- Phase II trial evaluating bemcentinib in combination with
low-dose cytarabine (LDAC) in elderly AML patients unfit for
intensive therapy is well tolerated and shows promising
efficacy
- Long duration of response (>9.9 mo, still maturing) with
50% CR/CRi in 6 evaluable newly diagnosed patients receiving the
bemcentinib-LDAC combination.
- Clinical benefit demonstrated in >2L relapsed and
refractory AML patients with 1 CR/CRi and 3 SD out of 6 evaluable
patients
- Pretreatment sAXL holds as predictive of response
BERGEN, Norway, Dec. 9, 2019 /PRNewswire/ -- BerGenBio ASA
(OSE:BGBIO), a clinical-stage biopharmaceutical company developing
novel, selective AXL kinase inhibitors for multiple cancer
indications, will today provide an update from the Company's phase
II study of bemcentinib (BGB324), a first-in-class highly selective
oral AXL inhibitor, in combination with low-dose cytarabine (LDAC)
in elderly AML patients in a poster presentation at the 61st Annual
American Society of Hematology (ASH) Meeting, being held from 7-10
December in Orlando, Florida.
The bemcentinib-LDAC combination was safe and well tolerated in
elderly AML patients and showed promising efficacy among both newly
diagnosed and relapsed/refractory AML patients. The overall
response rate and duration surpass historical benchmarks and
compare favorably to other LDAC combinations. Pretreatment sAXL
holds as a predictive biomarker in AML patients treated with the
combination, and a new novel blood based predictive biomarker is
identified and associated with clinical benefit in AML and Lung
cancer patients receiving bemcentinib.
Professor Sonja Loges,
attending physician and principal investigator, University Medical
Centre Hamburg Eppendorf, Germany
commented: "I am very encouraged by these early results.
The duration of response and successful treatment beyond
progression are consistent with the previously reported
immunomodulatory activity of bemcentinib. I look forward to
conducting a deeper analysis of AXL signalling in tumor and immune
cells from patient biopsy samples to further elucidate this unique
mechanism-of-action."
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "This combination
trial of bemcentinib with low-dose cytarabine continues to show
promising results in AML patients who are unable to tolerate
intensive chemotherapy and have limited treatment options. The
current data further highlight the novel tumor-immune effects of
bemcentinib observed in previous cohorts and in other cancer types.
Although these are early findings, we are encouraged by the
response rate and duration, and we are focused on advancing our
late stage development programme."
Details of the presentation are below.
Title: Durable responses observed in elderly AML
patients unfit for intensive chemotherapy with first-in class
selective AXL inhibitor bemcentinib (BGB324) in combination with
LDAC: Phase II open-label study
Date: Monday 9th December
2019
Session Name: 616. Acute Myeloid Leukemia: Novel
Therapy, excluding Transplantation: Poster III
Time, Location: 6:00 PM -
8:00 PM, Orange County Convention Center, Hall B
The poster will be available at www.bergenbio.com in the
section: Investors/Presentations from 14.00 CET Monday
9th December 2019.
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, drug 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 anti-AXL antibody is 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). For more information,
visit 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, Nicholas
Brown, Lucy Featherstone,
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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