Earnings Release • Jun 3, 2019
Earnings Release
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BerGenBio presents new Phase II clinical data that bemcentinib in combination with low dose chemotherapy improves efficacy and duration of survival in elderly AML patients at ASCO 2019
· 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
Chicago, USA, 03 June 2019 - 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."
- END -
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
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, Jessica Hodgson, Nicholas Brown, Carina Jurs,
Consilium Strategic Communications
+44 20 3709 5700
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
+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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