Regulatory Filings • May 8, 2019
Regulatory Filings
Open in ViewerOpens in native device viewer
BerGenBio completes recruitment into second stage of Phase II trial with selective AXL inhibitor bemcentinib in combination with KEYTRUDA® in patients with advanced NSCLC
· 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, 08 May 2019 - 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."
- End -
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
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, 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.
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.