https://doi.org/10.55788/85a7cc93
Azacitidine plus venetoclax is the standard-of-care for older or unfit patients with FLT3-mutated AML. However, the 1-year overall survival (OS) rate is low, at 40–60% [1]. Therefore, researchers tested a regimen of azacitidine, venetoclax, and gilteritinib, an FLT3 inhibitor that improves OS in patients with relapsed/refractory FLT3-mutated AML [2].
Patients with relapsed/refractory FLT3-mutated AML (n=20) or newly diagnosed FLT3-mutated AML, unfit for intensive chemotherapy (n=27), received a regimen of azacitidine, venetoclax, and gilteritinib (80 or 120 mg, once daily) in a phase 1/2 study. After the phase 1 part of the study, 80 mg was selected as the phase 2 expansion dose. The primary endpoint of the phase 2 part of the trial was complete remission (CR)/ complete remission with incomplete count recovery (CRi). Prof. Nicholas Short (University of Texas, TX, USA) presented the results [3].
CR was achieved in 92% of the participants who were treated with the triplet regimen in the frontline. The 2 remaining participants in this cohort achieved CRi and a morphologic leukaemia-free state (MLFS) response, respectively. Correspondingly, 20% of the participants in the relapsed/refractory cohort reached CR, 15% achieved CRi, and 35% had an MLFS response. In addition, 93% of the participants in the frontline cohort were on marrow remission after 14 days or had an aplastic marrow. In the relapsed/refractory cohort, the corresponding rate was 63%. Furthermore, MRD-negativity, assessed through flow cytometry, was achieved in 82% and 43% of the participants in the frontline cohort and relapsed/refractory cohort, respectively. The 1-year OS rate was 85% in the frontline cohort and 30% in the relapsed/refractory cohort.
“In the frontline cohort, the regimen was generally well tolerated, with minimal non-haematological toxicity,” said Prof. Short. Myelosuppression was common but manageable with dose adaptations. One patient died due to an infection in this cohort. “In the relapsed/refractory cohort, most adverse events were related to myelosuppression but mostly manageable with mitigation strategies.” In this cohort, there were 4 unsteady deaths, 2 due to an infection, 1 because of an intracranial haemorrhage, and 1 due to disseminated intravascular coagulation.
- Konopleva M, et al. Clin Cancer Research. 2022;28(13):2744–2752.
- Perl AE, et al. N Engl J Med. 2019;381(18):728–740.
- Short NJ, et al. Updated Results from a Phase I/II Study of the Triplet Combination of Azacitidine, Venetoclax and Gilteritinib for Patients with FLT3-Mutated Acute Myeloid Leukemia. Abstract 831, ASH 64th Annual Meeting, 10–13 December 2022, New Orleans, LA, USA.
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Table of Contents: ASH 2022
Featured articles
Acute Lymphoblastic Leukaemia
Blinatumomab candidate for standard-of-care in newly diagnosed B-ALL
High-dose methotrexate or standard interim maintenance in young patients with ALL?
Acute Myeloid Leukaemia
Excellent results for triplet regimen in FLT3-mutated AML
MRD by qPCR prognostic of outcomes in venetoclax-treated NPM1-mutated AML
Promising results for triplet therapy with magrolimab in AML
Should we use intensive chemotherapy prior to allo-HCT in relapsed/refractory AML?
Chronic Leukaemia
Zanubrutinib wins battle of BTK inhibitors in relapsed or refractory CLL/SLL
Ibrutinib plus venetoclax displays long-term benefits in CLL
Multiple Myeloma
Talquetamab further investigated in heavily pre-treated MM after promising phase 2 data
Promising results of elranatamab for MM in phase 2 MagnetisMM-3 trial
Deep and durable responses for quadruple therapy in smouldering MM
Ultra-sensitive MRD assessment in MM with BloodFlow
CAR-Hematotox score proves useful in relapsed/refractory MM
Head-to-head: VMP versus Rd in transplant-ineligible MM
Lymphoma
Ibrutinib added to ASCT improves clinical outcomes in mantle cell lymphoma
High-dose chemotherapy plus ASCT superior to standard immuno-chemotherapy in primary CNS lymphoma
Odronextamab has considerable anti-tumour effects in relapsed/refractory diffuse large B-cell lymphoma and follicular lymphoma
Excellent results for AFM13-complexed NK cells in CD30-positive lymphoma
CAR-Hematotox score predicts toxicity, infections, and clinical outcomes in MCL
Myeloproliferative Neoplasms
Efgartigimod successful in immune thrombocytopenia
INCA033989: novel investigational agent for CALR-mutated MPN
Ruxolitinib mediates clonal evolution of RAS pathway mutations in MPN
Immune Thrombocytopenia
Long-term risk for haematologic disease in persistent, isolated mild thrombocytopenia
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C1 inhibitor deficiency linked to thrombosis
Durable responses to gene therapy in haemophilia A
Long-term benefits from beti-cel in transfusion-dependent β-thalassaemia
Neutrodiet: non-restricted diet is the preferred option after SCT
Iptacopan offers solution for patients with PNH and residual anaemia after standard-of-care
Novel therapy may replace standard-of-care prophylaxis for GVHD
LMWH does not result in higher live birth rates in women with inherited thrombophilia
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