BerGenBio extends Phase II trial with bemcentinib and KEYTRUDA® in NSCLC to include patients with disease progression on immune checkpoint inhibitor therapy

• First patient dosed in new cohort of Phase II trial evaluating selective AXL inhibitor bemcentinib in combination with KEYTRUDA in patients with advanced NSCLC whose disease is progressing on anti-PD(L)1 therapy
• New cohort added under existing collaborative agreement with Merck assessing the combination in previously treated advanced NSCLC
• Decision to extend driven by encouraging preclinical data and high unmet need for treatment options after anti-PD(L)1 failure

Bergen, Norway, 2 April 2019 – BerGenBio ASA (OSE: BGBIO) announces that the first patient has been dosed in an additional cohort (“Cohort B”) of an ongoing phase II open-label study of BerGenBio’s selective AXL inhibitor bemcentinib in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in previously treated patients with advanced adenocarcinoma of the lung (NSCLC).

The additional cohort of the BGBC008 trial, being run in collaboration with Merck (known as MSD outside the US and Canada), will extend eligibility to include patients with previously treated advanced NSCLC whose disease is progressing on immunotherapy.

Patients eligible to participate in Cohort B must have disease progression whilst on a therapy regimen which includes an anti-PD(L)1 inhibitor. The trial follows a two-stage design with the opportunity for an early stop for futility and will evaluate the combination’s objective response rate as a primary endpoint. Comprehensive exploratory studies will evaluate biomarkers in tumour and blood indicative of AXL and PD-L1 expression as well as immune modulation.

Preliminary results from Cohort B are expected in H2 2019. BerGenBio is responsible for conducting the trial. Merck will supply KEYTRUDA for use in the study under a collaboration agreement signed in March 2017.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “Throughout 2018, we reported encouraging updates from our ongoing proof-of-concept Phase II clinical trial assessing bemcentinib in combination with KEYTRUDA in advanced lung cancer patients post chemotherapy. Patients with AXL positive disease showed particularly good response rates, supporting our belief that selectively inhibiting AXL may act synergistically with immune checkpoint inhibitors in immunotherapy naïve patients. Pre-clinical and translational data strongly suggest that AXL is implicated in anti-PD(L)-1 (checkpoint-inhibitor) therapy failure which has become a large unmet medical need following the rapid uptake of checkpoint inhibitors in first-line lung cancer therapy. Therefore, I am pleased that we are now extending the ongoing trial to test our hypothesis also in patients showing disease progression on checkpoint inhibitors and I look forward to providing updates on both cohorts during 2019.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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About NSCLC

It is estimated that more than 230,000 new cases of lung cancer have been 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 open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated patients with advanced adenocarcinoma of the lung run at centres in the US, UK, Spain and Norway. 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).

Patients eligible for participation in Cohort A must have progressed on or after prior therapy excluding immunotherapy whereas patients in Cohort B will be actively progressing on a therapy regimen containing an anti-PD(L)-1 therapy.

Both cohorts follow a two-stage design, Cohort A has previously successfully progressed into the second stage after meeting its first efficacy endpoint. Cohort B will evaluate advancement into stage 2 after 13 patients have been assessed for response.

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 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

Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Carina Jurs, Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

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.