Gilteritinib Versus Midostaurin in Patients With Newly Diagnosed FLT3-MUTATED Acute Myeloid Leukemia Eligible For Intensive Therapy: Results From The Phase 3 HOVON156/AMLSG28-18/PASHA Trial

Presenter: Dr. Marc Raaijmakers

• A phase 3 trial compared gilteritinib (120 mg od) with midostaurin (50 mg bid) in newly diagnosed FLT3^mut+ AML (n=768) on intensive chemotherapy.
• After a median follow‑up 43.2 months, primary endpoint of OS was similar with both (P=0.864) and was not met.
• EFS favored gilteritinib (51.1 vs 19.9 months; P=0.052).
• CR rates were similar; relapse rates were lower with gilteritinib (21% vs 36%, P=0.003).
• Serious AEs were higher with gilteritinib vs midostaurin (68% vs 59%).
• Clinically meaningful improved relapse outcomes did not translate into OS benefit.
• In relapsed patients, mOS was 7.2 mo (gilteritinib) vs 10.2 mo (midostaurin) (HR 1.54; P=0.022)
• 60-day mortality rates were 9% (gilteritinib) vs 6% (midostaurin).
• Survival outcomes for giltertinib were not significantly different from midostaurinin ND FLT3^mut+ AML, thus the primary endpoint was not met.

First-in-Class Switchable Allogeneic Car-T Therapy for CD123+ AML – Results from the Phase IA REVSTAR-123 (AVC-201-01) Study

Presenter: Martin Wermke

• This study evaluated a first-in-class switchable allogeneic CD123-directed CAR-T therapy in 17 heavily pretreated AML patients.
• The treatment demonstrated favorable safety, with no treatment-related mortality, neurotoxicity, or GvHD; one manageable dose-limiting toxicity (DLT) occurred.
• CRS was common but low grade (Grade 1–3).
• Robust CAR-T expansion, persistence, and reactivation with adapter cycles were observed.
• Anti-leukemic activity was promising, particularly at higher doses, with multiple complete responses, MRD conversions, and ongoing remissions.

  The switchable RevCAR platform enabled controlled CAR-T activation and deactivation, addressing safety concerns while maintaining efficacy.

• In Phase Ia, thisswitchable, allogeneicCAR-T showed favorable safety and tolerability without treatment-related mortality or neurotoxicity. RevSTAR-123 has now advanced into Phase Ib, enrolling 20 R/R AML patients at DL15.

Replacement of High Dose Combination Chemotherapy With Blinatumomab in Newly Diagnosed Pediatric High-Risk B-Cell All Improves Efficacy and Safety In The Randomized Phase 3 AIEOP-BFM ALL 2017 Trial

Presenter: Martin Schrappe

• AIEOP-BFM ALL 2017 randomized phase 3 trial evaluated replacing two high-dose chemotherapy blocks with blinatumomab in newly diagnosed pediatric high-risk B‑ ALL.

• Among 709 randomized patients, blinatumomab significantly improved 4-yr EFS to 83% versus 70.3% with chemotherapy (HR 0.51), reduced relapse (11.8% vs 21.4%) and markedly lowered isolated CNS relapse.
• It produced superior MRD clearance (76.9% vs 45.8%, p<0.0001).
• Treatment-related toxicity was substantially lower, with fewer infections, mucositis, and life-threatening events, though mild neurologic events were higher.
• Non-relapse mortality after transplant was reduced (16% in CA vs. 2.5% in EA).
• Blinatumomab demonstrated superior efficacy and safety, supporting immunotherapy over intensive chemotherapy.
• For the first time, in newly diagnosed ALL, highly toxic chemotherapy elements have successfully been replaced by blinatumomab demonstrating a safer but also superior anti-leukemia efficacy of immunotherapy in prognostically unfavorable pediatric B-ALL.

Ziftomenib Combined With Intensive Induction (7+3) for Newly Diagnosed NPM1‑M OR KMT2A-R Acute Myeloid Leukemia (AML): Long-Term Results from the KOMET-007 Trial

Presenter: Amer M. Zeidan

• Ziftomenib (600 mg daily) combined with standard induction showed promising long-term outcomes in 99 ND AML patients with NPM1 mutations or KMT2A-r in the KOMET-007 trial.
• Regimen was generally well tolerated, with expected hematologic toxicities and low rates of differentiation syndrome and QT prolongation, all manageable.
• High response rates were observed, with composite complete remission of 96% in NPM1-m and 90% in KMT2A-r, and MRD negativity exceeding 80% in both.
• Responses were durable, with encouraging survival outcomes (94% for NPM1-m & 70% for KMT2A-r at 1y). Median CRc duration was not reached for NPM1-m.
• Low rates of additive myelosuppression were observed with this combination.
• Ziftomenib, combined with standard doses of cytarabine/daunorubicin (7+3), was well tolerated with durable responses in ND NPM1-m and KMT2A-r AML.
• This data further supports the ongoing Ph3 registrational trial of ziftomenib in combination with intensive chemotherapy (KOMET-017).

31^st European Hematology Association Congress (EHA 2026),11^th –14^th, 2026, Stockholm, Sweden.