PMID- 35861370
OWN - NLM
STAT- MEDLINE
DCOM- 20220928
LR  - 20221231
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Print)
IS  - 0007-1048 (Linking)
VI  - 199
IP  - 1
DP  - 2022 Oct
TI  - A phase 2, multicentre, open-label trial (ACE-LY-003) of acalabrutinib in 
      patients with relapsed or refractory marginal zone lymphoma.
PG  - 76-85
LID - 10.1111/bjh.18368 [doi]
AB  - Acalabrutinib, a Bruton tyrosine kinase inhibitor, demonstrated greater 
      selectivity and improved safety versus ibrutinib in a head-to-head trial in 
      relapsed/refractory (R/R) chronic lymphocytic leukaemia. In the R/R marginal zone 
      lymphoma (MZL) cohort (phase 2) of a phase 1b/2 trial (NCT02180711), 43 patients 
      with MZL and at least one prior therapy received acalabrutinib 100 mg twice daily 
      until disease progression or unacceptable toxicity [median age 69 years (range 
      42-84); median one (1-4) prior systemic regimens]. Median follow-up was 
      13.3 months (range 0.5-45.5). Among 40 patients evaluable for response, 
      investigator-assessed overall response rate was 53% [95% confidence interval (CI) 
      36%-69%] with five (13%) complete responses. Tumour reduction occurred in 40 
      (93%) of the treated patients. Median time to response was 2.9 months (median 
      duration of response not estimable). Estimated median progression-free survival 
      (PFS) was 27.4 months (12-month PFS rate, 67%). Five patients died (disease 
      progression, n = 4; septic shock, n = 1). Seventeen patients (40%) had grade 3 or 
      higher adverse events (AEs), most commonly neutropenia (14%), anaemia, dyspnoea 
      (7% each), fatigue and thrombocytopenia (5% each). Hypertension occurred in 5%; 
      atrial fibrillation/flutter and major haemorrhage were not reported. AEs led to 
      treatment discontinuation in three (7%) patients. Acalabrutinib was active and 
      well tolerated in patients with R/R MZL.
CI  - (c) 2022 The Authors. British Journal of Haematology published by British Society 
      for Haematology and John Wiley & Sons Ltd.
FAU - Strati, Paolo
AU  - Strati P
AUID- ORCID: 0000-0002-7445-1459
AD  - The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
FAU - Coleman, Morton
AU  - Coleman M
AD  - Clinical Research Alliance/Weill Cornell Medicine, New York, New York, USA.
FAU - Champion, Rebecca
AU  - Champion R
AD  - Norton Cancer Institute, Louisville, Kentucky, USA.
FAU - Ma, Shuo
AU  - Ma S
AD  - Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, 
      Illinois, USA.
FAU - Patti, Caterina
AU  - Patti C
AD  - A.O.O.R. Villa Sofia-Cervello, U. O. C. Oncoematologia, Palermo, Italy.
FAU - Levy, Moshe Y
AU  - Levy MY
AD  - Baylor University Medical Center, Dallas, Texas, USA.
FAU - Lossos, Izidore S
AU  - Lossos IS
AUID- ORCID: 0000-0002-9346-9013
AD  - University of Miami-Miller School of Medicine, Miami, Florida, USA.
FAU - Geethakumari, Praveen Ramakrishnan
AU  - Geethakumari PR
AD  - Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern 
      Medical Center, Dallas, Texas, USA.
FAU - Lam, Selay
AU  - Lam S
AD  - London Health Sciences Centre, London, Ontario, Canada.
FAU - Calvo, Roser
AU  - Calvo R
AD  - AstraZeneca, Gaithersburg, Maryland, USA.
FAU - Higgins, Kara
AU  - Higgins K
AD  - AstraZeneca, South San Francisco, California, USA.
FAU - Budde, Lihua E
AU  - Budde LE
AUID- ORCID: 0000-0003-1464-5494
AD  - City Of Hope National Medical Center, Duarte, California, USA.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220721
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 0 (Benzamides)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrazines)
RN  - I42748ELQW (acalabrutinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Benzamides
MH  - Disease Progression
MH  - Humans
MH  - *Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy
MH  - *Lymphoma, B-Cell, Marginal Zone/drug therapy
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/drug therapy
MH  - Protein Kinase Inhibitors/adverse effects
MH  - Pyrazines
MH  - Treatment Outcome
PMC - PMC9796553
OTO - NOTNLM
OT  - B-cell lymphoma
OT  - Bruton tyrosine kinase
OT  - non-Hodgkin lymphoma
COIS- Paolo Strati has consulted and served on an advisory board for Roche-Genentech, 
      ADC Therapeutics, TG Therapeutics and Hutchinson-MediPharma, and has received 
      research support from AstraZeneca, Acerta and ALX Oncology. Morton Coleman has 
      served on advisory boards and received research support from AbbVie, AstraZeneca, 
      BeiGene, Loxo Oncology, Janssen Pharmaceuticals, Pharmacyclics, Bristol Meyers 
      Squibb and Gilead Sciences. Rebecca Champion has served on the speakers' bureau 
      for Bristol Myers Squibb and AbbVie and has received honoraria for advisory 
      boards for BeiGene. Shuo Ma has received research grants from AbbVie, 
      AstraZeneca, BeiGene, Janssen, Juno, Loxo, Pharmacyclics and TG Therapeutics; 
      received honoraria for advisory board or consulting from AbbVie, AstraZeneca, 
      BeiGene, Genentech, Janssen, Pharmacyclics and TG Therapeutics, and served on 
      speakers' bureaus for AstraZeneca, BeiGene, Janssen and Pharmacyclics. Caterina 
      Patti has received honoraria for advisory board or consulting from AbbVie, 
      AstraZeneca, Janssen and Takeda. Moshe Y. Levy has served as a 
      consultant/promotional speaker for AbbVie, Amgen Inc., Bristol Myers Squibb, 
      Janssen Pharmaceuticals, Karyopharm, Morphosys, Seattle Genetics, Takeda, 
      AstraZeneca, BeiGene, Gilead Sciences, Jazz Pharmaceuticals, TG Therapeutics, 
      Epizyme, GSK, Novartis and Dova. Izidore S. Lossos has served on advisory boards 
      for Seattle Genetics, Janssen Scientific, Adaptive Biotechnologies, Verastem and 
      Pharmacyclics. Praveen Ramakrishnan Geethakumari has provided consultancy for 
      Kite Pharma, Pharmacyclics and Rafael Pharmaceuticals. Selay Lam has received 
      honoraria from AbbVie, Amgen, AstraZeneca, BeiGene, BMS, Gilead Sciences, Roche, 
      Janssen, Novartis, Sanofi and Seattle Genetics, and has served in a consulting or 
      advisory role for AbbVie, Amgen, AstraZeneca, BeiGene, BMS, Gilead Sciences, 
      Roche, Janssen, Novartis, Sanofi and Seattle Genetics. Rebecca Champion is a paid 
      employee of AstraZeneca and reports stock ownership in the company. Kara Higgins 
      is a paid employee of AstraZeneca. Lihua E. Budde has served on advisory boards 
      for Genentech/Roche, ADC Therapeutics, BeiGene and Gilead Sciences and has 
      received research grants from Mustang Therapeutics, Merck, Amgen and AstraZeneca.
EDAT- 2022/07/22 06:00
MHDA- 2022/09/28 06:00
PMCR- 2022/12/28
CRDT- 2022/07/21 08:13
PHST- 2022/06/24 00:00 [revised]
PHST- 2022/04/22 00:00 [received]
PHST- 2022/07/07 00:00 [accepted]
PHST- 2022/07/22 06:00 [pubmed]
PHST- 2022/09/28 06:00 [medline]
PHST- 2022/07/21 08:13 [entrez]
PHST- 2022/12/28 00:00 [pmc-release]
AID - BJH18368 [pii]
AID - 10.1111/bjh.18368 [doi]
PST - ppublish
SO  - Br J Haematol. 2022 Oct;199(1):76-85. doi: 10.1111/bjh.18368. Epub 2022 Jul 21.