BerGenBio reports Phase I/II data for BGB324

BerGenBio ASA (OSE:BGBIO) said daily 200 mg bemcentinib (BGB324) plus EGFR inhibitor Tarceva erlotinib met the initial efficacy endpoint in the first stage of the Phase II portion of the Phase I/II BGBC004 trial to treat stage IIIb or IV EGFR-mutant non-small cell lung cancer (NSCLC). That endpoint required at least one of nine patients achieve stable disease beyond three months (4 cycles) of treatment with bemcentinib plus Tarceva. Two patients achieved the endpoint, while a third showed stable disease for at least six weeks. All patients in the first phase had progressed on prior therapy with an approved EGFR inhibitor and were negative for the T790M mutation.

BerGenBio is now enrolling an additional 14 patients to receive daily 200 mg bemcentinib plus Tarceva as first-line therapy in the second stage of the Phase II portion to assess bemcentinib's ability to prevent resistance to Tarceva. The study is assessing the safety, pharmacodynamics and clinical activity of bemcentinib...