CHICAGO, June 3, 2019 /PRNewswire/ --
- Phase II trial evaluating bemcentinib in combination with
low-intensity chemotherapy in elderly AML patients unfit for
intensive therapy shows promising efficacy
- 6 out of 13 (46%) patients receiving LDAC combination achieved
an Overall Response Rate (ORR) of 46%
- 3 out of 12 evaluable patients receiving decitabine combination
achieved an ORR of 25%
- ORR significantly higher than previously observed/historical
benchmarks in single-agent cytarabine
BerGenBio ASA (OSE:BGBIO) today presents data showing
significant efficacy in Phase II clinical trials (BGBC003,
NCT02488408) evaluating bemcentinib, a first-in-class selective
oral AXL inhibitor, in combination with low-dose cytarabine (LDAC)
or decitabine as a potential new treatment regimen for acute
myeloid leukaemia (AML) patients unable to tolerate intensive
therapy. The data will be presented at the 2019 annual meeting of
the American Society of Clinical Oncology (ASCO), Chicago, Illinois (31 May - 4 June 2019).
In total, 33 patients were enrolled into the trial: 16 into the
LDAC + bemcentinib group, of which 13 are evaluable for efficacy to
date, and 17 into the decitabine + bemcentinib group, of which 12
are evaluable for efficacy to date.
Among the 13 evaluable patients in the LDAC + bemcentinib group,
6 responses have been reported; 4 patients achieved complete
remission / complete remission with incomplete hematologic recovery
(CR/CRi) and 2 patients' partial remission (PR). This yields an
overall response rate (ORR) of 46%, including 31% CR/CRi among
elderly AML patients (>70 years). Furthermore, one patient
achieved durable stable disease for more than 3 months. The relapse
free survival rate (RFS) for patients with CR/CRi is 6.2 months
(0.7 to 9.6 months); data immature.
In the decitabine/bemcentinib group, of the 12 evaluable
patients, 3 responses have been reported; 1 patient achieved CR/CRi
and 2 patients PR. This yields an ORR of 25%. Furthermore, five
patients had durable stable disease for more than 3 months. The RFS
for patients with CR/CRi is 5 months; data immature.
The combination treatment of bemcentinib and LDAC or decitabine
was overall well-tolerated; the most common adverse events (>15%
of patients) included anaemia, neutropenia and diarrhoea. No grade
5 TRAEs were reported and all events were reversible.
Professor Sonja Loges,
attending physician and principal investigator, University Medical
Centre Hamburg Eppendorf, Germany
commented: "These early results are very encouraging,
particularly as we have seen responses in a less fit AML patient
population with comparatively poor prognosis [having not responded
to first-line therapies], or with high risk cytogenetics. These
data show that bemcentinib in combination with LDAC resulted in a
significantly higher ORR than previously observed/historical
benchmarks in single-agent cytarabine. These early results warrant
further investigation of bemcentinib in a larger trial addressing
AML patients unfit for intensive chemotherapy."
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "A majority of
AML patients are unable to tolerate intensive chemotherapy and have
limited treatment options, particularly if established first-line
therapies fail. These combination trials of bemcentinib with
low-dose cytarabine and decitabine show promising results that the
addition of our selective AXL inhibitor will improve the outcome of
treatment with these much-used agents. Although these are early
findings, we are encouraged by the emerging clinical data and
focused on advancing our late stage development programme."
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
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 3709 5700
Media Relations in Norway
Jan Petter Stiff, Crux
Advisers
stiff@crux.no
+47 995 13 891
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.
This information is subject to the disclosure requirements
pursuant to section 5-12 of the Norwegian Securities Trading
Act.
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