Tivozanib and Ficlatuzumab Uncertainty to be Partially Resolved at ESMO

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.