On May 15, 2019 BerGenBio ASA (OSE: BGBIO) a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, notes the publication of abstracts relating to new interim clinical and biomarker data that the company and its collaborators reported that it will present from its extensive Phase II clinical development programme with bemcentinib at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) at McCormick Place in Chicago, Illinois (31 May – 4 June 2019) (Press release, BerGenBio, MAY 15, 2019, View Source [SID1234536362]).
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The abstracts have been made available online at abstracts.asco.org today and details of the presentations are below.
The posters presented at ASCO (Free ASCO Whitepaper) will be made available at www.bergenbio.com in the Investors / Presentations section to coincide with the following conference sessions:
Sunday 2 June, 8:00 AM – 11:30 AM Central Daylight Time
A Phase II study of bemcentinib (BGB324), a first-in-class highly selective AXL inhibitor, with pembrolizumab in patients with advanced NSCLC: OS for stage I and preliminary stage II efficacy.
Enriqueta Felip et al
Session: Lung Cancer – Non-Small Cell Metastatic
Location: Hall A, poster board #421, abstract 9098
Data highlights:
Phase II clinical trial assessing bemcentinib in combination with pembrolizumab (KEYTRUDA) in advanced lung cancer patients post chemotherapy.
The combination treatment of bemcentinib and pembrolizumab was overall well-tolerated.
Promising clinical activity continues to be seen overall, particularly in patients with AXL positive tumours including those with weak or no PD-L1 expression.
Updated results will be reported at the meeting, including the 12-month overall survival for stage 1 and preliminary efficacy of Stage 2.
Monday 3 June, 8:00 AM – 11:30 AM Central Daylight Time
First-in class selective AXL inhibitor bemcentinib (BGB324) in combination with low dose AraC (LDAC) or decitabine exerts anti-leukaemia activity in AML pts unfit for intensive chemotherapy: Phase II open-label study.
Dr Sonja Loges et al
Session: Hematologic Malignancies – Leukaemia, Myelodysplastic Syndromes, and Allotransplant
Location: Hall A, poster board #418, abstract 7043
Data highlights:
Bemcentinib in combination with LDAC exerted early onset and durable responses in patients with both de novo and relapsed AML, whilst the combination of bemcentinib and decitabine exerted comparably fewer and later responses in de novo AML.
Both combinations were generally well-tolerated.
Updated results will be presented.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are encouraged by the promising data that continues to emerge from our clinical development programme with bemcentinib in AML and NSCLC. Following the data that was gathered in January, we have expanded our clinical programmes in both indications and, together with our investigators, look forward to providing further important findings at ASCO (Free ASCO Whitepaper).
"Most NSCLC patients in Europe now receive anti-PD(L)-1 therapies like KEYTRUDA as a first- or second-line treatment for their advanced disease. Improving responses to these novel agents, particularly in patients with no or limited expression of PD-L1, who may not have benefitted from such therapies, is significant. Similarly, positive responses in a less fit AML patient population considered to have unfavourable prognosis after the failure of first-line therapies, or those with high risk cytogenetics is very encouraging."