Startseite Kongressberichte 2021 63rd ASH Annual Meeting and Exposition In-Person/Virtual AML Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies Targeted Therapies and Novel Therapies

616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Targeted Therapies and Novel Therapies

697
AGILE: A Global, Randomized, Double-Blind, Phase 3 Study of Ivosidenib + Azacitidine Versus Placebo + Azacitidine in Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation

Pau Montesinos, Christian Recher, Susana Vives, et al.

The results of this study significantly demonstrate the clinical benefit of ivosidenib (IVO) + azacitidine (AZA) compared to placebo + AZA in a difficult-to-treat AML population: the combination improved event-free survival, overall survival, and clinical response (CR, CR + CRh, ORR) in these patients with IC-ineligible, newly diagnosed mIDH1-AML. The favorable safety profile of IVO + AZA was consistent with previous studies.

 

698
Olutasidenib (FT-2102) in Combination with Azacitidine Induces Durable Complete Remissions in Patients with mIDH1 Acute Myeloid Leukemia

Jorge E. Cortes, Jordi Esteve, Ashish Bajel, et al.

Olutasidenib plus azacitidine induced durable CR/CRh in a subgroup of high-risk patients with mIDH1-AML. The combination was well tolerated. In all cohorts, some of those treated achieved transfusion independence. Further analyzes on safety and efficacy will be presented at the oral session.

 

699
Safety and Efficacy of Menin Inhibition in Patients (Pts) with MLL-Rearranged and NPM1 Mutant Acute Leukemia: A Phase (Ph) 1, First-in-Human Study of SNDX-5613 (AUGMENT 101)

Eytan M. Stein, Ibrahim Aldoss, John F. DiPersio, et al.

SNDX-5613 demonstrated an acceptable safety profile. Promising antileukemic activity has been observed in patients with heavily pretreated R / R MLLr and mNPM1 acute leukemia. The pre-established criteria for RP2D were met with two dose levels in each arm.

 

700
Phase 3, Open-Label, Randomized Study of Gilteritinib and Azacitidine Vs Azacitidine for Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia in Patients Ineligible for Intensive Induction Chemotherapy

Eunice S. Wang, Pau Montesinos, Mark D. Minden, et al.

The combination of gilteritinib (GIL) + azacitidine (AZA) achieved significantly higher CRc rates in the absence of new safety signals, but similar OS compared to AZA alone. Patients with ECOG PS 0-1 and high FLT3-ITD allele ratio appeared to have greater benefit with the combination. Strange: the Ctrough values in patients with ND FLT3mut + AML who were not suitable for IIC were 2 times higher than in patients with R/R FLT3mut + AML. The study results confirm the safety, tolerability and activity of the combination compared to AZA.

 

701 ASH denotes this abstract as clinically relevant 
Venetoclax Combined with FLAG-IDA Induction and Consolidation in Newly Diagnosed Acute Myeloid Leukemia

Curtis Lachowiez, Courtney D. DiNardo, Koichi Takahashi, et al.

Induction and consolidation with fludarabine, high-dose cytarabine (Ara-C0), idarubicin and granulocyte colony-stimulating factor (G-CSF) plus venetoclax (FLAG-IDA + VEN) leads to high MRD-negative CRc rates in ND-AML with an expected safety profile. After one year there was a sustained response with favorable results compared to historical cohorts of intensive therapy. With TP53 mutations there were inferior outcomes in comparison to wild-type TP53.

 

702
First in Human (FIH) FLT3 and SYK Inhibitor HM43239 Shows Single-Agent Activity in Patients (pts) with Relapsed or Refractory (R/R) FLT3 Mutated and Wild-Type Acute Myeloid Leukemia (AML)

Naval Daver,  Kyoo Hyung Lee, Chul Won Jung, et al.

HM43239 is a preclinically effective FLT3 and SYK inhibitor. In the present study, the substance showed a favorable safety profile with only slight undesirable side effects and no redefining dose-limiting toxicity (DLT). At 80 mg, HM43239 shows clinical activity in both FLT3m and FLT3wt-AML. Updated data on response, safety and PK / PD will be presented in the oral session.