OSLO, Norway, June 14, 2019 /PRNewswire/ --
- 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/ -- BerGenBio ASA (OSE:BGBIO) today presents data
showing significant efficacy in a Phase II clinical trial (BGBC003,
NCT02488408) evaluating bemcentinib, a first-in-class selective
oral AXL inhibitor, in combination with low-dose cytarabine (LDAC)
as a potential new treatment regimen for AML patients unfit for
intensive therapy. The data will be presented by Professor Bjørn
Tore Gjertsen MD PhD, Haukeland
University Hospital and University of
Bergen, at the 2019 annual congress of the European
Hematology Association (EHA24), in Amsterdam, The Netherlands, Friday, June 14, 2019.
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 Prof. Gjertsen's group,
to be presented on June 15th,
examined the effect of bemcentinib monotherapy from a phase
1b/2 clinical trial on patient AML
cell signal transduction using mass cytometry. The high-dimensional
single cell-level signalling analysis of AML blasts from 6
evaluable patients revealed significant effects already at 4 hours
post-dosing of bemcentinib.
Professor Bjørn Tore Gjertsen
commented: "These early results are encouraging, especially
among less fit AML patients with comparatively poor prognosis.
Bemcentinib in combination with LDAC resulted in a substantially
higher ORR than expected for single-agent cytarabine and clearly
warrant further investigation of bemcentinib in an expansion cohort
of AML patients unfit for intensive chemotherapy. Our signal
cell-level biomarker analysis of AML blasts from patients indicates
a substantial effect on cell signalling and represents a potential
new biomarker strategy."
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "There are
currently limited treatment options for AML patients unable to
tolerate intensive chemotherapy, particularly those with relapsed
and refractory disease. These promising preliminary data with
bemcentinib in combination with low-dose cytarabine, reinforce data
we recently at presented at ASCO, and suggests that the addition of
our selective AXL inhibitor can substantially improve AML patient
outcomes. I am particularly encouraged by the high response rate
observed in all patient groups studied, the extended duration of
responses seen, which is still maturing, and how well the
combination therapy was tolerated. We are still waiting on much of
our biomarker data before we can report that and are very excited
by cell signalling data presented by our collaborators at the
University of Bergen. We will expand
this study to include more patients and report more complete data
in the coming months.¨
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, Norway,
Germany and Italy.
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 BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused
on developing transformative drugs targeting AXL as a potential
cornerstone of therapy for aggressive diseases, including
immune-evasive, therapy resistant cancers. The company's
proprietary lead candidate, bemcentinib, is a potentially
first-in-class selective AXL inhibitor in a broad phase II oncology
clinical development programme focused on combination and single
agent therapy in lung cancer and leukaemia. A first-in-class
functional blocking AXL antibody (BGB149) and an AXL-ADC (ADCT-601)
are undergoing phase I clinical testing. In parallel, BerGenBio is
developing a companion diagnostic test to identify those patient
populations most likely to benefit from bemcentinib: this is
expected to facilitate more efficient registration trials
supporting a precision medicine-based commercialisation
strategy.
BerGenBio is based in Bergen,
Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo
Stock Exchange (ticker: BGBIO). www.bergenbio.com
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:
Richard Godfrey CEO, BerGenBio ASA
+47-917-86-304
Rune Skeie, CFO, BerGenBio
ASA
rune.skeie@bergenbio.com
+47-917-86-513
International Media Relations:
Mary-Jane Elliott,
Chris Welsh, Jessica Hodgson, Nicholas Brown, Carina
Jurs
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44-20-3700-5700
Media Relations in Norway:
Jan Petter Stiff, Crux
Advisers
stiff@crux.no
+47-995-13-891
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