On June 15, 2026 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company, reported that data from its Phase 1/2 TUSCANY trial in newly diagnosed AML patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) was presented yesterday in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2026) in Stockholm, Sweden.
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The TUS+VEN+AZA triplet is being developed as a mutation agnostic frontline therapy to treat large, mutationally unrestricted and diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Nikolai Podoltsev, MD, PhD, Associate Professor Medical Oncology & Hematology, Clinical Director, Malignant Hematology, Yale School of Medicine, and an investigator in the TUSCANY study, reported updated safety and efficacy data from the 80 mg and 120 mg dose cohorts, as well as new data from the 160 mg dose of TUS in the TUS+VEN+AZA triplet.
"While there have been recent successes with targeted therapy in AML treatment, our multi-targeted approach with tuspetinib in combination is showing significant efficacy across mutations that have been historically difficult to treat, including TP53 mutations, where we thus far have achieved CRs in all of the four subjects at the highest dose cohort," said Rafael Bejar, MD, PhD, Chief Medical Officer, Aptose. "As a safe and effective inhibitor of multiple growth factor signaling pathways, the TUS+VEN+AZA triplet is a first line combination therapy with the potential to improve outcomes in nearly all AML populations."
The oral presentation at EHA (Free EHA Whitepaper) included updated safety, complete remission, minimal residual disease (MRD) assessments, and longer duration of follow-up:
Presentation title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy
Presenter: Nikolai Podoltsev, MD, PhD, Associate Professor (Medical Oncology & Hematology), Department of Internal Medicine; Clinical Director, Malignant Hematology, Associate Program Director, Hematology / Medical Oncology Fellowship Program, Yale School of Medicine
Key findings:
32 (29 response evaluable), newly diagnosed AML patients have received the TUS+VEN+AZA combination:
4 received the 40 mg dose of TUS, 12 received the 80 mg dose of TUS, 3 received the 120 mg dose of TUS, and 13 received the 160 mg dose
The overall CRc rate across dose levels in response evaluable (29) patients was 86.2%.
The MRD negative rate among all patients dosed was 62.5%; MRD negative rate in CR/CRh patients was 86.2%.
At the 160 mg TUS dose level (n=13):
The overall CRc rate was 76.9% (10 of 13 patients), including 8 of 11 (72.7%) with unmutated (or wildtype) FLT3
100 % composite complete remission in all 4 patients with TP53-mutation with complex karyotype (TP53-mut/CK)
Regardless of mutation status, TUS is active in newly diagnosed AML patients
MRD-negative responses achieved across diverse genetic populations, including adverse TP53 mutations and CK
Responses continue to evolve with 19 subjects remaining on treatment, including 6 that moved on to stem cell transplantation
TUS can be administered safely with standard-of-care dosing of VEN/AZA
TUS PK properties were not significantly altered by VEN, AZA, antifungals or food
No treatment-related deaths
No treatment-related adverse events of QTc prolongation, CPK elevations or differentiation syndrome
Abstracts are available on the EHA (Free EHA Whitepaper)2026 website here. The presentation is available on the Aptose website here.
TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study
The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 clinical study with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes.
The TUSCANY Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS, is being administered in 28-day cycles.
More information on the TUSCANY Phase 1/2 study can be found on www.clinicaltrials.gov (here).
(Press release, Aptose Biosciences, JUN 15, 2026, View Source [SID1234668735])