Late breaking abstract at SITC: Analysis of first stage of
phase II trial with selective AXL inhibitor bemcentinib + KEYTRUDA
in previously treated advanced NSCLC patients
Median progression-free-survival (mPFS) of 5.9 months in AXL
positive vs 3.3 months in AXL negative patients (~80%
improvement)
Predominantly PD-L1 negative or weak-positive patient
population
BERGEN, Norway, Nov.
6, 2018 /PRNewswire/ - BerGenBio ASA (OSE: BGBIO) announces
that a Late-breaking Abstract detailing median
progression-free-survival (mPFS) during the first stage of its
phase II clinical trial with bemcentinib, a first-in-class
selective oral AXL inhibitor, in combination with the anti-PD-1
therapy KEYTRUDA® (pembrolizumab) in patients with previously
treated, advanced non-small cell lung cancer (NSCLC) has been
published today and will be presented at the annual Society for
Immunotherapy in Cancer (SITC) 2018 congress in Washington D.C. (7-10
November 2018).
24 patients have been enrolled during the first stage of the
combination trial. The median time that patients lived without
progression of their disease (mPFS) was 5.9 months in AXL positive
patients (n=10) and thus greater than the mPFS of 3.3 months in
patients whose tumours did not show any AXL expression as per
BerGenBio's proprietary biomarker test (n=11). mPFS is an
outcome criterion that measures the time that patients can stay on
treatment in the trial without their disease getting worse.
The full abstract is available
at https://www.sitcancer.org/2018/abstracts and a poster
will be presented by the study's lead investigator at the SITC
congress in Washington DC on
Friday, 9 November 2018.
Richard Godfrey, Chief
Executive Officer of BerGenBio,commented: "In addition to very
encouraging tumour response data previously reported, today we can
reveal for the first time the median progression-free survival
(mPFS) for patients on our phase II trial combining bemcentinib
with KEYTRUDA. We are excited to report in the late-breaking
abstract that patients with AXL-positive disease showed an almost
80 percent improvement in mPFS compared to AXL-negative patients.
Whilst the number of patients included in stage 1 of the trial
remains relatively small, we are very encouraged that mPFS of
almost six months in AXL-positive patients on the
bemcentinib/KEYTRUDA combination trial compares favourably to
historically reported PFS data from advanced NSCLC patients on
anti-PD-1 therapy, such as KEYTRUDA, alone (1, 2). Of note, PFS
during stage 1 of our trial was not driven by high PD-L1 expression
as the population studied was predominantly negative or only weakly
positive for the PD-L1 biomarker. This indicates that we would only
expect a limited benefit from KEYTRUDA monotherapy. Stage 2 of the
trial is actively recruiting and we look forward to further update
outcome data at future medical conferences."
Study Design and additional data from the Late-breaking
Abstract
A Phase II study of bemcentinib (BGB324), a first-in-class
selective AXL inhibitor, in combination with pembrolizumab in
patients with advanced NSCLC: Analysis of the first
stage (BerGenBio study reference: BGBC008)
- Category: 33rd Annual Meeting Late-Breaking Abstracts
Presentation number: P715
- Friday 9 November, 12:45 - 2:15 p.m Eastern time, Hall E
The BGBC008 study is investigating whether adding bemcentinib to
KEYTRUDA (pembrolizumab) in previously treated, PD-L1 unselected
and immunotherapy naive patients with advanced adenocarcinoma of
the lung is well tolerated and improves patient outcomes. A total
of 48 patients across two stages will be enrolled.
- The first stage is fully enrolled with 24 patients, of which 5
patients remain on treatment or in follow-up; the second stage is
open and enrolling
- The biomarker analysis revealed that:
- 10 of 21 evaluable patients were AXL positive (48%)
- Of 21 patients evaluated for PD-L1 expression, 11 (46%) were
PD-L1 negative (<1%); 7 (29%) were weakly positive (1-49%) and 2
(8%) were strongly positive (>50%)
- 40% overall response rate (ORR) was reported in AXL-positive
patients with a disease control rate (DCR) of 70%, compared with 9%
ORR (45% DCR) for AXL-negative patients
- Median progression-free survival was 5.9 months in AXL-positive
patients, compared to 3.3 months in AXL-negative patients
|
Overall (n =
24)
|
AXL positive
(n = 10)
|
AXL negative (n =
11)
|
Antitumour
activity
|
Best
overall response, n (%)
|
PR
|
5 (21)
|
4 (40)
|
1 (9)
|
SD
|
8 (33)
|
3 (30)
|
4 (36)
|
PD
|
10 (42)
|
3 (30)
|
5 (45)
|
Disease
control, n (%)
|
13 (54)
|
7 (70)
|
5 (45)
|
median PFS, months
(95% CI)
|
4.0 (2.0 -
NR)
|
5.9 (1.7 -
NR)
|
3.3 (1.2 -
NR)
|
- PR: partial response, SD: stable disease, PD:
progressive disease, PFS: progression-free-survival, CI: confidence
interval, NR: not reached
- One AXL negative patient withdrew from study
before any response assessment could be made.
|
An update from BerGenBio's biomarker and companion diagnostic
programme will also be presented as a poster within the regular
abstract section at SITC on Nov 9th.
Both presentations will be made available on the BerGenBio website
in the Investors / Presentations section on the day of
presentation.
About SITC
The Society for Immunotherapy of Cancer (SITC) is the world's
leading member-driven organisation specifically dedicated to
improving cancer patient outcomes by advancing the science and
application of cancer immunotherapy. Over 4,000 delegates are
expected to attend the SITC 33rd Annual Congress in Washington D.C. on Nov
7-10 2018. For more information, please
see www.sitcancer.org
Late-breaking abstracts highlight novel and potentially
practice-changing studies, and their acceptance for presentation is
subject to favourable assessment by a panel of clinical and
scientific experts. In total, only 21 abstracts were accepted in
the late-breaking category at this year's SITC congress:
https://sitc.sitcancer.org/2018/abstracts/titles/late-breaking/
About the BGBC008 trial
A Phase II study of bemcentinib in combination with
pembrolizumab in patients with previously treated advanced
NSCLC
The BGBC008 trial is a phase II multi-centre open-label study of
bemcentinib in combination with KEYTRUDA (pembrolizumab) in
previously treated, immunotherapy naive, 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. 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 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.
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 a 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
Richard Godfrey
CEO,
BerGenBio ASA
+47-917 86 304
Rune Skeie,
CFO,
BerGenBio ASA
rune.skeie@bergenbio.com
+47-917-86-513
International Media Relations
David Dible,
Mark Swallow,
Marine Perrier,
Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44-207-638-9571
Media Relations in Norway
Jan
Petter Stiff,
Crux Advisers
stiff@crux.no
+47-995-13-891
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.
References
(1) Borghaei et al NEJM (2015): Nivolumab vs
docetaxel in previously treated (1 prior line of Pt containing
chemotherapy) non-squamous NSCLC, any PD-L1. Reported 19% ORR and
mPFS of 2.3 months for nivolumab monotherapy irrespective of PD-L1
status.
(2) Garon et al NEJM (2015): Pembrolizumab vs
docetaxel in previously treated (at least 1 prior line of Pt
containing chemotherapy) NSCLC. Reported mPFS of 3 months for
pembrolizumab monotherapy irrespective of PD-L1 status.
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