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Biomarker predicts clinical benefit rate of 70% and overall response rate of 40% in second line NSCLC.

Melanoma combination study reports safety and efficacy.

Bergen, Norway, 22 October 2018 - BerGenBio ASA (OSE:BGBIO) announces that the company and its collaborators have presented interim clinical and biomarker data from BerGenBio’s Phase II clinical programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor, at the ESMO 2018 Congress in Munich (19 - 23 October 2018). Additionally, a pre-clinical study in myelodysplastic syndrome (MDS) was presented.

The posters are available at www.bergenbio.com in the Investors / Presentations section and a summary of results is given below.

(1) Poster Discussion: Predictive and Pharmacodynamic Biomarkers Associated with Phase II, selective and orally bioavailable AXL Inhibitor Bemcentinib Across Multiple Clinical Trials, Robert Holt et al

The poster discussed the broad biomarker programme run in parallel to the Phase II clinical trial programme with bemcentinib and detailed some of the key findings to date:

Tumour AXL expression predicts patient benefit: 7 out of 10 second line NSCLC patients showed clinical benefit (70% CBR) including 4 responses (40% ORR) on KEYTRUDA/bemcentinib combination therapy (determined by BerGenBio’s proprietary immunohistochemistry method).
Blood based biomarkers, including soluble AXL, have been found predictive of patient benefit in relapsed/refractory AML/MDS & NSCLC.

(2) Poster Presentation: Update on the randomised Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma, Cornelia Schuster et al

The poster gave an update on the randomised trial in first line metastatic melanoma, combining bemcentinib with standard of care therapies:

Confirmed recommended Phase II dose of bemcentinib in combination with MEKINIST/TAFINLAR and KEYTRUDA.
All combinations continue to be well tolerated.
Efficacy is seen across all arms with 18 out of 23 radiographically evaluated patients reporting clinical benefit including complete responses.

(3) Poster Discussion: The identification of the AXL/Gas6 signalling axis as a key player of myelodysplastic syndrome (MDS) and the potential of the oral selective AXL inhibitor bemcentinib in the treatment of MDS, Hind Medyouf et al

The poster discussed the relationship between AXL and myelodysplastic syndrome using both patient samples and animal model studies. The data show that AXL is upregulated in MDS patients and that inhibiting AXL with bemcentinib shows efficacy in pre-clinical models of the disease.

Richard Godfrey, CEO of BerGenBio, commented: The ability to predict which patients are most likely to derive benefit from treatment is an important competitive advantage as it is key to improving patient outcomes and regulatory success. The data presented at ESMO increases our confidence in the predictive nature of our proprietary biomarkers and diagnostics. What is more, 7 out of 10 AXL positive NSCLC patients showed clinical benefit in our phase II trial combining bemcentinib with KEYTRUDA, this is a remarkable observation and gives us confidence in bemcentinib’s proposed mechanism of action. Additionally, data presented at ESMO continue to show that bemcentinib is well tolerated and effective across our broad Phase II combination programme. We are looking forward to provide further updates on the development of our AXL inhibitor pipeline over the coming months.