Regulatory Filings • Jun 2, 2019
Regulatory Filings
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BerGenBio presents new preliminary clinical and biomarker data showing durable response & median survival rates in Phase II trial with bemcentinib and KEYTRUDA in pts with advanced NSCLC at ASCO 2019
· Phase II trial evaluating bemcentinib in combination with KEYTRUDA in
advanced NSCLC patients shows 12-month survival data surpassing historical
benchmarks in second-line treatment with PD-1 inhibitor monotherapy
· Promising clinical activity continues to be seen, particularly in patients
with AXL positive tumours including those with low or no PD-L1 expression
Chicago, USA, 02 June 2019 - BerGenBio ASA (OSE: BGBIO) a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, today presents updated data from its Phase II
clinical trial (BGBC008, NCT03184571) with bemcentinib and Merck's anti-PD-1
therapy KEYTRUDA (pembrolizumab) in patients with advanced non-small cell lung
cancer (NSCLC) at the 2019 annual meeting of the American Society of Clinical
Oncology (ASCO) in Chicago, Illinois (31 May - 4 June 2019).
At data cut off, 35 out of 46 enrolled patients were evaluable; 58% were AXL
+ve, and 53% were PD-L1 negative (<1%TPS), and a further 39% were PD-L1 (1-49%
TPS). An objective response rate of 40% was achieved in AXL +ve patients,
irrespective of the patients PD-L1 score; and an overall response rate of 29%
was achieved. The median survival rate of 12.2 months was observed at the time
of data cut-off, significantly surpassing what has been shown historically in
second line treatment with PD-1 inhibitor monotherapy.
The combination treatment of bemcentinib and pembrolizumab was overall well
-tolerated; the most common adverse events included transaminase increase (35%),
fatigue (30%), and diarrhoea (26%). No grade 5 treatment related adverse events
were reported and all events were reversible.
Principal investigator Enriqueta Filip, Vall d'Hebron University Hospital,
Barcelona
" Following the rapid uptake of checkpoint inhibitors in first-line lung cancer
therapy, treatment options for NSCLC cancer patients that have not responded to
anti-PD-1 therapies such as KEYTRUDA represent a significant unmet medical
need. These data, which suggest that combination therapy with bemcentinib has
the potential to enhance patient responses to these novel agents, particularly
in patients with no or limited expression of PD-L1, is a very significant and
encouraging development."
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "The clinical
activity we are presenting here today surpasses what has been shown historically
in previously-treated, PD-L1 low patients on PD-1 inhibitor monotherapy, and
supports the hypothesis that AXL is implicated in the failure of anti-PD-L1
therapies. Further investigation is warranted and having recently extended the
trial to include patients showing disease progression on checkpoint inhibitors,
we will continue to test this hypothesis and look forward to providing further
updates during 2019."
-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
non-small cell lung cancers (NSCLC) 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 BerGenBio
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 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
+47 917 86 513
International Media and Investor 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.
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