Norway-based BerGenBio has met the first efficacy endpoint in the phase II clinical trial assessing BGB324 (bemcentinib), a selective AXL inhibitor, in combination with erlotinib in patients with advanced non-small cell lung cancer (NSCLC) who have progressed on an approved epidermal growth factor receptor (EGFR) inhibitor, it was reported yesterday.

The trial is called BGBC004 and is designed to test the hypothesis that selective AXL inhibition with the once-daily oral small molecule bemcentinib is likely to reverse and prevent resistance to erlotinib, a therapy targeting constitutively active EGFR, indicating a pathway frequently upregulated in cancers, particularly NSCLC.

The trial is enrolling patients with activating EGFR mutations across three settings that include Arm A that is designed to determine the daily dose of bemcentinib that can be safely administered in combination with erlotinib in patients who have received prior erlotinib therapy, Arm B follows a Simon-like two-stage design evaluating the ability of bemcentinib to restore sensitivity to EGFR targeted therapy when given in combination with erlotinib in patients who have progressed on prior therapy with an approved EGFR inhibitor and that are negative for the T790M mutation, and Arm C designed to evaluate the ability of bemcentinib to prevent acquired resistance to EGFR targeted therapy when given in combination with erlotinib first line. BerGenBio expects to present clinical data from this study at an international cancer conference during 2018.