Abstract
Abstract Background Upregulation of the receptor tyrosine kinase Axl has been linked with both a reduced response to immune checkpoint blockade as well as the development of therapy resistance to BRAF directed therapies in melanoma. Bemcentinib is a first-in-class orally bioavailable selective inhibitor of Axl which is currently being explored in several phase II clinical trials. BGBIL006 (NCT02872259) is an open label phase Ib/II trial designed to explore whether combinations with bemcentinib improves ORR and duration of response compared to standard of care therapies in patient (pts) with metastatic melanoma (MM). Trial design Patients are randomized 2:1 to receive D/T or pembro +/- bemcentinib, respectively, based on mutation status and tumour load. BRAF positive pts are allowed to switch D/T with pembrolizumab and vice versa upon progression. Tumour responses are assessed per investigator using RECIST v1.1. Plasma protein biomarker levels are measured using the DiscoveryMap v3.3 panel (Myriad RBM) in pts pre-dose and at C2D1. In June 2019, a formal interim analysis of clinical safety and efficacy data will be performed when at least 20 randomised patients have completed up to 12 cycles of treatment. Currently, 50 pts (92 planned) have been enrolled in the trial. Tolerability of the bemcentinib RP2D (200 mg daily) in combination with either D/T or pembro, and AE profiles for either therapeutic approach alone will be reported. Protein biomarkers candidates predictive of pt benefit following treatment and pre/post treatment changes of soluble proteins will be presented. Preliminary efficacy outcome data and safety data from the first formal preplanned interim analysis will be presented together with the recommendations from the Data Monitoring Committee. Clinical trial identification NCT02872259. Legal entity responsible for the study The authors. Funding Research Council Norway. Disclosure O. Straume: Travel / Accommodation / Expenses: BerGenBio. J.B. Lorens: Shareholder / Stockholder / Stock options: BerGenBio ASA. G. Gausdal: Full / Part-time employment: BerGenBio ASA. All other authors have declared no conflicts of interest.
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