16 April 2018 - - Bergen, Norway-based clinical-stage biopharmaceutical company BerGenBio ASA (OSE: BGBIO) has completed enrollment of the planned 22 patients into the first stage of its Phase II clinical trial evaluating bemcentinib, its investigational oral selective AXL inhibitor, in combination with the Kenilworth, New Jersey-based global healthcare solutions provider Merck (NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab) as a potential new treatment regimen for advanced lung cancer, the company said.
The Phase II trial (BGBC008) follows a two-stage design: it is an open label, multi-centre study of bemcentinib in combination with Keytruda in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose disease is progressing. Up to 48 patients in total will be included in the study (NCT03184571).
The trial is designed to evaluate the anti-tumour activity, objective response rate and safety of the combination, and to correlate the patient response with biomarker status (including AXL kinase and PD-L1 expression). In parallel, companion diagnostics using these and other biomarkers are being developed for the identification of patients predicted to be most suitable for treatment with the bemcentinib / Keytruda combination.
The trial is being conducted under a clinical collaboration with Merck and Co. through a subsidiary, and is taking place at more than 12 clinical sites in the US, UK, Norway and Spain.
Bemcentinib (BGB324), is a selective, potent and orally bio-available small molecule AXL inhibitor in four company sponsored Phase II clinical trials in major cancer indications.
BerGenBio is developing a pipeline of first-in-class AXL kinase inhibitors as a potential cornerstone of combination cancer therapy in NSCLC, AML/MDS, TNBC, and melanoma. The company is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with bemcentinib.