CHICAGO, June 3, 2018 /PRNewswire/ -- BerGenBio ASA
(OSE:BGBIO) announces that interim data from its Phase II clinical
development programme with bemcentinib, a selective AXL inhibitor,
was presented at a reception hosted yesterday by the company in
Chicago, IL, USA. The reception,
which coincides with the annual American Society of Clinical
Oncology (ASCO) meeting, provided stakeholders, including
clinicians, investors, analysts and media, with interim data from
the ongoing clinical trials of bemcentinib alone and in combination
with standard of care drugs in multiple cancer indications.
Presentations were made by key opinion leaders, clinical trial
principle investigators and members of the BerGenBio team.
All materials presented at the reception are available on the
BerGenBio website in the Investors / Presentations section. A
conference call to discuss the presentations and updates will be
held on Monday 4thJune at 8:30 AM
CEST (details below).
Key Findings
Note that all Phase II trials are ongoing and results
presented are preliminary and subject to change as the trials
progress to completion. Updated data will be presented throughout
2018.
- Bemcentinib plus KEYTRUDA® (pembrolizumab) shows early promise
in advanced lung cancer (NSCLC) patients who failed previous
treatment (study BGBC008):
-
- Tumour shrinkage was reported in 8 of 15 evaluable patients to
date, including three Partial Responses (PR) and one mixed
response,
- Response assessment according to biomarker expression analysis
available thus far:
-
- 6 of 7 PD-L1 negative patients reported clinical benefit,
including 2 PRs and 2 patients with evidence of tumour
shrinkage.
- 5 of 6 patients thus far tested for AXL expression with
BerGenBio's proprietary immunohistochemistry assay, were AXL
positive.
- 4 of 5 AXL positive patients reported clinical benefit
including 1 PR and 2 patients with evidence of tumour
shrinkage.
- All 4 AXL positive patients reporting clinical benefit were
found to be PD-L1 negative.
- An acceptable safety profile of the combination was reported
with only a minority of patients experiencing fully reversible
adverse events.
- Analysis of metastatic triple-negative breast cancer (TNBC)
patients who had failed previous treatment and who were enrolled to
receive bemcentinib plus KEYTRUDA (study BGBC007) showed low
prevalence of AXL and PD-L1:
-
- 14 of 18 patients tested for AXL expression were AXL negative
and reported no benefit.
- 12 of 15 patients tested for PD-L1 expression were PD-L1
negative; 6 were evaluable for efficacy with 1 reporting tumour
shrinkage.
- Superior response rates to bemcentinib monotherapy in
relapsed/refractory (R/R) acute myeloid leukaemia (AML) and
myelodysplastic syndrome (MDS) could be predicted by soluble AXL
(plasma sAXL) levels as determined by liquid biopsy (study
BGBC003):
-
- 20 R/R AML and MDS patients who were evaluable for response
were analysed for pre-treatment plasma sAXL
-
- 12 of 13 patients reporting sAXL levels below pre-defined
thresholds at pre-treatment experienced clinical benefit,
including 3 Complete Remissions, 3 Partial Remissions.
- 6 of 7 patients with sAXL above the threshold experienced a
best response of progressive disease.
- Bemcentinib in combination with established first-line
therapies (KEYTRUDA or MEKINIST (dabrafenib) plus TAFINLAR
(trametinib) in unresectable melanoma was well tolerated and showed
encouraging tumour responses:
-
- 15 of 19 evaluable patients showed evidence of tumour shrinkage
and to date there were 2 CRs, 8 PRs and a further 6 patients with a
best overall response of stable disease.
- Blood-based biomarker candidates were identified.
- Bemcentinib in combination with targeted therapy TARCEVA®
(erlotinib) or docetaxel chemotherapy (trials BGBC004 and BGBIL005,
respectively) continue to show promising activity in heavily
pre-treated patients:
-
- Part C of the BGBC004 trial of bemcentinib in combination with
EGFR targeted therapy introduces bemcentinib in a first-line
setting in patients who have achieved their optimum benefit from
TARCEVA monotherapy. 5 of 6 evaluable patients showed evidence of
tumour shrinkage including 1 PR and 1 mixed response. In parts A
and B, patients who achieved an objective response continue on
treatment.
- 3 of 7 (43%) evaluable patients in a trial combining
bemcentinib and docetaxel (BGBIL005) achieved durable PRs in a
disease setting where the response rate to docetaxel monotherapy is
expected to be 10-20%.
- BerGenBio continues to develop a Bemcentinib companion
diagnostic
-
- A standardised AXL immunohistochemistry (IHC) assay, has
reported strong correlation with tumour response to bemcentinib
treatment.
- Blood-based biomarkers continue to report correlation with
tumour response to bemcentinib treatment with particularly
encouraging results in R/R AML and MDS.
Richard Godfrey, BerGenBio
CEO, commented: "We are excited to present these very
encouraging interim results from our broad Phase II clinical
development programme in a variety of tumour types with a
significant unmet medical need. These results continue to support
our view that bemcentinib could become a cornerstone of future
cancer therapy. This data provides further evidence of
bemcentinib's activity in patients whose cancer progression is
mediated by AXL. In addition, we are making good progress with our
studies to identify predictive biomarkers that we anticipate may be
developed as companion diagnostics for personalized therapy. We
look forward to advancing these studies to completion and defining
the future development strategy of bemcentinib with the greatest
value for patients."
Abstracts to be presented at ASCO
Monday 4 June, 8:00 AM - 11:30 AM Central
Daylight Time
- Interim data from BGBC008 – Poster Board: #292, Abstract
3078
- Interim data from BGBC003 – Poster Board: #80, Abstract
7020
-
- To be discussed at the Poster Discussion Session. 11:30 AM - 12:45 PM
- Biomarker study – Poster Board: #385, Abstract
2559
Monday 4 June, 1:15 PM –
4:45 PM CDT
- Interim data from BGBIL006 – Poster Board: #375, Abstract
9548
The posters presented at ASCO will be made
available www.bergenbio.com in the Investors /
Presentations section following the sessions.
Conference call
A conference call to discuss the presentations from the
reception and those to be presented at ASCO will take place on
Monday 4 June 2018 at 08:30 AM CEST. Details of the call are available
in the Investors section of the BerGenBio website
(www.bergenbio.com). A recording of the call will be available
shortly after the event at the same place. A presentation will be
available at www.bergenbio.com in the section:
Investors/Reports and presentations from 8:00 am CEST the same day.
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
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
This information is subject to the disclosure requirements
pursuant to section 5-12 of the Norwegian Securities Trading
Act.
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