BerGenBio ASA Completes Recruitment of Phase II AML Study ((BGBC003)
September 07, 2021 at 01:21 pm EDT
BerGenBio ASA announces the completion of patient recruitment into BGBC003 (ClinicalTrials.gov ID: NCT02488408), a Phase Ib/II multicenter open-label study of bemcentinib as a single agent and in combination with cytarabine or decitabine in patients with Acute Myeloid Leukemia (AML) or as a single agent in patients with myelodysplastic syndrome (MDS). BerGenBio has recruited a total of 86 patients in cohort B, with between 14 and 18 patients in each of the cohorts B1-B4 and 20 patients in cohort B5, as per protocol. In June 2021, the latest study data was published at the European Haematology Association (EHA) Meeting, which indicated that the combination of bemcentinib and low dose cytarabine (LDAC) is efficacious and well tolerated in relapsed elderly AML patients unfit for intensive chemotherapy, with an overall response rate of 31% (5/16) and median overall survival of 13.3 months. The encouraging preliminary survival data reported showed that the addition of bemcentinib more than doubled the historic survival rates seen with standard of care treatment in this patient population. An in-depth translational research program to identify predictive molecular and biological factors associated with response is ongoing. Dialogue continues with the regulatory agencies in the US and Europe to align on a pathway for a pivotal registration trial for the bemcentinib/LDAC combination in relapsed elderly AML patients unfit for intensive chemotherapy.