be presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. The Company previously reported interim median progression free survival (PFS) results of 8.4 months among the 163 patients enrolled in Study 902. Final results now show a median PFS in this setting of 11.0 months and median overall survival (OS) of 21.6 months, demonstrating the efficacy of tivozanib in a VEGF treatment refractory population. AVEO also announced today that it has received a written response from the U.S. Food and Drug Administration (FDA) stating that a phase 3 study outlined by the Company, in patients with RCC who have failed at least two prior regimens, including VEGF therapy, "may support AVEO's proposed indication for tivozanib in the 3rd line setting." In response to whether the study, together with the TIVO-1 study, would be sufficient to support licensure of tivozanib as a treatment for advanced RCC, the FDA indicated: "whether the results from this [third line] study can support AVEO's proposal for tivozanib in the first line setting is a review issue." The study design shared with the FDA is a randomized, controlled, multi-center, open-label Phase 3 study of approximately 314 subjects randomized 1:1 to receive either tivozanib or sorafenib. Subjects enrolled in the study may include those who have received prior immunotherapy, including immune checkpoint (PD-1) inhibitors, reflecting a potentially evolving treatment landscape. The primary objective of the study would be PFS. Secondary objectives would include OS and objective response rate (ORR) as well as safety and pharmacokinetic endpoints. "Based on TIVO-1, where tivozanib led to a longer progression free survival than sorafenib in the first line, combined with the activity tivozanib demonstrated in patients who have progressed on a VEGF therapy, we are optimistic about the probability of a successful clinical outcome in a third line RCC study," said Michael Bailey, president and chief executive officer of AVEO. "We are also encouraged by the FDA's willingness to consider whether a refractory study can serve as a confirmatory study for TIVO-1 in first line RCC. Prior to committing to a new study, we will continue to evaluate all options, including partnerships, for the clinical and regulatory advancement for tivozanib in RCC as well as colorectal cancer." ASCO Presentation Details Efficacy results from Study 902 and final results from the TIVO-1 trial will be presented at the 2015 ASCO Annual Meeting being held May 29 – June 2, at McCormick Place in Chicago, Illinois. Details of the presentation are as follows: Date & Time: Monday June 1, 1:15 PM to 4:45 PM Poster Title: Tivozanib vs sorafenib targeted therapy for advanced renal cell carcinoma: Final results of a phase III trial (901) and efficacy results of a 2nd line tivozanib extension study (902) Abstract Number: 4557 Poster Board: #231 Session: Genitourinary (Nonprostate) Cancer Location: S Hall A The full abstract can be viewed here.