Prof. Patrick A. Brown (Johns Hopkins Kimmel Cancer Center, Baltimore, USA) presented the results of the randomised, phase 3 AALL1331 trial, which aimed to specifically test the benefits of the bispecific antibody blinatumomab (binding both CD19 expressed on B cells and CD3 expressed on T cells) in children and young adults with minimal residual disease (MRD) after chemotherapy [1]. The unmet need this trial attempted to address was that young patients with MRD are frequently unable to proceed to bone marrow transplant and are consequently prone to relapse and death.
All patients enrolled (n=208; aged 1-30 years) had high- or intermediate-risk B-ALL at first relapse after 1 month of standard chemotherapy. Patients were randomised to either a control arm, which received 2 blocks of intensive chemotherapy (n=103) or 2 cycles of blinatumomab (n=105). Patients were then worked up for HSCT. The primary endpoint of this study was disease-free survival Secondary endpoints were MRD clearance, safety, and bridge to a successful HSCT.
The primary endpoint was met. With a median follow-up of 1.4 years, the disease-free survival of the blinatumomab arm was 59.3% compared with 41.0% with those who received intensive chemotherapy (P=0.050). Overall survival at 2 years was 79.4% and 59.2% with blinatumomab and chemotherapy, respectively (P=0.005).
The secondary endpoints were also met. Blinatumomab significantly improved MRD clearance at both treatment points tested (P<0.0001). No new safety signals were observed for either treatment, although the incidence of serious treatment-related adverse events ≥ grade 3, such as febrile neutropenia, infection, sepsis, or mucositis, was significantly higher in the chemotherapy arm than the blinatumomab arm (P<0.001).
Importantly, given that the best opportunity for a curative treatment is HSCT, the patients in the blinatumomab arm (73%) were more likely to successfully bridge to transplant than those patients in the intensive chemotherapy arm. At the end of the chemotherapy treatment, 45% of participants went on to transplant (P<0.0001).
Prof. Brown: “Based on our study, it appears that blinatumomab is a much more effective bridge to transplant for this patient population, leading to a much larger portion of patients who are actually able to receive a bone marrow transplant. We believe that is the reason for the striking improvement in survival among patients who received blinatumomab.”
- Brown P, et al. A Randomized Phase 3 Trial of Blinatumomab Vs. Chemotherapy As Post-Reinduction Therapy in High and Intermediate Risk (HR/IR) First Relapse of B-Acute Lymphoblastic Leukemia (B-ALL) in Children and Adolescents/Young Adults (AYAs) Demonstrates Superior Efficacy and Tolerability of Blinatumomab: A Report from Children’s Oncology Group Study AALL1331. Abstract LBA-1, 61st ASH Annual Meeting, Orlando, FL, USA, 7-10 December 2019.
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Table of Contents: ASH 2019
Featured articles
Late-Breaking Abstracts
Likely new standard of care: Blinatumomab for children with relapsed B-ALL
Pivotal phase 3 trial in cold agglutinin disease: sutimlimab can stop haemolysis
Oral azacitidine improves overall survival in patients with AML in remission
BCL11A as a novel target in gene therapy for sickle cell disease
Adding daratumumab to carfilzomib/dexamethasone prolongs PFS and OS in R/R MM
Long-term data of ropeginterferon alpha-2b in polycythaemia vera
Anti-CD70 is safe with hypomethylating agents in AML
MRD assessment to guide pre-emptive treatment decisions
Luspatercept effective for myelofibrosis-associated anaemia
Arsenic, ATRA, and ascorbic acid in acute promyelocytic leukaemia maintenance
Updated results ECOG-ACRIN E2906: decitabine maintenance after alloSCT
Sickle Cell Disease
Arginine supplements help against sickle cell disease pain
Abatacept prevents graft-versus-host disease in sickle cell patients after alloSCT
Plenary Scientific Session
HOVON-96: Better outcomes with cyclophosphamide after transplantation
Erythroferrone and skeletal changes associated with thalassaemia
Experimental model for limitations of haematopoietic stem cells propagation
Mosunetuzumab: complete remissions in non-Hodgkin lymphoma
Inclusive Medicine
Socioeconomic disparities and survival in paediatric AML
Oral selinexor/pomalidomide/dexamethasone shows activity in heavily pre-treated multiple myeloma
CAR T-cell therapy successful in older non-Hodgkin’s lymphoma patients
Mild renal impairment in African Americans does not affect OS in AML
ALCYONE: New overall survival results for myeloma
Venous Thromboembolism
Rivaroxaban is safe and effective for paediatric venous thromboembolism
Aspirin plus DOAC is not better than a DOAC alone
20-Year follow-up of imatinib in chronic myeloid leukaemia after failure with interferon
CAR T and Beyond
BCMA-targeted CAR T therapy yields 100% response in relapsed/refractory MM
Anti-BCMA/anti-CD38 in refractory multiple myeloma
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