- Combination of selective AXL inhibitor bemcentinib and KEYTRUDA® featured in late breaking abstract at leading I0 conference SITC
- Analysis comprises stage 1 (n=24) in PhII trial in 2L advanced NSCLC
- Stage 2 open and enrolling
Bergen, Norway, 2 November 2018 – BerGenBio ASA (OSE:BGBIO) announces that the analysis of 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 selected as a Late-breaking Abstract at the annual Society for Immunotherapy in Cancer (SITC) 2018 congress in Washington D.C. (7-10 November 2018).
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/
An update from BerGenBio’s biomarker and companion diagnostic programme will also be presented as a poster within the regular abstract section. See details below.
Presentations at SITC:
Friday 9 November, 12:45 – 2:15 p.m. and 6:30 – 8 p.m. EST, Hall E
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
- Matthew Krebs, PhD, et al
- Category: 33rd Annual Meeting Late-Breaking Abstracts
- Presentation number: P715
- Robert Holt, PhD, et al
- Category: Biomarkers and Immune Monitoring
- Presentation number: P115
Predictive and pharmacodynamic biomarkers associated with treatment with the oral selective AXL Inhibitor bemcentinib in combination with pembrolizumab in patients with advanced NSCLC and Melanoma
The full abstracts will be published on November 6th at 8 a.m. Eastern time at https://www.sitcancer.org/2018/home.
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
About BerGenBio’s Companion Diagnostics programme
In parallel with its phase II clinical trial programme, BerGenBio explores predictive biomarker candidates with the aim to develop a companion diagnostic to identify patients most likely to benefit from bemcentinib treatment.
Thus far, the company reported strong correlation with response of both plasma soluble AXL levels and the presence of tissue AXL in relapsed/refractory AML or MDS and advanced NSCLC, respectively.
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 na1ve, 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.
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
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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.