2012-09-20 16:54:28 -

By Jake King

AVEO Pharmaceuticals (NASDAQ:AVEO) announced on Thursday morning that the
company will be presenting new data for both of its lead candidates, tivozanib
and ficlatuzumab, at the European Society of Medical Oncology meeting on
September 29 and October 1. Expect some hesitancy among investors who have been
disappointed by the drugs before, but AVEO should be in the green today as the
company has guided for a third or fourth quarter New Drug Application (NDA)
submission for tivozanib, and new data is likely to support that advancement.
Tivozanib faced scrutiny earlier this quarter when Phase III data comparing
tivozanib to Nexavar (sorafenib) - Onyx Pharmaceuticals' (NASDAQ:ONXX) treatment
for renal cell carcinoma - showed that tivozanib had worse Overall Survival than
the competing drug. The FDA raised concerns over the   data, and AVEO began
conducting further analysis for the governing agency. The Overall Survival rate
in the tivozanib arm of the trial was 77%, while patients treated with sorafenib
showed 81%. Tivozanib did, however, demonstrate a stronger median Progression
Free Survival (PFS) of 11.9 months vs. 9.1 months in patients treated with
sorafenib, and even higher in treatment-naive patients. Management points to PFS
and a favorable tolerability profile as support for the product, and says that
discrepancies in the treatment methods among European trial centers may have
contributed to the OS results, which they are analyzing per the FDA's request.
Investors should see a more clear analysis at the conference, and solid guidance
for a submission timeline.

Ficlatuzumab performed poorly in a Phase II trial that reported in May, which
compared a gefitinib/ficlatuzumab combination to gefitinib as a monotherapy in
the treatment of non small-cell lung cancer (NSCLC). The trial failed to meet
its primary endpoint of improved Overall Response Rate in patients treated with
the combination therapy but did show an improvement in PFS for some subsets of
the patient population. AVEO said in a conference call in August that it is
assessing the data and will report its development plans for ficlatuzumab at a
scientific meeting later this year - ESMO.  While none of this is new
information, investors now have a timeframe for more news on the two drugs.
Ancitipation of a more rosy data set from the tivozanib trial will likely buoy
shares into ESMO, but there is still speculation on the development of
ficlatuzumab. The possibilities of both drugs ultimately rest in the hands of
the FDA, regardless of how optimistically AVEO presents the data, but it looks
as though the company will submit a tivozanib NDA sometime after the meeting.
Look for a small run-up into ESMO, which is less than two weeks away, based on
optimism for tivozanib, but trading beyond the meeting will require a closer
look at the submitted data, possibility of approval, and the company's plan for
ficlatuzumab development.

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