FLT3 mutations (FLT3MUT+) occur in approximately 30% of patients with AML and are often associated with poor survival. Results from the ADMIRAL trial show the median overall survival for R/R FLT3MUT+ AML patients who received gilteritinib was 9.3 months vs 5.6 months for patients who received salvage chemotherapy (HR 0.637; 95% CI 0.490-0.830; P=0.007); 1-year survival rates were 37% for patients who received gilteritinib vs 17% for patients who received salvage chemotherapy (see Table).
Table: The gilteritinib arm had superior response rates across all 4 major co-mutation cohorts in the ADMIRAL trial
ITT, intention to treat; CR/CRh, complete remission/with partial haematological recovery; SC, salvage chemotherapy; HR, hazard ratio. Permission granted by Dr Perl to use abbreviated Table.
The most common treatment-emergent adverse events of any grade occurring in ā„10% of patients during the first 30 days of treatment with gilteritinib were anaemia (33%), increased transaminases (24%), febrile neutropenia (21%), thrombocytopenia (19%), constipation (17%), pyrexia (15%), fatigue (15%), decreased neutrophil count (14%), increased blood alkaline phosphatase (13%), nausea (13%), hypokalaemia (11%), cough (11%), headache (10%), and diarrhoea (10%).
Dr Perl concluded that the clinical benefit of gilteritinib was maintained regardless of the presence of NPM1, DNMT3A, or WT1 co-mutations (see Table). Relative to the other co-mutated cohorts, patients with both NPM1 and DNMT3A co-mutations had the greatest survival benefit with gilteritinib. āWe are very encouraged by the findings of the ADMIRAL trial,ā said Dr Perl. āPatients with relapsed/refractory FLT3 mutation-positive AML generally have a poor prognosis and short survival. Until just recently, they had few treatment options.ā This experimental therapy is an oral drug that can be given on an outpatient basis, while salvage chemotherapy patients mostly are admitted for a couple of weeks in the hospital. Even if the outcome would have been equal, it offers an enormous advantage for the patient. āThese findings are practice changing for this patient population.ā
- Perl A et al. Abstract S876. 24th Congress of the EHA, 13-16 June 2019, Amsterdam, the Netherlands.
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Table of Contents: EHA 2019
Featured articles
Editor Biography
Interview with EHA President Prof. Pieter Sonneveld
Myeloid Malignancies
Residual disease in AML patients prior to stem cell transplant increases relapse risk
Gilteritinib prolongs overall survival in patients with FLT3-mutated relapsed/refractory AML
Initial data on AMV564 in patients with relapsed/refractory AML
Overcoming the ādonāt eat meā signal in AML and MDS
Asciminib plus imatinib in patients with heavily pre-treated chronic myeloid leukaemia
Guadecitabine vs treatment of choice in AML
Lymphoid Malignancies
Unmutated IGHV as predictive factor for venetoclax/obinutuzumab benefit in frontline CLL
CAR-T cell therapy in ALL as breakthrough advance
Brentuximab vedotin continues to demonstrate superior clinical activity in classical Hodgkin lymphoma
Infectious complications mild and not common in patients receiving CAR-T therapy for diffuse large B cell lymphoma
Obinutuzumab/polatuzumab in follicular lymphoma
Exciting survival data for ibrutinib vs placebo in treatment-naĆÆve, early-stage CLL
ASCEND study: Acalabrutinib improves progression-free survival in relapsed/refractory CLL
Venetoclax-obinutuzumab combination elicits high response rates in CLL
Myeloma
CASSIOPEIA trial: Phase 3 results of daratumumab + bortezomib/thalidomide/dexamethasone in multiple myeloma
Chimeric antigen receptor T cell therapy in multiple myeloma
Higher levels of treatment satisfaction without compromising efficacy: subcutaneous daratumumab in RRMM
Adding isatuximab to pomalidomide and dexamethasone improves PFS and ORR in RRMM
Subcutaneous daratumumab + cyclophosphamide, bortezomib, and dexamethasone in patients with newly diagnosed amyloid light chain amyloidosis
Venetoclax for multiple myeloma: effective but some safety concerns
Benign Haematology
New sickle cell drug voxelotor boosts levels of haemoglobin
Positive initial data evaluating the safety and efficacy of IMR-687 for treatment of sickle cell disease
Haematopoietic stem cell transplantation improves stroke risk in children with sickle cell anaemia
Early trial data shows positive results for treating anaemia in patients with end-stage renal failure
Bench-to-Bedside
Transformation of foetal haematopoietic stem and progenitor cells in the background of trisomy 21
Treating thalassemia twice, in mice
Haematopoietic stem cells can sense tissue damage in the gut
Promising news for gene therapy for sickle cell disease
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