BERGEN, Norway, Feb. 19, 2018 /PRNewswire/ -- BerGenBio ASA
(OSE: BGBIO) announces that it has completed enrolment, ahead of
schedule, of the planned 28 patients into the first stage of its
Phase II clinical trial evaluating its investigational oral
selective AXL inhibitor bemcentinib (BGB324) in combination with
the Merck & Co., Inc., Kenilworth,
N.J., USA (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA®
(pembrolizumab) as a potential new treatment regimen for advanced
breast cancer.
The Phase II trial (BGBC007) follows a two-stage design: it is
an open label, multi-centre study of bemcentinib in combination
with KEYTRUDA in patients with previously treated, locally advanced
and unresectable or metastatic triple negative breast cancer (TNBC)
or triple negative inflammatory breast cancer (TN-IBC). Up to 56
patients in total will be included in the study (NCT03184558).
The trial is designed to evaluate efficacy and safety of the
combination, and to correlate the patient response with biomarker
status (AXL kinase and PD-L1 expression). In parallel, companion
diagnostics using these biomarkers, and others, are being developed
for the identification of patients predicted to be most suitable
for treatment with the bemcentinib / KEYTRUDA combination. Interim
results are expected mid-year 2018.
The trial, which began in October
2017, is being conducted under a clinical collaboration with
Merck & Co., Inc., Kenilworth,
N.J., USA, through a subsidiary, and is taking place at more
than 16 clinical sites in the US and Europe.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "We are delighted to
have completed patient enrolment into the first part of this Phase
II trial in such a short time and ahead of schedule.
Immuno-oncology therapies, such as KEYTRUDA, are now established as
a major treatment option for cancer patients and we are excited
with the progress being seen across our clinical trials exploring
if bemcentinib in combination with KEYTRUDA can result in
significantly improved patient outcomes. Positive results from
these trials, and from our broader Phase II development programme
will help confirm the great potential we see for bemcentinib as a
cornerstone therapy across multiple cancer indications and in
combination with existing and emerging modalities of cancer
treatment. We look forward to interim results from this and other
studies during 2018."
Preliminary safety data, reported at the ASCO-SITC Clinical
Immuno-Oncology Symposium (January
2018), found that the bemcentinib / KEYTRUDA combination was
well tolerated in a sample of patients across three cancer
indications in which it is being studied (advanced breast cancer,
lung cancer and melanoma) with a safety profile similar to KEYTRUDA
alone. Nineteen of the 34 patients evaluated in this analysis were
from the BGBC007 breast cancer trial.
About TNBC
Breast cancer is the most common cancer in women – it is
estimated that more than 250,000 new cases will be diagnosed in the
US in 2018. 20% of breast cancers lack receptors for three common
hormones (oestrogen, progesterone and HER2) and are thus called
triple-negative breast cancers (TNBC). Treatment options for TNBC
are limited to intense chemotherapy, but disease recurrence is
frequent and aggressive. Consequently, novel treatment strategies
for TNBC are urgently needed.
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 (BGB324), 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
commercialization 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
Tom Henrik Sundby
Finance Director
BerGenBio ASA
tom.sundby@bergenbio.com
+47-477-54-415
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.
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SOURCE BerGenBio ASA