BerGenBio ASA will present updated preliminary survival data from the ongoing Phase II study of bemcentinib (BGBC003) in combination with low dose cytarabine (LDAC) in elderly relapsed Acute Myeloid Leukaemia (AML) patients at the European Haematology Association (EHA) 2021 Virtual Meeting, taking place from 9 -17 June 2021. An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis. The data indicate that the combination of bemcentinib, a once-daily oral AXL-inhibitor and LDAC is efficacious and well tolerated in the elderly and unfit relapsed AML population. Durable responses were observed in the relapsed AML setting, with an overall response rate of 31% (5/16) and median overall survival of 13.3 months, currently still immature and potentially subject to change. In a subset of eleven relapsed AML patients, who received two or more cycles of the combination, an increased clinical benefit was demonstrated; a CR/CRi rate of 36% (4/11) was observed, coupled with encouraging overall survival to date (median OS not reached at >16 months) with several subjects continuing on the study. In contrast, historic controls of LDAC monotherapy suggest CR/CRi rates of 13-17% with median survival rates of 4.1-5.6 months, as reported by Sarkozy etal. (2015) and Wei et al. (2020). An in-depth translational research program to identify predictive molecular and biological factors associated with response is ongoing. Ongoing dialogue continues with the FDA and EMA regulatory agencies to align on a pathway for a pivotal registration trial for the combination of bemcentinib and LDAC in relapsed elderly AML patients unfit for intensive chemotherapy.