Aptose Biosciences’ tuspetinib boosted response rates when used in combination with standard of care (SoC) in a Phase I/II trial in acute myeloid leukaemia (AML).
The oral Myeloid Kinome Inhibitor (MKI) is being investigated in the TUSCANY trial (NCT03850574). When tuspetinib (TUS) was used in combination with venetoclax (VEN) and azacitidine (AZA), there was a 90% complete response (CR) rate across all AML patients compared with 65% in VEN and AZA alone.
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The rate was even higher (100%) in patients who are NPM1-mutant, FLT3-ITD and TP53-mutant.
The measurable residual disease (MRD) negativity rate in patients treated with the combination was 70% compared to 27.9% in SoC, with MRD-negativity and remissions continuing to mature over time. Amongst those who achieved CR, MRD was 78% in those who received TUS triple therapy compared to 40.9% of AML patients treated with SoC.
This data comes from three dosing levels, 40mg, 80mg and 120mg, with Aptose set to start dosing a cohort with 160mg. This comes as no significant safety concerns or dose-limiting toxicities (DLTs) have been observed in TUSCANY to date.
Aptose CEO Dr William Rice said: “We already have data from three different TUS dose levels in the TUSCANY trial, and the data continue to strengthen at higher doses of TUS and over time. We are building a strong case for TUS+VEN+AZA as a triplet frontline therapy of choice to address a broad AML population, including subgroups with the most adverse of mutations.”
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By GlobalDataAptose’s stock rose slightly on the data release, from a 15 August market close of C$1.72 to an 18 August open of C$1.86 – an 8% rise. The Canada-based biotech has a market cap of C$18m.
GlobalData forecasts sales of the drug will reach $18m in 2031. GlobalData is the parent company of Clinical Trials Arena.
AML market set to grow
The AML market is forecast to grow to $3.7bn in 2032 across the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China), according to GlobalData. The US market will remain the dominant AML market with approximately 66% of the 8MM market share.
There are several unmet needs in AML, especially in patients who experience relapse or do not achieve remission after initial treatment. Current therapeutic options are even more limited for AML patients with relapses. One therapy that has shown promise is SELLAS CDK9 inhibitor SLS009, which “exceeded expectations” in a Phase Ia/II trial in relapsed/refractory AML.
