Transcriptomic profiles and 5-year results from the randomized CLL14 study of venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab in chronic lymphocytic leukemia.
Journal
Nature communications
ISSN: 2041-1723
Titre abrégé: Nat Commun
Pays: England
ID NLM: 101528555
Informations de publication
Date de publication:
18 04 2023
18 04 2023
Historique:
received:
24
08
2022
accepted:
24
03
2023
medline:
20
4
2023
pubmed:
19
4
2023
entrez:
18
04
2023
Statut:
epublish
Résumé
Data on long-term outcomes and biological drivers associated with depth of remission after BCL2 inhibition by venetoclax in the treatment of chronic lymphocytic leukemia (CLL) are limited. In this open-label parallel-group phase-3 study, 432 patients with previously untreated CLL were randomized (1:1) to receive either 1-year venetoclax-obinutuzumab (Ven-Obi, 216 patients) or chlorambucil-Obi (Clb-Obi, 216 patients) therapy (NCT02242942). The primary endpoint was investigator-assessed progression-free survival (PFS); secondary endpoints included minimal residual disease (MRD) and overall survival. RNA sequencing of CD19-enriched blood was conducted for exploratory post-hoc analyses. After a median follow-up of 65.4 months, PFS is significantly superior for Ven-Obi compared to Clb-Obi (Hazard ratio [HR] 0.35 [95% CI 0.26-0.46], p < 0.0001). At 5 years after randomization, the estimated PFS rate is 62.6% after Ven-Obi and 27.0% after Clb-Obi. In both arms, MRD status at the end of therapy is associated with longer PFS. MRD + ( ≥ 10
Identifiants
pubmed: 37072421
doi: 10.1038/s41467-023-37648-w
pii: 10.1038/s41467-023-37648-w
pmc: PMC10113251
doi:
Substances chimiques
venetoclax
N54AIC43PW
obinutuzumab
O43472U9X8
Chlorambucil
18D0SL7309
Bridged Bicyclo Compounds, Heterocyclic
0
Banques de données
ClinicalTrials.gov
['NCT02242942']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2147Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2023. The Author(s).
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