Struggling AVEO Oncology Quietly Discontinues Phase II Ficlatuzumab Study
September 12, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRDIGE, Mass. – Shares of Aveo Pharmaceuticals are falling after the company announced in a federal filing it was terminating its Phase II study of ficlatuzumab, an HGF inhibitory antibody, combined with the cancer drug Tarceva as a first-line treatment for EGFR-mutated non-small cell lung cancer patients.
In the 8-K filing filed Sept. 9, Aveo said a blinded interim analysis of the Focal trial found patients who were positive for both VSP and EGFR mutations of NSCLC “experienced materially higher discontinuation rates than observed in both the general ITT population and retrospective exploratory subgroup population.” As a result, Aveo said the observation “significantly compromised the feasibility of the trial” and discontinued the study.
The company said the Phase II Focal trial was designed to confirm results from a “retrospective exploratory analysis” of a randomized Phase II clinical trial that compared the combination of ficlatuzumab and AstraZeneca ’s Iressa (gefitinib), to a gefitinib monotherapy in previously untreated Asian patients with advanced NSCLC who tested positive for both EGFR mutation and VSP. The previous study, P06162, demonstrated a statistically significant improvement in overall survival (OS) and progression free survival (PFS) for patients in the gefitinib plus ficlatuzumab arm that were classified as VSP, the company said in its federal filing.
The discontinuation of the study is a blow to the beleaguered Aveo, which was slapped with a $4 million fine earlier this year to settle complaints the company misled investors about concerns raised by U.S. regulatory bodies about the company’s kidney cancer drug, Tivozanib. The U.S. Securities and Exchange Commission said Aveo concealed investors from concerns raised by the U.S. Food and Drug Administration about the drug. Tivozanib is an oral selective inhibitor of vascular endothelial growth factor (VEGH).
“We allege that AVEO and its executives hid from investors the reality of their communications with the FDA on Tivozanib while suggesting they had identified a simpler route to FDA approval,” Paul Levenson, director of the SEC’s Boston Regional Office, said in a statement. “Companies must be forthcoming about their communications with regulators so investors can make informed investment decisions while knowing what challenges may lay ahead.”
Over the course of 2015, Aveo has undergone a streamlining of its organization, which saw a shift in executive officers as well as the termination of approximately two-thirds of its workforce. The company also moved to a smaller headquarters. The restructuring occurred, in part, due to its pipeline, including AV-380, a first-in-class GDF-15 inhibitor, having gone past the research stage.