On September 27, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported to provide study updates in two poster presentations from its Phase II clinical development programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, in Barcelona (27 September – 01 October 2019) (Press release, BerGenBio, SEP 27, 2019, View Source [SID1234539852]).

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The first poster outlines data from BerGenBio’s Phase II clinical trial (BGB008) with bemcentinib and Merck’s anti-PD-1 therapy pembrolizumab (KEYTRUDA) in patients with advanced non-small cell lung cancer (NSCLC). Data shows that the combination is well tolerated and showed promising efficacy in previously treated NSCLC patients, particularly in those with AXL expression in tumour, immune and stromal cells, including PDL-1 low/negative patients. The poster also highlights the identification of a new novel predictive plasma protein biomarker.

The second poster provides a trial update on a randomized Phase Ib/II study of bemcentinib in combination with either dabrafenib/trametinib (D/T) or pembrolizumab in patients with metastatic melanoma. Data from the trial shows that bemcentinib is well tolerated in combination with both D/T and pembrolizumab, with adverse effect profiles consistent with those reported for either therapeutic approach alone.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "AXL mediates aggressive traits when expressed on tumour, immune and stromal cells in cancers. Bemcentinib inhibits this, and we see encouraging and very durable clinical benefit in patients who otherwise would not be expected to respond to PD-1 inhibitors. Our comprehensive translational research program is yielding novel biomarkers and validation of the mode of action of bemcentinib. We look forward to providing updates as data from our ongoing investigations becomes available."

Presentation details
Full abstracts are available online at View Source -Congress-2019/Abstracts and details of the presentations are below. The posters presented at ESMO (Free ESMO Whitepaper) will be made available at www.bergenbio.com in the Investors / Presentations section following the sessions.

Preliminary efficacy results of selective AXL inhibitor bemcentinib with pembrolizumab following chemo in patients with NSCLC (ID 2041)

Jose M. Trigo Perez et al
1576P – Poster Display session 1
28 September 2019: Poster Area (Hall 4), 12:00 – 13:00
Trial update: A randomized Phase Ib/II study of the selective small molecule Axl inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib (D/T) or pembrolizumab in patients with metastatic melanoma (ID 2131)

Oddbjørn Straume et al
1336P – Poster Display session 3
30 September 2019: Poster Area (Hall 4), 12:00 – 13:00
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About AXL
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.

About bemcentinib
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.