The ASCEND trial was a global, multicentre, open-label, phase 3 study that randomised 310 patients to receive either acalabrutinib monotherapy or the physician’s choice of either idelalisib plus rituximab or bendamustine. Acalabrutinib is a highly selective, potent inhibitor of BTK that has previously demonstrated substantial activity and improved tolerability in patients with CLL, similar to ibrutinib. In this study, acalabrutinib monotherapy significantly improved progression-free survival, with a more tolerable safety profile, compared with idelalisib plus rituximab or bendamustine in patients with relapsed or refractory CLL, reducing the risk of disease progression or death by 69% at a median follow-up of 16.1 months (HR 0.31; 95% CI 0.20-0.49, P<0.0001). At 12 months, 88% of patients on acalabrutinib showed no disease progression compared with 68% for the control arm, with tolerability consistent with the known profile.
These results are significant because there is a need for an effective but also well-tolerated BTKi for patients with CLL. In addition, no new safety signals were identified for acalabrutinib. The ASCEND study results indicate that acalabrutinib has the potential to change current practice by providing a well-tolerated, highly effective BTKi treatment option.
Dr Ghia concluded: “This is the first randomised study to directly compare a BTK inhibitor as monotherapy with standard chemoimmunotherapy or idelalisib and rituximab combinations. With a significant improvement in progression-free survival and a favourable safety profile, acalabrutinib may become an important choice for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia.”
- Ghia P, et al. LB2601, 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 “don’t eat me” 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-naïve, 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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