On September 12, 2016 AVEO Pharmaceuticals, Inc. ("AVEO") reported discontinuation of the FOCAL study, a Phase 2, global, randomized, double-blind, placebo controlled clinical study, evaluating ficlatuzumab, AVEO’s HGF inhibitory antibody, in combination with erlotinib (Tarceva), an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) in first line, VeriStrat (BDX 004) Poor (VSP), EGFR-mutated NSCLC patients (Filing, 8-K, AVEO, SEP 9, 2016, View Source [SID:SID1234515089]). VeriStrat is a proprietary biomarker test developed by Biodesix to select patients for entry into the trial.
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The FOCAL study was prospectively designed to confirm results from a retrospective exploratory analysis of a randomized Phase 2 clinical trial ("Study P06162") comparing the combination of ficlatuzumab and gefitinib (IRESSA), an EGFR TKI therapy, to gefitinib monotherapy in previously untreated Asian patients with advanced NSCLC who had tested positive for both EGFR mutation and VSP. 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.
After experiencing slower than expected enrollment, a blinded interim analysis of the FOCAL study was conducted and found that patients who were positive for both VSP and EGFR mutations, who were known to be selected for poor prognosis, experienced materially higher discontinuation rates than observed in both the general ITT population and retrospective exploratory subgroup population of Study P06162, which was the basis for the FOCAL study design. This observation significantly compromised the feasibility of the trial. The parties have mutually agreed to discontinue the study. The parties intend to further discuss the details for the discontinuation of the study and future development of ficlatuzumab.