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AVEO

Aveo Pharmaceuticals

$0.62

0.0092 (1.51%)

12:42
02/17/19
02/17
12:42
02/17/19
12:42

Aveo Pharmaceuticals presents TIVO-3 trial topline results

Aveo Oncology announced the presentation of data from the Phase 3 TIVO-3 study of tivozanib versus sorafenib in refractory advanced or metastatic renal cell carcinoma. The data were presented at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium held February 14-16, 2019 in San Francisco. The TIVO-3 trial is a Phase 3 randomized, controlled, multi-center, open-label study designed to compare tivozanib to sorafenib in 350 subjects with highly refractory advanced or metastatic renal cell carcinoma. The trial met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival. Tivozanib demonstrated a 44% improvement in median PFS and 26% reduction in the risk of progression or death. Median PFS was 5.6 months for tivozanib compared to 3.9 months for sorafenib. The TIVO-3 trial enrolled patients with RCC who have failed at least two prior regimens. Among these, approximately 26% of patients received checkpoint inhibitor therapy in earlier lines of treatment. PFS for tivozanib was longer than sorafenib both in patients who received prior CPI therapy and those who received two prior VEGF TKI therapies. Patients who received prior CPI therapy had a median PFS of 7.3 months with tivozanib and 5.1 months with sorafenib. One- and two-year PFS in patients who received tivozanib following CPI therapy was 35% and 25%, respectively, and 4% and n/a for patients receiving sorafenib following CPI therapy at those respective time periods. The secondary endpoint of overall response rate for patients receiving tivozanib was 18% compared to 8% for patients receiving sorafenib. Median duration of response in patients receiving tivozanib was not reached and was 5.7 months for patients receiving sorafenib. DOR probability at 1 year was 71% and 46% for tivozanib and sorafenib, respectively, and 55% and 0% at two years. The analysis of the secondary endpoint of overall survival was not mature at the time of the final PFS analysis, and currently reflects about 50% of potential OS events. As previously disclosed, the updated preliminary OS analysis conducted at an October 4, 2018 data cutoff date, which included additional patients previously lost to follow-up, showed a non-statistically significant difference in OS favoring sorafenib. The company intends to conduct an additional interim OS analysis in August 2019, the results of which are expected to be reported in the fourth quarter of 2019. Tivozanib was generally well-tolerated, with grade 3 or higher adverse events consistent with those observed in previous tivozanib trials. Infrequent but severe adverse events reported in greater number in the tivozanib arm were thrombotic events similar to those observed in previous tivozanib studies. The most common adverse event in patients receiving tivozanib was hypertension, an adverse event known to reflect effective VEGF pathway inhibition.

AVEO Aveo Pharmaceuticals
$0.62

0.0092 (1.51%)

02/04/19
02/04/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Aveo Pharmaceuticals (AVEO) downgraded to Neutral from Buy at B. Riley FBR with analyst Harshita Polishetty saying she sees a financing overhang after the FDA recommended against the filing of the company's tivozanib new drug application. 2. BHP Billiton (BHP) downgraded to Underweight from Neutral at JPMorgan while Rio Tinto (RIO) was downgraded to Neutral from Overweight at. 3. SAP (SAP) downgraded to Neutral from Buy at BofA/Merrill. 4. MacroGenics (MGNX) downgraded to Sell from Neutral at Citi with analyst Yigal Nochomovitz saying his re-examination of the prior Phase 1 data underpinning the ongoing Phase 3 SOPHIA trial has led him to revise his base case expectation to a failure for the trial. 5. Okta (OKTA) downgraded to Sector Weight from Overweight at KeyBanc with analyst Rob Owens saying that while the Street clearly anticipates meaningful upside to expectations, he believes many of the upside scenarios render shares fairly valued at current levels. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
02/04/19
RILY
02/04/19
DOWNGRADE
Target $1
RILY
Neutral
Aveo Pharmaceuticals downgraded to Neutral from Buy at B. Riley FBR
B. Riley FBR analyst Harshita Polishetty downgraded Aveo Pharmaceuticals to Neutral and lowered her price target for the shares to $1 from $5. The analyst sees a financing overhang after the FDA recommended against the filing of the company's tivozanib new drug application.
02/01/19
HCWC
02/01/19
DOWNGRADE
Target $1
HCWC
Neutral
Aveo Pharmaceuticals downgraded to Neutral from Buy at H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth downgraded Aveo Pharmaceuticals to Neutral and cut his price target for the shares to $1 from $9. The company yesterday announced that the FDA has recommended against the filing of tivozanib new drug application, citing the drug's potential detriment to overall survival seen in the results of the TIVO-3 study, Ramakanth tells investors in a research note. This development adds "significant uncertainty" to the future of tivozanib in the U.S. as a monotherapy, says the analyst.
01/31/19
PIPR
01/31/19
NO CHANGE
Target $3
PIPR
Overweight
Aveo price target lowered to $3 on TIVO-3 update at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff lowered his price target for Aveo Pharmaceuticals to $3 from $5 given that the company now intends to report TIVO-3 overall survival data prior to filing the NDA for tivozanib, which could slip from 1H19 into Q4 of 2019 or early 2020. The analyst notes that the FDA stated preliminary OS data from the Phase III TIVO-3 trial in 3-line renal cell carcinoma did not remove concerns related to OS outlined in the 2013 Complete Response Letter. In addition, Aveo Pharmaceuticals updated that the OS hazard ratio worsened to 1.12 from 1.06 following inclusion of additional patients previously lost to follow up, he notes, adding that while worse, this HR is based on more patients, but still as of the October 4th cutoff. Tenthoff reiterates an Overweight rating on the shares.

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