AVEO Pharmaceuticals announced preliminary data from the exploratory, randomized Phase 2 study comparing the combination of ficlatuzumab and gefitinib (Iressa; AstraZeneca Pharmaceuticals), to gefitinib monotherapy in previously untreated Asian subjects with non-small cell lung cancer (NSCLC), a population with a high prevalence of EGFR sensitizing mutations (SM+). In this study, encouraging signals of activity were observed in unique subsets of patients based on EGFR mutation status and c-Met expression level.
The open-label, two-arm, randomized exploratory Phase 2 study was designed to compare the combination of ficlatuzumab and gefitinib vs. gefitinib monotherapy, in clinically selected Asian subjects with previously untreated advanced NSCLC who have a high likelihood of harboring activating EGFR mutations. Ninety-four patients were randomized to gefitinib and ficlatuzumab/gefitinib arms, respectively; 144 tumor tissue samples were available for biomarker analysis. Subjects who demonstrated disease control (complete response, partial response, or stable disease for ≥12 weeks) in the gefitinib alone arm were eligible to cross-over upon progression to a combination of gefitinib and ficlatuzumab to assess whether acquired resistance to gefitinib can be overcome with the addition of ficlatuzumab.
The primary endpoint of the study was overall response rate (ORR), and progression free survival (PFS) was a secondary endpoint. Preliminary results in the intent-to-treat (ITT) population (n=94 each arm) showed a trend favoring the ficlatuzumab/gefitinib combination. In the ITT population, ORR was 43% for the ficlatuzumab/gefitinib combination arm versus 40% for the gefitinib monotherapy arm, and median PFS was 5.6 months vs. 4.7 months for the ficlatuzumab/gefitinib combination arm vs. the gefitinib monotherapy arm, respectively, favoring the combination arm.
Ficlatuzumab is a humanized IgG1 antibody that binds to the HGF ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway. Gefitinib is a tyrosine kinase inhibitor.
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