Long-Term Follow-Up of Acalabrutinib Monotherapy in Patients with Relapsed/Refractory Mantle Cell Lymphoma

Wang, Michael; Rule, Simon; Zinzani, Pier Luigi; Goy, André; Casasnovas, Oliver; Smith, Stephen C.; Damaj, Gandhi; Doorduijn, Jeanette K.; Lamy, Thierry; Morschhauser, Franck; Panizo, Carlos; Shah, Bijal; Davies, Andrew; Eek, Richard; Dupuis, Jehan; Jacobsen, E.; Kater, Arnon P.; Gouill, Steven Le; Obéric, Lucie; Robak, T; Dua, Richa; Frigault, Melanie M.; Izumi, Raquel; Nguyen, Dorothy D.; Patel, Priti R.; Yin, Min; Jurczak, Wojciech

doi:10.1016/j.clml.2019.07.291

Cited by 7 publications

(19 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The most frequent AE is headache, which typically occurs within the first month of acalabrutinib treatment, for a median duration of 11 days; many patients (77%) experience only one event. 45,65 In our experience, headaches can be managed by increasing caffeine intake or by administration of acetaminophen.…”

Section: Ae Managementmentioning

confidence: 99%

“…65 Treatment resulted in high rates of durable response, with a median duration of response (DOR) of 26 months and a median PFS of 20 months. 65 A total of 28% (8/29) of patients that were analysed for minimal residual disease (MRD) demonstrated MRD negativity with acalabrutinib treatment. 66 Acalabrutinib showed a favourable safety profile, with most AEs observed being grade 1/2.…”

Section: Clinical Studies Of Acalabrutinib In Patients With MCLmentioning

confidence: 99%

“…65 Common AEs of grade ≥3 included anaemia (10%), neutropenia (10%), diarrhoea (3%) and dyspnoea (2%). 65 At 15.2 months of follow-up, treatment-related serious AEs (SAEs) occurred in 10% of patients, none of which were reported in more than one patient. 45 At 26 months of follow-up, bleeding events occurred in 33% of patients and were mainly grade 1/2 events; importantly, AF was not observed during the reported follow-up period.…”

Section: Clinical Studies Of Acalabrutinib In Patients With MCLmentioning

confidence: 99%

“…45 At 26 months of follow-up, bleeding events occurred in 33% of patients and were mainly grade 1/2 events; importantly, AF was not observed during the reported follow-up period. 45,65 Clinical studies of acalabrutinib in patients with CLL…”

Section: Clinical Studies Of Acalabrutinib In Patients With MCLmentioning

confidence: 99%

“…Diarrhoea is common during the first 6 months of treatment, with a median time of onset and resolution of 50 and 7 days, respectively. 45,65 In clinical practice, we rarely observe diarrhoea interfering with daily activities, but loperamide can be prescribed when quality of life is affected.…”

Section: Ae Managementmentioning

confidence: 99%

See 4 more Smart Citations

Incorporating acalabrutinib, a selective next‐generation Bruton tyrosine kinase inhibitor, into clinical practice for the treatment of haematological malignancies

Danilov

Persky

2020

Br J Haematol

View full text Add to dashboard Cite

Greater understanding of the mechanisms involved in the disease progression of haematological malignancies has led to the introduction of novel targeted therapies with reduced toxicity compared with chemotherapy-based regimens, which has expanded the treatment options for patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukaemia/ small lymphocytic lymphoma (CLL/SLL). Ibrutinib is a firstin-class Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of patients with CLL/SLL or relapsed/refractory MCL. However, next-generation BTK inhibitors have been developed with improved specificity and the potential to reduce the off-target toxicity observed with ibrutinib. Acalabrutinib is a highly selective, next-generation BTK inhibitor, which was granted accelerated approval by the US Food and Drug Administration in 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. In November 2019, it was also granted approval for the treatment of adult patients with CLL/SLL on the basis of two phase 3 clinical trials. This review describes the current understanding of acalabrutinib according to clinical study data for the treatment of MCL and CLL/SLL and shares recommendations from our practice on how it should be used when treating patients in the clinic, including dosing, administration and management of adverse events.

show abstract

Section: Ae Managementmentioning

confidence: 99%