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Bemcentinib is a first-in-class, potent, small selective molecule inhibitor of AXL, which is a surface membrane protein overexpressed in up to half of acute myeloid leukemia (AML) cases.1 It has exhibited anti-leukemic activity as monotherapy in patients with relapsed/refractory (R/R) AML.2
A phase I dose escalation and expansion study (NCT02488408) of bemcentinib monotherapy has previously been completed which identified the recommended phase II dose (RP2D) to be 200mg orally, daily (po/d).2 The phase I portion also aimed to identify anti-leukemic activity.
The phase II portion was designed to investigate the safety and efficacy of bemcentinib in combination with low dose cytarabine (LDAC) or decitabine when administered to patients with R/R AML who were unfit for intensive chemotherapy. Results from the phase II portion of the study (BGBC003) were presented during a poster sessions at the American Society of Clinical Oncology (ASCO) meeting, and at the European Hematology Association (EHA) annual meeting, by Sonja Loges and colleagues. Secondary objectives included overall survival (OS) and exploratory biomarker analysis.2,3
Dosing schedule was as below:2
Treatment-related adverse events (TRAEs):
At a data cut-off of March 2019:
Median progression-free survival (PFS) in the five patients with durable CRi or SD was reported to be 5 months (3.5–7.7) at the ASCO meeting.2
The authors concluded that bemcentinib, in combination with LDAC, provided durable responses in patients with de novo and R/R AML, as well as in elderly patients and those with poor-risk disease.3 Treatment with bemcentinib with decitabine achieved fewer responses, and those that were observed occurred later.2
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