Regulatory Filings • Oct 5, 2018
Regulatory Filings
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BerGenBio enters second stage of phase II trial with selective AXL inhibitor bemcentinib in combination with KEYTRUDA® in patients with advanced NSCLC
Bergen, Norway, 5 October 2018- BerGenBio ASA (OSE: BGBIO) announces that the
first patient has been dosed in the second stage of the phase II trial (BGBC008)
evaluating the Company's selective AXL inhibitor bemcentinib in combination with
MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with previously
treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC)
whose disease is progressing.
The trial was advanced into the second stage on the basis that the first stage
met its clinical efficacy endpoint (as announced on 26 June 2018). Updated
results from the first stage (n=24) were presented at the 19th Annual World
Conference on Lung Cancer (WCLC; 25 September 2018)*. The Company reported an
overall response rate (ORR) of 40% in patients who tested positive for AXL
expression (4 out of 10 pts). Efficacy was also seen in PD-L1 negative patients
(ORR of 27%, 3 out of 11 pts) for whom KEYTRUDA monotherapy is currently not
indicated. Treatment with the bemcentinib/KEYTRUDA combination was well
tolerated.
The second stage will enrol a further 24 patients at sites in Norway, Spain, UK
and the US, and aims to confirm the safety and clinical efficacy of the
combination. Comprehensive exploratory studies will continue to evaluate
biomarkers in tumour and blood indicative of AXL expression and immune
modulation. Preliminary results from the trial are expected during 2019.
The BGBC008 trial (ClinicalTrials.gov Identifier: NCT03184571) is being
sponsored by BerGenBio. MSD, a tradename of Merck & Co., Inc., Kenilworth, New
Jersey, USA, will continue to supply KEYTRUDA for use in the study under a
collaboration agreement signed in March 2017.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We recently
reported positive data from this phase II clinical trial at WCLC. Patients that
were AXL positive reported a clinical response rate of 40%. Most notably, this
included PD-L1 negative patients who do not benefit from KEYTRUDA monotherapy.
These data strengthen our confidence in bemcentinib's mode of action, as well as
the value of AXL inhibition to enhance patient outcomes to KEYTRUDA
immunotherapy. Additional combination data in NSCLC, including bemcentinib with
targeted and chemotherapy, also presented at WCLC provide further proof
supporting the concept that AXL is a key player in mediating resistance to
therapy and immune evasion, and that bemcentinib has the potential to become a
cornerstone therapy in this challenging indication. We look forward to reporting
outcome and biomarker data at upcoming leading medical congresses."
* James Lorens et al. Ph II Study of Oral Selective AXL Inhibitor Bemcentinib
(BGB324) in Combination with Pembrolizumab in Patients with Advanced NSCLC
(abstract P2.04-27)
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary
of Merck & Co., Inc., Kenilworth, NJ, USA.
END
About NSCLC
It is estimated that more than 230,000 new cases of lung cancer will be
diagnosed in the US in 2018 and it is the leading cause of cancer deaths. 65% of
NSCLCs are of adenocarcinoma pathology. Although various treatments exist for
NSCLC, they are often curtailed by acquired resistance to therapy and immune
evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently
required.
About the BGBC008 trial
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).
For more information please access trial NCT03184571 at www.clinicaltrials.gov.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
advanced and aggressive cancers.
The company's proprietary lead candidate, bemcentinib, 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.
In parallel, BerGenBio is developing companion diagnostics test to identify
patient populations most likely to benefit from bemcentinib; this is expected to
facilitate more efficient registration trials and support 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
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms that drive aggressive and life-threatening diseases. In
cancer, AXL drives tumour survival, treatment resistance and spread, as well as
suppressing the body's immune response to tumours. AXL expression has been
established as a negative prognostic factor in many cancers. AXL inhibitors,
therefore, have potential value at the centre of cancer combination therapy,
addressing significant unmet medical needs and multiple high-value market
opportunities.
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
This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
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