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Bergen, Norway, 8 September 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, will present study updates from its Phase II clinical development programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor, in non-small cell lung cancer (NSCLC) at the 2019 World Conference on Lung Cancer (WCLC) in Barcelona, Spain (07 - 10 September 2019).
The two presentations will outline BerGenBio's Phase II clinical trial (BGB008, NCT03184571) with bemcentinib and Merck's anti-PD-1 therapy pembrolizumab (KEYTRUDA) in patients with advanced non-small cell lung cancer (NSCLC).
Data will be presented at a mini oral session entitled: Efficacy Results of Selective AXL Inhibitor Bemcentinib with Pembrolizumab Following Chemotherapy in Patients with NSCLC. As announced in June 2019, the preliminary results from the ongoing study showed promising clinical activity overall, particularly in patients with AXL positive tumours, including those with low or no PD-L1 expression. Preliminary median overall survival has reported 12.2 months, surpassing historical benchmarks in second-line treatment with PD-1 inhibitor monotherapy, especially in low PD-L1 patients; and the combination treatment was well-tolerated.
The Company will also present details of a second cohort of the Phase II trial (BGB008, NCT03184571) at a poster session, entitled: A Phase II Study of Selective AXL Inhibitor Bemcentinib and Pembrolizumab in Patients with NSCLC Refractory to Anti-PD(L)1. The trial has been expanded to include patients that have been previously treated with a PD-(L)1 inhibitor, or a PD-(L)1 inhibitor in combination with platinum containing chemotherapy and will further evaluate the clinical activity and safety profile of the combination.
Full abstracts are available online at https://wclc2019.iaslc.org. Materials presented at WCLC will be made available at www.bergenbio.com in the Investors / Presentations section following the sessions.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "As we continue to gather data in refractory NSCLC patients, we hope to build up a clearer picture of the potential of bemcentinib in combination with pembrolizumab. Our focus remains on enhancing responses to anti-PD-L1 therapies, particularly in patients with no or limited expression of PD-L1, who may not have benefitted from such therapies. Results to date have been encouraging, and we look forward to providing updates as further data becomes available."
BGBC008, which began in October 2017, is being conducted under a clinical collaboration with Merck & Co., Inc., Kenilworth, N.J., USA, through a subsidiary, and is taking place at sites in the US, UK, Norway and Spain.
Presentation detailsEfficacy Results of Selective AXL Inhibitor Bemcentinib with Pembrolizumab Following Chemotherapy in Patients with NSCLC
- Enriqueta Felip et al
- #MA03.06 - Clinomics and Genomics
- Mini Oral Session
- 08 September 2019: Colorado Springs (1994), 11:05 - 11:10am CEST
- Matthew Krebs et al
- #P1.01-83 - Advanced NSCLC
- Poster Viewing in the Exhibit Hall
- 08 September 2019: Exhibit Hall, 09:45am CEST
- END -
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body's immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.
Bemcentinib (formerly known as BGB324), 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. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers. The company's proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II oncology clinical development programme focused on combination and single agent therapy in lung cancer and leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL-ADC (ADCT-601) are undergoing phase I clinical testing. In parallel, BerGenBio is developing a companion diagnostic test to identify those patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting 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
+47 917 86 513
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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.