BerGenBio’s AXL inhibitor clears early efficacy test in NSCLC

BerGenBio has brought cancer drug BGB324 through an early efficacy assessment. The study linked the AXL inhibitor to a 33% disease control rate in non-small cell lung cancer (NSCLC) patients who had previously progressed following treatment with an EGFR inhibitor.

Bergen, Norway-based BerGenBio is developing BGB324, also known as bemcentinib, in the belief that its effect on AXL can reverse and prevent resistance to EGFR drugs such as Genentech’s Tarceva. The generation of clinical data to back up that belief would position the oral small molecule as a way to prolong the efficacy of Tarceva and other drugs that act EGFR signalling.

BerGenBio now has a glimmer of clinical data to suggest it may be on the right track. The drug chalked up a disease control rate of 33% in the nine NSCLC patients who completed at least one cycle of treatment. The patients had previously progressed following treatment with an EGFR inhibitor. All of the patients were negative for the T790M mutation.

“Two patients in Arm B continue on study and are experiencing sustained disease control and one patient in Arm A is approaching their two-year anniversary on bemcentinib in combination with erlotinib and is asymptomatic,” BerGenBio CEO Richard Godfrey said in a statement.

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Limited conclusions can be drawn from that level of effect in that few patients. But BerGenBio sees the result as good enough to warrant starting enrollment in the next arm of the study and as supporting its confidence that BGB324 can restore sensitivity to EGFR targeted therapies, at least in some patients.

The third cohort now enrolling in the trial will receive BGB324 in combination with Tarceva as a first-line treatment. If BGB324 can improve the responses of those patients to Tarceva, it will suggest the drug may become part of the arsenal of drugs doctors use to treat people when they are first diagnosed with NSCLC. BerGenBio expects to have interim data from the arm by the middle of 2018.

The current and planned data drops are part of the roadmap BerGenBio sketched out when it pulled off a $49 million IPO in Norway last year.