BerGenBio Presents Preliminary Phase II Clinical Data at EHA 24: Bemcentinib in Combination With Low Dose Chemotherapy Yields Durable Responses in AML Patients Unfit for Intensive Chemotherapy
- Two posters to be presented at the 2019 annual congress of the
European Hematology Association on 14th June - Phase II trial evaluating bemcentinib in combination with low-intensity chemotherapy in elderly acute myeloid leukaemia (AML) patients unfit for intensive chemotherapy shows significant efficacy
- Preliminary responses reported in 6/14 (43%) patients, with CR/CRi in 4/14 (29%) patients; this is substantially higher than previously observed/historical benchmarks in single-agent cytarabine (low-dose chemotherapy)
- Median relapse-free survival 7.9 months in CR/CRi patients (data not mature)
- A second biomarker poster presented by
Prof. Gjertsen , University Bergen, shows pharmacodynamic effects of bemcentinib on AML patients blast cell signal at just 4 hours post-dosing of bemcentinib
/PRNewswire/ --
In total, 16 patients were enrolled into the trial. Among the 14 patients evaluable for efficacy, 6 responses have been reported; 4 patients achieved complete remission / complete remission with incomplete hematologic recovery (CR/CRi) and 2 patients achieved partial remission (PR). Five of the six responses occurred among elderly AML patients (>75 years). Furthermore, two patients achieved durable stable disease for more than 3 months. The relapse-free survival rate for patients with CR/CRi is 7.9 months (range: 0.7 to 9.6 months) and continues to mature. The combination treatment of bemcentinib and LDAC was overall well-tolerated; the most common adverse events (>15% of patients) included anaemia, neutropenia and diarrhoea. Soluble protein (e.g. sAXL) and gene expression biomarker data is still maturing and will be reported in due course. A second biomarker poster from
Professor Bjørn
The posters presented at EHA will be made available at www.bergenbio.com in the Investors / Presentations section to coincide with the following conference sessions:
Friday 14 June, 17:30 - 19:00 Central European Time
The Combination of bemcentinib, a novel, oral, selective AXL-Inhibitor and Low-Dose Cytarabine yields Durable Responses in AML patients Unfit for Intensive Chemotherapy
- Author: Sonja Loges et al.
- Abstract: PF259
- Location: Poster area
Saturday 15 June, 17:30 - 19:00 Central European Time
Single Cell Signaling Pharmacodynamics in a Phase 1b Clinical Trial of the AXL inhibitor bemcentinib in Acute Myeloid Leukemia and Myelodysplastic Syndrome
- Author: Monica Hellesøy et al.
- Abstract: PS999
- Location: Poster area
About AML and the BGBC003 Trial
Acute myeloid leukaemia (AML) is a rapidly progressing blood cancer. AML is the most common form of acute leukaemia in adults, where malignant AML blasts interfere with the normal functioning of the bone marrow leading to a multitude of complications like anaemia, infections and bleeding. AML is diagnosed in over 20,000 patients in the US annually and is rapidly lethal if left untreated. Successful treatment typically requires intensive therapy or bone marrow transplantation, and relapse and resistance are common. Consequently, there is an urgent need for effective novel therapies in relapsed/refractory patients, particularly those that are ineligible for intensive therapy or bone marrow transplant.
The BGBC003 trial is a phase Ib/II multi-centre open label study of bemcentinib in combination with cytarabine (part B2) and decitabine (part B3) in patients with AML who are unsuitable for intensive chemotherapy as a result of advanced age or existing-co-morbidities. Up to 28 patients will be enrolled at centres in the US,
For more information please access trial NCT02488408 at www.clinicaltrials.gov.
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body's immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.
About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.
About
Forward looking statements
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.
Contacts:
+47-917-86-304
[email protected]
+47-917-86-513
International Media Relations:
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+44-20-3700-5700
Media Relations in
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