A multicenter, open-label, phase II study of tirabrutinib (ONO/GS-4059) in patients with Waldenström's macroglobulinemia.
Aged
Aged, 80 and over
Biomarkers
Female
Genotype
Humans
Imidazoles
/ administration & dosage
Male
Middle Aged
Mutation
Myeloid Differentiation Factor 88
/ genetics
Neoplasm Grading
Protein Kinase Inhibitors
/ administration & dosage
Pyrimidines
/ administration & dosage
Receptors, CXCR4
/ genetics
Treatment Outcome
Waldenstrom Macroglobulinemia
/ diagnosis
B-cell malignancy
BTK inhibitor
Japanese
Waldenström’s macroglobulinemia
tirabrutinib
Journal
Cancer science
ISSN: 1349-7006
Titre abrégé: Cancer Sci
Pays: England
ID NLM: 101168776
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
04
05
2020
revised:
23
06
2020
accepted:
30
06
2020
pubmed:
9
7
2020
medline:
15
9
2020
entrez:
9
7
2020
Statut:
ppublish
Résumé
Tirabrutinib is a second-generation Bruton's tyrosine kinase inhibitor with greater selectivity than ibrutinib. Here, we conducted a multicenter, phase II study of tirabrutinib in patients with treatment-naïve (Cohort A) or with relapsed/refractory (Cohort B) Waldenström's macroglobulinemia (WM). Patients were treated with tirabrutinib 480 mg once daily. The primary endpoint was major response rate (MRR; ≥ partial response). Secondary endpoints included overall response rate (ORR; ≥ minor response), time to major response (TTMR), progression-free survival (PFS), overall survival (OS), and safety. In total, 27 patients (18 in Cohort A; 9 in Cohort B) were enrolled. The median age was 71 y, and the median serum immunoglobulin M level was 3600 mg/dL. Among the patients, 96.2% had the MYD88
Identifiants
pubmed: 32639651
doi: 10.1111/cas.14561
pmc: PMC7469793
doi:
Substances chimiques
Biomarkers
0
CXCR4 protein, human
0
Imidazoles
0
MYD88 protein, human
0
Myeloid Differentiation Factor 88
0
Protein Kinase Inhibitors
0
Pyrimidines
0
Receptors, CXCR4
0
tirabrutinib
LXG44NDL2T
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
3327-3337Subventions
Organisme : Ono Pharmaceutical
Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2020 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.
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