[PDF] Extrait 5 ( PDF 1 539 Ko)

What is ko-539 (komet-001)?

KO-539, a potent and selective menin inhibitor, is currently in a Phase 1b clinical trial (KOMET-001) for patients with relapsed/refractory AML, including patients with NPM1 mutations or KMT2A rearrangements.

Can patients enrolled in the Phase 1b study continue to receive ko-539?

Patients currently enrolled in the Phase 1b study may continue to receive KO-539, although no additional patients may be enrolled until the partial clinical hold is resolved. Kura is working closely with the FDA and the site investigators to resolve the partial clinical hold as quickly as possible.

Is ko-539 dose-dependent?

Treatment with KO-539 dose-dependently inhibited in vitro growth, as well as induced differentiation (by both morphology and increased CD11b expression) and loss of viability of MOLM13 (MLL-AF9 and FLT3-ITD) and OCI-AML3 (NPM1c and homozygous NRAS mutation) cells and patient-derived (PD) MLL-r or NPM1c AML cells.

Does ko-539 induce differentiation and loss of viability in AML cells?

Preclinical data show that KO-539 and close analogs induce differentiation and loss of viability of AML cells, and exert profound anti-leukemic activity in multiple PDX models harboring MLL-FP or NPM1c when dosed continuously QD for 3-6 weeks.