Aveo Pharmaceuticals has announced preliminary data from the randomised Phase 2 study comparing the combination of ficlatuzumab and gefitinib, an EGFR tyrosine kinase inhibitor (TKI), to gefitinib monotherapy in subjects with non-small cell lung cancer (NSCLC).

Ficlatuzumab is a humanised 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 exploratory Phase 2 study, 94 patients were randomised to gefitinib and ficlatuzumab / gefitinib arms, respectively, to compare ficlatuzumab and gefitinib combination therapy with gefitinib monotherapy.

The study’s primary endpoint was overall response rate (ORR) and the secondary endpoint was progression free survival (PFS).

In the intent-to-treat population, ORR was 43% for the ficlatuzumab / gefitinib combination arm, versus 40% for the gefitinib monotherapy arm, while median PFS was 5.6 months and 4.7 months for the ficlatuzumab / gefitinib combination arm and gefitinib monotherapy arm, respectively.

Tony Mok, professor and senior investigator of the Phase 2 trial at the Chinese University of Hong Kong department of clinical oncology, said patients with EGFR sensitising 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.

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"These data support a potential benefit from combining an EGFR targeted therapy with ficlatuzumab and warrant further investigation in lung cancer," Mok added.

Aveo chief medical officer William Slichenmyer said that through the company’s Human Response Platform, it was able to recognise the interplay between the EGFR and HGF / c-Met pathways.

"These biomarker insights, combined with the clinical data, support our continued development of ficlatuzumab in combination with an EGFR inhibitor. We look forward to further clinical investigation in lung cancer. In addition, we will be initiating a clinical study in head and neck cancer later this year," Slichenmyer added.