BerGenBio has met the initial efficacy endpoint in its Phase II trial of BGB324 (bemcentinib) selective AXL inhibitor in combination with erlotinib in patients with advanced non-small cell lung cancer (NSCLC).

The BGBC004 trial is designed to investigate the hypothesis that selective AXL inhibition with once-daily oral small molecule bemcentinib may reverse and prevent resistance to erlotinib, a therapy targeting constitutively active EGFR signalling.

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The trial enrols patients who have progressed on an approved epidermal growth factor receptor (EGFR) inhibitor, with activating EGFR mutations across three arms, A, B, and C.

Arm A of the trial seeks to determine the daily dose of bemcentinib that can be safely given in combination with erlotinib to patients who have received prior erlotinib therapy. The arm is finished and recommendation for a Phase II dose has been set-up.

“The trial’s Arm C is expected to examine the ability of bemcentinib to prevent acquired resistance to EGFR targeted therapy when given in combination with erlotinib first-line.”

Arm B features a Simon-like two-stage design to assess 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 are negative for the T790M mutation.

This arm has been able to meet the newly announced endpoint that demonstrates an overall disease control rate of 33% in patients who completed at least one cycle of treatment.

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The result offers a preliminary proof of concept that bemcentinib can restore sensitivity to EGFR targeted therapy in some patients.

The trial’s Arm C is expected to examine the ability of bemcentinib to prevent acquired resistance to EGFR targeted therapy when given in combination with erlotinib first-line.

Recruitment in this arm is still going on, with interim results expected to be released during mid-2018.