BerGenBio ASA announced that the first efficacy endpoint has been met in its phase II clinical trial evaluating 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 EGFR inhibitor (ClinicalTrials.gov Identifier: NCT02424617). The trial (known as BGBC004) is designed to test the hypothesis that selective AXL inhibition with the once-daily oral small molecule bemcentinib may reverse and prevent resistance to erlotinib, a therapy targeting constitutively active epidermal growth factor receptor (EGFR) signalling - a pathway frequently upregulated in cancers, particularly NSCLC. The trial is enrolling patients with activating EGFR mutations across three settings: Arm A 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. This arm is completed and a recommended phase II dose has been established. 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. This arm has successfully completed its first stage (announced today). The initial endpoints of the first stage of Arm B were exceeded. An overall disease control rate of 33% was reported in patients who completed at least one cycle of treatment (n=9) thus providing preliminary proof of concept that bemcentinib can restore sensitivity to EGFR targeted therapy in some patients. Arm C is designed to evaluate the ability of bemcentinib to prevent acquired resistance to EGFR targeted therapy when given in combination with erlotinib first line. This arm is recruiting patients with interim results expected mid-2018.