MDS Patients at ASH

BERGEN, Norway, Nov. 3, 2018 /PRNewswire/ --

43% CR/CRi/CRp rate with bemcentinib monotherapy reported in AXL biomarker positive R/R AML/MDS patients (6 out of 14)
Phase II trial continues in combination with chemotherapeutics in first line AML
Bemcentinib with decitabine cohort has completed recruitment, data will be submitted for presentation at upcoming medical congress

BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications, today announced that it presented a comprehensive analysis of monotherapy data from its BGBC003 clinical trial (NCT02488408) with selective AXL inhibitor bemcentinib in patients with relapsed/refractory Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS).

In a poster presentation at the 60th American Society of Hematology Annual Meeting (ASH) in San Diego entitled: "Comprehensive Analysis of the Dose Escalation, Expansion and Correlates in the Ph I/II Trial BGBC003 with the Selective Oral AXL Inhibitor Bemcentinib (BGB324) in Relapsed/Refractory AML and MDS", Professor Sonja Loges, attending physician at the University Hospital in Hamburg-Eppendorf and lead investigator of the BGBC003 trial, detailed the following:

14 of 26 (54%) of patients found to be AXL positive (denoted by low serum AXL, sAXL, levels at start of treatment)
Response rate of 43% CR/Cri/CRp to bemcentinib monotherapy in AXL positive patients and 22% overall.
Mild and manageable side effect profile with a low incidence of Grade 3/4 events and low incidence of haematological toxicity.

Furthermore, the Company announces that enrolment is complete into the phase II combination cohort of bemcentinib and decitabine in first line AML. Analysis of the activity of the combination will be submitted for presentation at a future medical congress.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "I am very encouraged by the data presented today, we are consistently seeing AXL positive patients report a superior response to bemcentinib therapy alone or in combination with standard of care therapy. The value of our biomarkers to identify patients most likely to benefit from bemcentinib is tremendous. Based on our clinical data, more than 50% of AML/MDS patients are AXL positive, of which 43% reported complete response within the first few weeks of starting bemcentinib monotherapy treatment. Bemcentinib is very well tolerated by patients as a single agent and in combination with other drugs, which is an important feature supporting bemcentinib's broad utility. We are making excellent progress recruiting the chemotherapy combination arms of this study and look forward to reporting the data from these patients in the coming months".