On June 3, 2019 BerGenBio ASA (OSE:BGBIO) reported data showing significant efficacy in Phase II clinical trials (BGBC003, NCT02488408) evaluating bemcentinib, a first-in-class selective oral AXL inhibitor, in combination with low-dose cytarabine (LDAC) or decitabine as a potential new treatment regimen for acute myeloid leukaemia (AML) patients unable to tolerate intensive therapy (Press release, BerGenBio, JUN 3, 2019, View Source [SID1234536799]). The data will be presented at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Chicago, Illinois (31 May – 4 June 2019).

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In total, 33 patients were enrolled into the trial: 16 into the LDAC + bemcentinib group, of which 13 are evaluable for efficacy to date, and 17 into the decitabine + bemcentinib group, of which 12 are evaluable for efficacy to date.

Among the 13 evaluable patients in the LDAC + bemcentinib group, 6 responses have been reported; 4 patients achieved complete remission / complete remission with incomplete hematologic recovery (CR/CRi) and 2 patients’ partial remission (PR). This yields an overall response rate (ORR) of 46%, including 31% CR/CRi among elderly AML patients (>70 years). Furthermore, one patient achieved durable stable disease for more than 3 months. The relapse free survival rate (RFS) for patients with CR/CRi is 6.2 months (0.7 to 9.6 months); data immature.

In the decitabine/bemcentinib group, of the 12 evaluable patients, 3 responses have been reported; 1 patient achieved CR/CRi and 2 patients PR. This yields an ORR of 25%. Furthermore, five patients had durable stable disease for more than 3 months. The RFS for patients with CR/CRi is 5 months; data immature.

The combination treatment of bemcentinib and LDAC or decitabine was overall well-tolerated; the most common adverse events (>15% of patients) included anaemia, neutropenia and diarrhoea. No grade 5 TRAEs were reported and all events were reversible.

Professor Sonja Loges, attending physician and principal investigator, University Medical Centre Hamburg Eppendorf, Germany commented: "These early results are very encouraging, particularly as we have seen responses in a less fit AML patient population with comparatively poor prognosis [having not responded to first-line therapies], or with high risk cytogenetics. These data show that bemcentinib in combination with LDAC resulted in a significantly higher ORR than previously observed/historical benchmarks in single-agent cytarabine. These early results warrant further investigation of bemcentinib in a larger trial addressing AML patients unfit for intensive chemotherapy."

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "A majority of AML patients are unable to tolerate intensive chemotherapy and have limited treatment options, particularly if established first-line therapies fail. These combination trials of bemcentinib with low-dose cytarabine and decitabine show promising results that the addition of our selective AXL inhibitor will improve the outcome of treatment with these much-used agents. Although these are early findings, we are encouraged by the emerging clinical data and focused on advancing our late stage development programme."

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About AML and the BGBC003 trial
Acute myeloid leukaemia (AML) is a rapidly progressing blood cancer. AML is the most common form of acute leukaemia in adults, where malignant AML blasts interfere with the normal functioning of the bone marrow leading to a multitude of complications like anaemia, infections and bleeding. AML is diagnosed in over 20,000 patients in the US annually and is rapidly lethal if left untreated. Successful treatment typically requires intensive therapy or bone marrow transplantation, and relapse and resistance are common. Consequently, there is an urgent need for effective novel therapies in relapsed/refractory patients, particularly those that are ineligible for intensive therapy or bone marrow transplant.

The BGBC003 trial is a phase Ib/II multi-centre open label study of bemcentinib in combination with cytarabine (part B2) and decitabine (part B3) in patients with AML who are unsuitable for intensive chemotherapy as a result of advanced age or existing-co-morbidities. Up to 28 patients will be enrolled at centres in the US, Norway, Germany and Italy.

For more information please access trial NCT02488408 at www.clinicaltrials.gov.

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.