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AVEO

Aveo Pharmaceuticals

$0.74

-0.0239 (-3.13%)

07:01
06/20/17
06/20
07:01
06/20/17
07:01

AVEO says Phase 3 TIVO-3 study reaches enrollment target ahead of schedule

AVEO Oncology announced that the company's pivotal TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma has reached its enrollment target of 322 patients, more than two months ahead of the company's initial guidance. Tivozanib, the company's lead program, is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor receptors. A pre-planned futility analysis of the TIVO-3 trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The 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 a first and third line treatment for RCC. The TIVO-3 trial is enrolling patients with recurrent RCC who have failed at least two prior regimens, including VEGFR-TKI therapy. Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability.

AVEO Aveo Pharmaceuticals
$0.74

-0.0239 (-3.13%)

01/05/17
PIPR
01/05/17
NO CHANGE
Target $1.75
PIPR
Overweight
Ophthotech termination of AMD pact with AVEO not a surprise, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff said that following the Phase 3 Fovista miss last month it is "not a surprise" that Ophthotech (OPHT) has terminated the tivozanib development agreement in Age-Related Macular Degeneration with AVEO Pharmaceuticals (AVEO). A CHMP approval decision for tivozanib is expected in the first half of this year, which could trigger a $4M milestone to AVEO, and The confirmatory Phase III TIVO-3 trial in 3rd-line RCC should report top-line data in 2018, noted Tenthoff, who keeps an Overweight rating and $1.75 price target on AVEO shares.
06/08/17
PIPR
06/08/17
NO CHANGE
Target $1.6
PIPR
Overweight
Safety of AVEO's tivozanib positions drug competitively, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff said the safety of tivozanib, which has been confirmed by AVEO Oncology's announcement that the TiNivo trial is progressing to its Phase 2 portion, positions the drug competitively as he believes combination regimens will ultimately dominate front-line renal cell carcinoma treatment. The analyst, who expects a potential CHMP opinion on tivozanib for front-line RCC on June 23, keeps an Overweight rating and $1.60 target on AVEO shares.

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