On September 8, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported that it 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) (Press release, BerGenBio, SEP 8, 2019, View Source [SID1234539361]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 View Source 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 details
Efficacy 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
A Phase II Study of Selective AXL Inhibitor Bemcentinib and Pembrolizumab in Patients with NSCLC Refractory to Anti-PD(L)1

Matthew Krebs et al
#P1.01-83 – Advanced NSCLC
Poster Viewing in the Exhibit Hall
08 September 2019: Exhibit Hall, 09:45am CEST
– END –

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.