- Phase II, Simon two-stage trial evaluating bemcentinib and
KEYTRUDA in previously treated NSCLC post chemotherapy (Cohort A,
NCT03184571)
- First stage previously met efficacy endpoint
- Second stage enrolled a further 24 patients for a total of 48;
efficacy and biomarker data updates expected at medical conferences
during 2019
BERGEN, Norway, May 8, 2019 /PRNewswire/ -- BerGenBio ASA (OSE:
BGBIO) announces that it has completed enrolment into the second
stage of its Phase II trial (BGBC008, Cohort A NCT03184571)
evaluating the Company's selective AXL inhibitor bemcentinib in
combination with MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab),
in patients with previously treated advanced adenocarcinoma of the
lung (non-small cell lung cancer, NSCLC) whose disease is
progressing on or after prior systemic chemotherapy.
The trial has previously met the efficacy endpoint in the first
stage and reported preliminary efficacy including a 40% ORR and 5.9
months Progression-free survival (PFS) in AXL positive patients
(n=10). The second stage of the trial enrolling a further 24
patients for a total of 48 is designed to confirm the safety,
clinical efficacy and biomarker correlation of the combination.
Comprehensive exploratory studies will continue to evaluate
biomarkers in tumour and blood indicative of AXL expression and
immune modulation. Results from the trial are expected during
2019.
The trial, which began in October
2017, is being conducted under a clinical collaboration with
Merck & Co., Inc., Kenilworth,
N.J., USA, through a subsidiary, and is taking place at
sites in the US, UK, Norway and
Spain.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "A majority of
NSCLC patients now receive anti-PD(L)-1 therapies like KEYTRUDA as
a first- or second-line treatment for their advanced disease.
Enhancing responses to these novel agents, particularly in patients
with no or limited expression of PD-L1, the established biomarker
for these drugs, is a significant unmet need. I am encouraged by
the efficacy signals seen during stage 1 of the trial, particularly
in AXL positive, and often PD-L1 negative or low, patients and look
forward providing data from an extended dataset during the coming
months together with further details on our late stage strategy in
this indication."
About NSCLC
It is estimated that more than 230,000 new cases of lung cancer
have been diagnosed in the US in 2018 and it is the leading cause
of cancer deaths. 65% of NSCLCs are of adenocarcinoma pathology.
Although various treatments exist for NSCLC, they are often
curtailed by acquired resistance to therapy and immune evasion.
Novel treatments overcoming these mechanisms in NSCLC are urgently
required.
About the BGBC008 trial
The BGBC008 trial is a Phase II open-label study
of bemcentinib in combination with KEYTRUDA
(pembrolizumab) in previously treated patients with advanced
adenocarcinoma of the lung run at centres in the US, UK,
Spain and Norway. The objective of the trial is to
determine the anti-tumour activity of this novel drug combination
and responses will be correlated with biomarker status (including
AXL kinase and PD-L1 expression).
Patients eligible for participation in Cohort A must have
progressed on or after prior therapy excluding immunotherapy
whereas patients in Cohort B will be actively progressing on a
therapy regimen containing an anti-PD(L)-1 therapy.
Both cohorts follow a two-stage design, Cohort A has previously
successfully progressed into the second stage after meeting its
first efficacy endpoint. Cohort B will evaluate advancement into
stage 2 after 13 patients have been assessed for response.
For more information please access trial NCT03184571 at
www.clinicaltrials.gov.
About AXL
AXL kinase is a cell membrane receptor and an essential mediator
of the biological mechanisms that drive aggressive and
life-threatening diseases. In cancer, AXL drives tumour survival,
treatment resistance and spread, as well as suppressing the body's
immune response to tumours. AXL expression has been established as
a negative prognostic factor in many cancers. AXL inhibitors,
therefore, have potential value at the centre of cancer combination
therapy, addressing significant unmet medical needs and multiple
high-value market opportunities.
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 focussed on combination and single
agent therapy in lung cancer and leukaemia. A first-in-class
functional blocking anti-AXL antibody is undergoing Phase 1
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, 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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