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New Data on ASLAN003 Presented at Ash Annual Meeting Shows First Signs of Clinical Activity of a DHODH Inhibitor in Acute Myeloid Leukaemia
ASLAN003 is an orally active, potent inhibitor of dihydroorotate dehydrogenase (DHODH) that has the potential to be first-in-class in AML. As of
ASLAN003 has been well tolerated in patients treated to date. The most commonly occurring related adverse events were leukocytosis, nausea and rash, with grade 3 / 4 leukocytosis in 1 patient. The study contains 4 cohorts for the optimum dose determination (100 mg, 200 mg QD, and 100 mg, 200 mg BID with planned enrolment of 6 patients for each cohort), and an additional expansion cohort with the selected optimum dose (20 patients).
AML is a rapidly progressing blood cancer that is characterised by the uncontrolled proliferation of immature blast cells in the bone marrow. The five-year cancer survival rate for AML patients is 26.9%1. The majority of AML patients relapse or present with refractory disease and have overall poor prognosis2.
The primary outcome of the phase 2a study is to determine the optimum monotherapy dose of ASLAN003 and provide a preliminary estimate of efficacy evaluated by overall complete remission rate (OCRR). A phase 1 trial showed that ASLAN003 demonstrated dose proportional pharmacokinetics and was safe and well tolerated in healthy volunteers compared to the side effect profiles of existing AML induction and maintenance chemotherapies. ASLAN003 has demonstrated potent inhibition of DHODH (up to two orders of magnitude stronger than first generation DHODH inhibitors), lack of toxicities associated with first generation inhibitors and other novel AML therapies, and the potential to induce differentiation in blast cells and applicability in a broad range of AML patients.
ASLAN will also present new data from a preclinical study evaluating the effects of ASLAN003 on cell growth, differentiation, apoptosis, and gene expression changes in AML cell lines and primary bone marrow cells from patients with AML.
Posters presented at ASH:
Poster Number: 2676
Poster Number: 4047
Copies of the posters presented at ASH will be available to download from the Publications section of ASLAN’s website.
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Source: ASLAN Pharmaceuticals Limited