BerGenBio reports ~80% improvement in PFS of AXL-positive vs AXL-negative NSCLC patients in bemcentinib + KEYTRUDA PhII combination tria
· 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, 6 November 2018 - 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)
· Matthew Krebs, PhD et al
· 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 AXL AXL negative (n = 11)
(n = 24) positive (n
= 10)
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 13 (54) 7 (70) 5 (45)
control, n
(%)
median PFS, 4.0 (2.0 5.9 (1.7 - 3.3 (1.2 - NR)
months (95% - NR) NR)
CI)
· 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 (https://www.bergenbio.com/investors/presentations/) section on
the day of presentation.
- END -
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
Contacts
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 pembrolizu
