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.
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