Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial
Open accessAbstract
Background Bruton tyrosine kinase is a clinically validated target in mantle cell lymphoma. Acalabrutinib (ACP-196) is a highly selective, potent Bruton tyrosine kinase inhibitor developed to minimise off-target activity.Methods In this open-label, phase 2 study, oral acalabrutinib (100 mg twice per day) was given to patients with relapsed or refractory mantle cell lymphoma, until disease progression or unacceptable toxicity. The primary endpoint was overall response assessed according to the Lugano classification, and safety analyses were done in all participants. This trial is registered with ClinicalTrials.gov, number NCT02213926.Findings From March 12, 2015, to Jan 5, 2016, 124 patients with relapsed or refractory mantle cell lymphoma were enrolled and all patients received treatment; median age 68 years. Patients received a median of two (IQR 1-2) previous therapies. At a median follow-up of 15·2 months, 100 (81%) patients achieved an overall response and 49 (40%) patients achieved a complete response. The Kaplan-Meier estimated medians for duration of response, progression-free survival, and overall survival were not reached; the 12-month rates were 72% (95% CI 62-80), 67% (58-75), and 87% (79-92%), respectively. The most common adverse events were primarily grade 1 or 2 and were headache (47 [38%]), diarrhoea (38 [31%]), fatigue (34 [27%]), and myalgia (26 [21%]). The most common grade 3 or worse adverse events were neutropenia (13 [10%]), anaemia (11 [9%]), and pneumonia (six [5%]). There were no cases of atrial fibrillation and one case of grade 3 or worse haemorrhage. The median duration of treatment was 13·8 months. Treatment was discontinued in 54 (44%) patients, primarily due to progressive disease (39 [31%]) and adverse events (seven [6%]).Interpretation Acalabrutinib treatment provided a high rate of durable responses and a favourable safety profile in patients with relapsed or refractory mantle cell lymphoma. These findings suggest an important role for acalabrutinib in the treatment of this disease population.Funding Acerta Pharma, a member of the AstraZeneca Group.
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Ibrutinib and acalabrutinib have shown beneficial effects in patients with MCL and have received FDA approval for this indication.
“As such, ibrutinib and the more selective BTK inhibitor acalabrutinib 39 have shown beneficial effects in patients with MCL and have received US Food and Drug Administration approval for this indication.”
From Bruton tyrosine kinase degradation as a therapeutic strategy for cancer (2019) · cites this paper as [39]
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- Authors
- Wang, M., Rule, S., Zinzani, P. L., Goy, A., Casasnovas, O., Smith, S. D., Damaj, G., Doorduijn, J., Lamy, T., Morschhauser, F., Panizo, C., Shah, B., Davies, A., Eek, R., Dupuis, J., Jacobsen, E., Kater, A. P., Le Gouill, S., Oberic, L., Robak, T., Covey, T., Dua, R., Hamdy, A., Huang, X., Izumi, R., Patel, P., Rothbaum, W., Slatter, J. G., & Jurczak, W.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- University of Plymouth (GB)
- University of Bologna (IT)
- Hackensack University Medical Center (US)
- Inserm (FR)
- University of Washington (US)
- Centre Hospitalier Universitaire de Caen Normandie (FR)
- Erasmus MC (NL)
- Centre Hospitalier Universitaire de Rennes (FR)
- Centre Hospitalier Universitaire de Lille (FR)
- Clinica Universidad de Navarra (ES)
- Moffitt Cancer Center (US)
- Cancer Research UK (GB)
- Centre Hospitalier Universitaire Henri-Mondor (FR)
- Harvard University (US)
- Amsterdam UMC Location University of Amsterdam (NL)
- Jagiellonian University (PL)
- Corresponding author
- Wang, Michael
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2018-02
- Volume
- 391
- Issue
- 10121
- Pages
- 659-667
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC7864374
- OpenAlex
- W2774522106
- Cited by
- 453
- References
- 23
- Citations by year
- 2026: 39 · 2025: 31 · 2024: 51 · 2023: 49 · 2022: 59 · 2021: 60 · 2020: 63 · 2019: 64 · 2018: 34 · 2017: 1
- FWCI
- 34.80
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- PEARL (University of Plymouth) (submittedVersion, other-oa)
- Homo Politicus (Academy of Humanities and Economics in Lodz) (submittedVersion, cc-by-nc-nd)
- Jagiellonian University Repository (Jagiellonian University) (submittedVersion, cc-by-nc-nd)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- HAL (submittedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, cc-by-nc-nd)
- ePrints Soton (University of Southampton) (submittedVersion)
- PEARL (University of Plymouth) (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Funders
- AstraZeneca
- University of Texas MD Anderson Cancer Center
- National Cancer Institute (P30CA076292)
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Neurology › CNS Lymphoma Diagnosis and Treatment
- Keywords
- acalabrutinib, mantle cell lymphoma, relapsed/refractory lymphoma, BTK inhibitors, overall response rate, complete response, progression-free survival, overall survival, adverse events, neutropenia, drug safety, oral targeted therapy, treatment durability, hemorrhage
- MeSH terms
- Aged, Benzamides, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Pyrazines, Recurrence, Survival Analysis, Treatment Outcome, Lymphoma, Mantle-Cell, Protein Kinase Inhibitors
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