Regulatory Filings • Jun 26, 2018
Regulatory Filings
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Selective AXL inhibitor bemcentinib meets pre-specified efficacy endpoint in stage 1 of NSCLC phase II combination trial with KEYTRUDA®
· Clinical response merits initiation of stage 2 of the Phase II combination
trial
· 24 patients treated to date, 48 patients to be treated in total
· Responses will be correlated with AXL and PD-L1 biomarkers
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] (http://applewebdata//E8485AAB-168D-4F0B-91C7
-67381DF3249E#_ftn1) 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.
- END -
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
+47 917 86 513
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
+47 995 13 891
International Media Relations
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
+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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[1] (http://applewebdata//E8485AAB-168D-4F0B-91C7-67381DF3249E#_ftnref1) Known
as MSD outside the United States and Canada
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