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news.Aveo Pharmaceuticals has reported the preliminary data from the randomized Phase 2 study comparing the combination of ficlatuzumab and gefitinib to gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC).
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Ficlatuzumab is a humanized IgG1 antibody that binds to the hepatocyte growth factor (HGF) ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway.
In the open-label two-arm randomized exploratory Phase 2 study, 94 patients were enrolled to evaluate overall response rate (ORR) and progression free survival (PFS) rate of patients treated with gefitinib and ficlatuzumab plus gefitinib.
Patients treated with ficlatuzumab/gefitinib combination arm showed ORR of 43% and median PFS of 5.6 months compared to 40% and 4.7months, respectively, for gefitinib monotherapy arm.
The Chinese University of Hong Kong Department of Clinical Oncology professor and senior investigator of the Phase 2 trial Tony Mok said patients with EGFR sensitizing mutations and low c-Met expression levels treated with the combination of ficlatuzumab and gefitinib lived twice as long without their disease progressing compared to those treated with gefitinib alone.
Aveo chief medical officer William Slichenmyer said the company will be further initiating a clinical study in head and neck cancer later this year.