Ficlatuzumab: Phase II data

Data from 188 patients with previously untreated NSCLC in the Phase II portion of an open-label, Asian Phase Ib/II trial showed that first-line treatment with ficlatuzumab plus gefitinib missed the primary endpoint of improving ORR vs. gefitinib alone (43% vs. 40%, p-value not disclosed). Ficlatuzumab plus gefitinib also missed the secondary endpoint of median PFS vs. gefitinib alone (5.6 vs. 4.7 months, p-value not disclosed).

In a subgroup of patients with EGFR-sensitizing mutations and low levels of c-Met receptor tyrosine kinase expression (n=19), ficlatuzumab plus gefitinib non-significantly improved ORR (70% vs. 44%) and median PFS vs. gefitinib alone (11 vs. 5.5 months). In a subgroup of patients with EGFR-sensitizing mutations and high levels of c-Met receptor tyrosine kinase expression (n=60), ficlatuzumab plus gefitinib led to an ORR of 52% vs. 63% for gefitinib alone, with no difference in median PFS between treatment groups (9.2 months for both). In a subgroup of patients with high levels of c-Met receptor tyrosine kinase expression without EGFR-sensitizing mutations (n=27), ficlatuzumab plus gefitinib led to an ORR of 27% vs. 13% for gefitinib alone, with no difference in median PFS between treatment groups (1.8 months for both). There were also no differences between treatment groups in patients with low levels of c-Met receptor tyrosine kinase expression without EGFR-sensitizing mutations (n=22). ...