BERGEN from Norway, June 11, 2021 / PRNewswire / – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel selective AXL kinase inhibitors for serious unmet medical need, to present updated preliminary study survival data ongoing phase II bemcentinib (BGBC003) in combination with low dose cytarabine (LDAC) in elderly patients with relapsing acute myeloid leukemia (AML) at the European Hematology Association (EHA) 2021 virtual meeting June 9-17, 2021.
An update will be provided from an expansion cohort of 27 patients with relapsed / refractory AML, who were evaluated to explore safety and efficacy as well as a translational analysis.
The data indicate that the combination of bemcentinib, a once daily oral AXL inhibitor, and LDAC is effective and well tolerated in the elderly and unfit for the relapsing AML population. Durable responses have been observed in relapsed AML, with an overall response rate of 31% (5/16) and a median overall survival of 13.3 months, currently still immature and potentially subject to change.
In a subset of eleven patients with relapsed AML who received at least two cycles of the combination, increased clinical benefit was demonstrated; a CR / RCi rate of 36% (4/11) was observed, associated with an encouraging overall survival to date (median OS not reached at> 16 months) with several subjects continuing the study. In contrast, historical controls for LDAC monotherapy suggest CR / RCi rates of 13 to 17% with median survival rates of 4.1 to 5.6 months, as reported by Sarkozy et al. (2015) and Wei et al. (2020).
An in-depth translational research program aimed at identifying molecular and biological predictive factors associated with the response is underway.
Ongoing dialogue continues with FDA and EMA regulatory agencies to align on path for pivotal registration trial for combination of bemcentinib and LDAC in elderly patients with AML relapsing and unfit for intensive chemotherapy.
Dr. Sonja Lodges, principal investigator of the trial, commented: “We were impressed to see these positive responses in patients with relapsed AML, for whom treatment options are very limited under the current standard of care. Interestingly, the first complete responses were reported at a relatively late stage of the trial, between week 13 and week 15. These late-onset responses may reflect the importance of AXL mechanisms in the development of disease and the potential benefits of immune therapy from treatment with bemcentinib. Further clinical study of this promising combination is therefore warranted. “
Richard godfrey, CEO of BerGenBio, commented: “We are very encouraged by this promising preliminary response and the survival data from the combination of bemcentinib and LDAC in this patient population. Effective treatments with significant survival benefit for patients with relapsed AML are recognized as a critical unmet medical need, which is a significant and rapidly growing population of patients as treatment options become available first. intention improve. Europe and the United States to align itself on the path forward to embark on a pivotal late-stage trial of bemcentinib in this combination and patient population. “
Electronic poster presentations can now be viewed online for registered participants here: https://ehaweb.org/congress/eha-congress-2021/program/featured-sessions/.
Details of the electronic poster layout are below.
Title of electronic poster: THE COMBINATION OF BEMCENTINIB, AXL INHIBITOR AND LOW-DOSE CYTARABINE IS WELL TOLERATED AND EFFECTIVE IN OLDER RELAPSE AML PATIENTS: UPDATE OF THE BGBC003 PHASE II TRIAL IN PROGRESS (NCT02488408)
Abstract number: EHA-2859
Session: 04. Acute myeloid leukemia – Clinical
Date hour : Available from 9 a.m. CEST June 11
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases.
In COVID-19, AXL has two synergistic mechanisms of action, it acts as an ACE2 co-receptor, to which the SARS-CoV-2 virus spike protein binds and enters the host cell, and the AXL expression is upregulated, which leads to suppression of the type 1 interferon immune response by host cells and in their environment.
Research data confirms that bemcentinib inhibits entry into the host cell of SARS-CoV-2 and promotes the antiviral response to type I interferon. Data from a phase II clinical trial in humans showed that treatment with the AXL inhibitor, bemcentinib, increased the rate of ventilator-free survival in hospitalized COVID-19 patients.
In cancer, increased expression of AXL has been linked to key mechanisms of drug resistance and immune escape by tumor cells, leading to aggressive metastatic cancers. AXL suppresses the body’s immune response to tumors and causes treatment failure in many cancers. Elevated AXL expression defines a subgroup of very poor prognosis in most cancers. AXL inhibitors, such as bemcentinib, therefore have high potential value as monotherapy and as a cornerstone of combination therapy against cancer, addressing important unmet medical needs and multiple opportunities. high value market. Research has also shown that AXL mediates other aggressive diseases, including fibrosis.
Bemcentinib (formerly known as BGB324) is a potent, highly selective, first-class potential inhibitor of AXL currently in a large phase II clinical development program. It is administered as an oral capsule and taken once a day. Ongoing clinical trials are studying bemcentinib in COVID-19 and multiple solid and hematologic tumors, 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 the AXL receptor tyrosine kinase and inhibits its activity.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on the development of transformative drugs targeting AXL as a potential cornerstone for the treatment of aggressive diseases, including therapy-resistant and immuno-evasive cancers. The Company’s principal candidate and owner, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a large phase II clinical development program focused on combination and single agent therapy in cancer, leukemia and COVID-19. A first functional anti-AXL blocking antibody, tilvestamab, is undergoing a phase I clinical trial. In parallel, BerGenBio is developing a companion diagnostic test to identify the patient populations most likely to benefit from the inhibition of AXL: This should facilitate more efficient registration trials supporting a marketing strategy based on precision medicine.
BerGenBio is based at Bergen, Norway with a subsidiary at Oxford, United Kingdom. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visit www.bergenbio.com
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