BerGenBio Reports ~80% Improvement in PFS of AXL-positive vs AXL-negative NSCLC Patients in Bemcentinib + KEYTRUDA PhII Combination Trial

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

News provided by

BerGenBio ASA

Nov 06, 2018, 08:38 ET

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)

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 (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
[email protected]
+47-917-86-513

International Media Relations
David Dible,
Mark Swallow,
Marine Perrier,
Citigate Dewe Rogerson
[email protected]
+44-207-638-9571

Media Relations in Norway
Jan Petter Stiff,
Crux Advisers
[email protected]
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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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SOURCE BerGenBio ASA