Norway-based BerGenBio has completed enrolment of the planned 28 patients into the first stage of its Phase II clinical trial assessing its investigational oral selective AXL inhibitor, bemcentinib (BGB324), in combination with the Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), intended for the potential new treatment regimen for advanced breast cancer, it was reported yesterday.

The Phase II trial, named BGBC007 follows a two-stage design. It is an open label, multi-centre study of bemcentinib in combination with KEYTRUDA in patients with earlier treated, locally advanced and unresectable or metastatic triple negative breast cancer or triple negative inflammatory breast cancer. Up to 56 patients in total will be included in the study (NCT03184558).

The trial is designed to assess efficacy and safety of the combination, and to correlate the patient response with biomarker status (AXL kinase and PD-L1 expression). It was started in October 2017 and is being conducted under a clinical collaboration with Merck & Co Inc, Kenilworth, New Jersey, USA, through a subsidiary, and is taking place at more than 16 clinical sites in the US and Europe.

Interim results are expected mid-year 2018.