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study of bemcentinib in combination with erlotinib in patients with advanced non
-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology
(ASCO) Annual Meeting.
Study Design
Phase I of the study was a dose escalation arm designed to confirm the safety
and tolerability of bemcentinib in NSCLC patients as both monotherapy and in
combination with erlotinib in patients whose disease had previously progressed
on erlotinib alone.
Phase II assessed patients in two groups; those whose disease had progressed on
an approved EGFR inhibitor, and those who were responding/stable on erlotinib as
a first line treatment. Both groups were treated with bemcentinib and erlotinib
to evaluate the safety and activity of the combination, while assessing reversal
or prevention of resistance to EGFR inhibition.
Conclusions
Data from the study found that Bemcentinib in combination with erlotinib was
well tolerated over extended periods of time, with the longest ongoing patients
having been dosed for over 46 months.
The combination led to disease stabilisation and durable tumour responses in a
proportion of patients who had previously progressed on EGFR targeted therapy
and who were negative for the T790M resistance mutation. In patients who were
responding to first line treatment with erlotinib, either stable disease or
partial response, the addition of bemcentinib led to further deepening of
responses and prolonged the duration of responses beyond 30 months in 4 out of
the 13 patients evaluated. At the time of data cut-off, 2 patients are still
participating in the study beyond 34 months of treatment. Ongoing patients at
the time of study closure, who wish to continue receiving study treatment, will
be offered the drug via an expanded access program.
Presenting author Lauren Byers, M.D., associate professor of Thoracic/Head and
Neck Medical Oncology at the University of Texas MD Anderson Cancer Center, in
Houston, said “We are encouraged by the responses observed both in patients
whose disease was progressing on EGFRi alone, as well as patients already in
remission with erlotinib. In particular we were pleased to see durable responses
exhibited by a number of patients on the study, with two patients continuing to
be dosed with bemcentinib beyond 36 months. This is a good indicator that
bemcentinib offers excellent tolerability as well as the potential for anti
-tumour activity and we look forward to following their progress as their
treatment continues.”
Byers reports past advisory board participation for BerGenBio.
Richard Godfrey, CEO of BerGenBio said “This end of study data shows the
potential of bemcentinib as a combination treatment alongside EGFR inhibitors
such as erlotinib and osimertinib, which are established treatments and widely
used in indications such as NSCLC in patients with the EGFR driver mutation. We
believe that further clinical investigation is needed to fully explore this
potential, and look forward to discussing our findings further with our
colleagues at ASCO.”
Details of the presentation, also available on the investor section of
BerGenBio’s website, are as follows:
Title: Ph I/II study of oral selective AXL inhibitor bemcentinib (BGB324) in
combination with erlotinib in patients with advanced EGFRm NSCLC: end of trial
update
Session: Lung Cancer - Non-Small Cell Metastatic
Abstract ID: 9110
Date/Time: Friday, June 4, 2021 at 9:00 AM (EDT)
Author: Byers et al.
-Ends-
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying life-threatening diseases.
In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor
to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters
the host cell, and AXL expression is upregulated that leads to suppression of
the Type 1 Interferon immune response by host cells and in their environment.
Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and
promotes the anti-viral Type I interferon response. Data from a Phase II in
human clinical trial has shown that treatment with AXL inhibitor bemcentinib
increased the rate of ventilator free survival in hospitalised COVID-19
patients.
In cancer, increase in AXL expression has been linked to key mechanisms of drug
resistance and immune escape by tumour cells, leading to aggressive metastatic
cancers. AXL suppresses the body’s immune response to tumours and drives
treatment failure across many cancers. High AXL expression defines a very poor
prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib,
therefore, have potential high value as monotherapy and as the cornerstone 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 including
fibrosis.
About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent
and highly selective AXL inhibitor, currently in a broad phase II clinical
development programme. It is administered as an oral capsule and taken once per
day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and
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.
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 clinical development
programme focused on combination and single agent therapy in cancer, leukaemia
and COVID-19. A first-in-class functional blocking anti-AXL
antibody, tilvestamab, is undergoing phase I clinical testing. In
parallel, BerGenBio is developing a companion diagnostic test to identify
patient populations most likely to benefit from AXL inhibition: 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
ir@bergenbio.com
Richard Godfrey CEO, BerGenBio ASA
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, 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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