BERGEN, Norway, June 26, 2018 BerGenBio ASA (OSE:BGBIO) announces
today that on a top-line, preliminary basis, the first efficacy
endpoint has been met in its Phase II clinical trial (BGBC008)
evaluating bemcentinib, a first-in-class oral selective AXL
inhibitor, in combination with the Merck & Co., Inc.,
Kenilworth, N.J., USA[1] anti-PD-1
therapy KEYTRUDA® (pembrolizumab) as a potential new treatment
regimen for advanced non-small cell lung cancer (NSCLC). The
primary efficacy endpoint requires at least four patients (out of
the first 22 treated patients) to achieve clinical responses when
treated with the novel drug combination, defined as either complete
or partial response, as measured by Response Evaluation Criteria in
Solid Tumors (RECIST).
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "Immunotherapy has
become a major component of the treatment of many cancers –
patients who respond to immune checkpoint inhibitors like KEYTRUDA
enjoy long-term disease control with excellent quality of life.
Unfortunately, only a minority of lung cancer patients receiving
KEYTRUDA monotherapy in second-line respond to treatment. The
BGBC008 combination trial of bemcentinib with KEYTRUDA evaluates
whether the addition of our selective AXL inhibitor will improve
the outcome of immunotherapy.
"Clearing the first efficacy threshold in this ongoing Phase II
trial is very encouraging and we intend to begin enrolment for
Stage 2 of this study in which 24 further patients will be enrolled
under the same protocol. Thus far, we are delighted to see activity
in a number of patients receiving this novel treatment regimen. A
particularly encouraging finding is that we see responses in
patients who are negative for the PD-L1 biomarker, for whom
KEYTRUDA monotherapy is not indicated. The second stage of the
trial is intended to confirm activity and biomarker correlation in
a larger group of patients – comprehensive analysis of the Phase II
data will continue and will be presented at a future scientific
conference.
"Successfully completing this important milestone further
supports our belief in the potential of bemcentinib to become a
cornerstone of cancer therapy. We look forward to sharing more
details from our Phase II clinical programme during major clinical
conferences in the coming months."
About the BGBC008 trial combining bemcentinib with KEYTRUDA
(pembrolizumab) conducted in collaboration with Merck & Co.,
Inc.
Design
The BGBC008 trial is a Phase II multi-centre open-label study
of bemcentinib in combination with KEYTRUDA
(pembrolizumab) in previously treated, immunotherapy naïve,
patients with advanced adenocarcinoma of the lung, the most common
form of non-small cell lung cancer (NSCLC). 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).
A pre-defined efficacy endpoint was set at four or more
responses observed in the first 22 patients based on previously
reported response rates to KEYTRUDA monotherapy in the second line
setting in NSCLC.
Status June 2018
To date, 4 responses (partial responses as per RECIST v1.1) have
been observed in the first 22 patients. A number of patients remain
ongoing and are awaiting the confirmation of their best
response.
Patients generally tolerated the novel drug combination well –
no new safety events were reported from the combination of
bemcentinib with KEYTRUDA at full dose.
A preliminary interim analysis of the trial (from 15 patients
evaluable for response) was presented at ASCO 2018, where tumour
shrinkage was observed in about half of the patients analysed to
date. Results looked particularly promising in patients who did not
express the PD-L1 biomarker, i.e. representing 1/3 of NSCLC
patients, a group for whom KEYTRUDA monotherapy as a second line is
not indicated.
For more information please access trial NCT03184571 at
www.clinicaltrials.gov.
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company
focused on developing a pipeline of first-in-class AXL kinase
inhibitors as a potential cornerstone of combination cancer
therapy. The Company is a world leader in understanding the
essential role of AXL kinase in mediating cancer spread, immune
evasion and drug resistance in multiple aggressive solid and
haematological cancers.
BerGenBio's lead product, bemcentinib, is a selective, potent
and orally bio-available small molecule AXL inhibitor in four
Company sponsored Phase II clinical trials in major cancer
indications, with read-outs anticipated during 2018. It is the only
selective AXL inhibitor in clinical development.
The Company sponsored clinical trials are:
- Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation
driven non-small cell lung cancer (NSCLC)
- Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the
lung, and
- Bemcentinib with KEYTRUDA in triple-negative breast cancer
(TNBC).
- Bemcentinib as a single agent and combination therapy in acute
myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)
The clinical trials combining bemcentinib with KEYTRUDA in
adenocarcinoma of the lung and TNBC are conducted in collaboration
with Merck & Co., Inc., Kenilworth,
NJ, USA, through a subsidiary.
In addition, a number of investigator-sponsored trials are
underway, including a trial to investigate bemcentinib with either
MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in
advanced melanoma, as well as a trial combining bemcentinib with
docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic
test to identify patient subpopulations most likely to benefit from
treatment with bemcentinib. This will facilitate more efficient
registration trials and support a precision medicine based
commercialisation strategy.
The Company is also developing a diversified pre-clinical
pipeline of drug candidates, including BGB149, an anti-AXL
monoclonal antibody.
For further information, please visit:
www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. TARCEVA® is a registered
trademark of OSI Pharmaceuticals, LLC., marketed by
Roche-Genentech. TAFLINAR® is a registered trademark of
Novartis International AG and MEKINIST® is a registered trademark
of GSK plc.
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47-917-86-304
Rune Skeie, CFO, BerGenBio
ASA
rune.skeie@bergenbio.com
+47-917-86-513
Media Relations in Norway
Jan
Petter Stiff, Crux Advisers
stiff@crux.no
+47-995-13-891
International Media Relations
David Dible, Mark
Swallow, Marine Perrier
Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44-207-638-9571
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.
[1] Known as MSD outside the
United States and Canada
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SOURCE BerGenBio ASA