PropThink: Tivozanib and Ficlatuzumab Uncertainty to be Partially Resolved at ESMO

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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