- Primary endpoint, Overall Response Rate, has been met in
predominantly PD-L1 negative/low patients
- Secondary endpoint, median Progression Free Survival, exceeds
expectations in AXL positive patients
- Data to be presented at Society for Immunotherapy of Cancer
34th Annual Meeting on 8 November
2019
OSLO, Nov. 6, 2019 /PRNewswire/ -- 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
- 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.
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http://news.cision.com
The following files are available for download:
https://mb.cision.com/Main/15728/2954767/1136403.pdf
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