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· Combination is 5-fold more active in composite AXL positive patients (33%
ORR) vs AXL negative patients (7% ORR)
· Secondary endpoint, median Progression Free Survival of 8.4 months in
composite AXL score positive patients, exceeds expectations, 3-fold longer than
for composite AXL negative patients.
Bergen, Norway, 8 November 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, today presents comprehensive clinical and
translational data from Cohort A of its Phase II clinical trial (BGBC008)
evaluating bemcentinib, its first in class selective AXL inhibitor, in
combination with MSD’s, (a tradename of Merck & Co., Inc., Kenilworth, NJ., USA)
anti-PD-1 therapy KEYTRUDA® (pembrolizumab), as a potential new treatment
regimen for previously treated advanced non-small cell lung cancer (NSCLC) at an
oral presentation at the prestigious High Impact Clinical Trial session at the
Society for Immunotherapy of Cancer (6-10 November 2019) conference in
Washington DC.
In cohort A, 44 patients were evaluable for response; of IHC evaluable patients:
50% were composite AXL positive, 52% were PD-L1 negative (<1%TPS), and 38%
patients were PD-L1 low positive (1-49% TPS). The primary endpoint of Overall
Response Rate (ORR) was met, with 33% ORR in AXL positive patients; five times
the response rate of AXL negative patients (7%).
A secondary endpoint of median Progression Free Survival (mPFS) reported
significant 3-fold improvement in AXL positive vs negative patients - 8.4 months
in composite AXL positive patients significantly surpassing what has been shown
historically in second line treatment with PD-1 inhibitor monotherapy.
Dr. Matthew Krebs, MD, PhD, the lead investigator who will give the presentation
at SITC said: “The clinical benefit seen with the drug combination in AXL
positive patients is impressive and provides a potential new treatment approach
for patients with low or negative PD-L1 status. The mPFS observed for the AXL
positive patients is far higher than that seen with pembrolizumab monotherapy
results from earlier clinical trials for patients with PD-L1<50%. Furthermore,
the combination is well tolerated by patients.”
RNA sequence analysis of pretreatment patient biopsies revealed that clinical
benefit from the combination therapy correlates with total tumor AXL expression.
A proprietary predictive signature for response to bemcentinib and pembrolizumab
combination derived from the transcriptional analysis is enriched for genes
associated with epithelial-to-mesenchymal transition (EMT) and myeloid cell
activation. “This is exactly where we know AXL is important.” added Professor
James Lorens PhD, Chief Scientific Officer of BerGenBio.
The gene expression measured in responding patients correlates with gene
signatures known to be associated with poor prognosis and lack of response to
immunotherapy. This indicates that previously treated patients are particularly
benefiting despite exhibiting these adverse traits. Professor Hani Gabra MD PhD,
Chief Medical Officer of BerGenBio said: “This indicates that bemcentinib is
conditioning the tumor microenvironment in AXL positive patients and optimizing
pembrolizumab response in these previously treated patients.”
Multispectral immunofluorescence analysis detected tumor infiltrating AXL
-expressing macrophages closely adjacent to T cells in the tumors of patients
who responded to the combination therapy. “Seeing the AXL expressing macrophages
interacting with T regulatory cells in the tumor of a patient who responded to
the treatment really underscores the potential.” added Dr. Krebs.
Prof. Lorens added: “Previously we only considered AXL expression in the tumor
cells, ignoring the immune cell compartment of the tumor. Our deeper biomarker
analysis clearly shows that our earlier tumor cell-only score did not fully
capture the population of patients who benefit from the combination.” A
proprietary composite AXL tumor-immune score has now been developed, derived
from gene expression and immunohistochemistry analysis that selects patients
likely to benefit from bemcentinib.
Richard Godfrey, Chief Executive Officer of BerGenBio, said: “Our improved
ability to select and predict patients with durable clinical benefit with a
refined AXL composite biomarker is an important development for our AXL
targeting clinical programs. Importantly for patients is the prolonged duration
of benefit or mPFS and improved Overall Survival (mOS), which is still maturing,
these are also critical regulatory end points. I look forward to reporting mOS
and data from additional cohorts in the coming months.”
Presentation details
A phase II study of bemcentinib (BGB324), a first-in-class selective AXL
inhibitor, in combination with pembrolizumab in patients with advanced NSCLC:
Updated analysis
· Matthew G. Krebs, MD, PhD -The University of Manchester
· Concurrent Session 206: High Impact Clinical Trials
· Oral Session
· 08 November 2019: Prince George’s Exhibition Hall C
· 5:10 - 5:25 p.m. EST (Session runs from 4:50 - 6:15 p.m.)
Presentation will be available at www.bergenbio.com in the section:
Investors/Presentations when the presentation starts.
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. Tumour AXL expression is associated with poor
prognosis in NSCLC and most other cancer types. 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, 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 AXL antibody (BGB149) and an AXL
-ADC (ADCT-601) are 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). 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, Lucy Featherstone
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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