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in AXL positive patients
· Data to be presented at Society for Immunotherapy of Cancer 34th Annual
Meeting on 8 November 2019
Bergen, Norway, 6 November 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, announces today that the primary endpoint of
Overall Response Rate (ORR) has been met in Cohort A of its Phase II clinical
trial (BGBC008) evaluating bemcentinib, its first in class selective AXL
inhibitor, in combination with the 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). The primary efficacy endpoint requires that at least 25%
evaluable patients achieve a clinical response when treated with the novel drug
combination, defined as either complete or partial response, as measured by
Response Evaluation Criteria in Solid Tumors (RECIST).
A secondary endpoint of median Progression Free Survival (mPFS) reported
significant 3-fold improvement in AXL positive vs negative patients, as defined
by BerGenBio’s composite AXL tumor-immune score.
These data will be presented during at the Society for Immunotherapy of Cancer
in the High Impact Clinical Trials session on Friday 8 November in a
presentation entitled: 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.
Professor Hani Gabra MD PhD, Chief Medical Officer of BerGenBio, commented: “I
am impressed by these results that clearly demonstrate the durable clinical
benefits in this difficult to treat low PD-L1 patient population. Importantly
the patients that benefit most match gene signatures that predict poor prognosis
and a lack of response to immunotherapy in NSCLC”.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “I am
delighted to see continued significant patient benefit from bemcentinib in
combination with Keytruda. This is the first of three cohorts where we are
evaluating this combination in previously treated lung cancer patients and I
look forward to reporting data from these 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, 4:50 - 6:15 p.m. EST
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, 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.
Kilde
