Aveo Pharma flunks Phase II lung cancer study

Aveo Pharmaceuticals ($AVEO) missed the main goal of a mid-stage study in Asia of its drug ficlatuzumab for treating non-small cell lung cancer. The Cambridge, MA-based drug developer said patients treated with a combination of the drug and gefitinib didn't show a statistically significant response when compared with patients who got gefitinib alone.

Aveo's share price slid a modest 30 cents, or 2.53%, to $11.77, as of 10:30 a.m. ET Wednesday.

For Aveo, the big attraction remains the company's lead drug tivozanib, for which executives aim to request FDA approval as a treatment for aggressive kidney cancer later this year. The promise of that program has likely cushioned the blow from the failed ficlatuzumab study.

The Phase II study failed to achieve its primary endpoint of improvement in overall response rate. The overall response rate for a group of patients who took Aveo's antibody drug in combination with gefitinib, which AstraZeneca ($AZN) markets as Iressa, was 43%, just a bit higher than the 40% overall response among patients took only Iressa to combat their lung cancers. Patients on the combo treatment lived for 5.6 months without their cancer getting worse compared with 4.7 months in the gefitinib-only group, according to Aveo.

The study appears have identified a subset of patients who benefited significantly from the combo treatment, and senior investigator Dr. Tony Mok of The Chinese University of Hong Kong says the finding warrants further study. 

- here's the release
- see Reuters' coverage

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