Please use this identifier to cite or link to this item: http://hdl.handle.net/11054/1615
Title: Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma.
Author: Lenz, Georg
Hawkes, Eliza
Verhoef, Gregor
Haioun, Corinne
Lim, Soon T.
Heo, Dae S.
Ardeshna, Kirit
Chong, Geoffrey
Haaber, Jacob
Shi, Wei
Gorbatchevsky, Igor
Lippert, Susanne
Hiemeyer, Florian
Piraino, Paolo
Beckmann, Georg
Pena, Carol
Buvaylo, Viktoriya
Childs, Barrett
Salles, Gilles
Issue Date: 2020
Publication Title: Leukemia
Volume: 34
Start Page: 2184
End Page: 2197
Abstract: Patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) have adverse outcomes. We evaluated the efficacy and safety of the phosphatidylinositol 3-kinase inhibitor copanlisib in patients with relapsed/refractory DLBCL and assessed the relationship between efficacy and DLBCL cell of origin (COO; activated B-cell like [ABC] and germinal center B-cell like [GCB]) and other biomarkers. The primary endpoint was objective response rate (ORR) in DLBCL COO subgroups (ABC, GCB, and unclassifiable) and by CD79B mutational status (NCT02391116). Sixty-seven patients received copanlisib (ABC DLBCL, n = 19; GCB DLBCL, n = 30; unclassifiable, n = 3; missing, n = 15). The ORR was 19.4%; 31.6% and 13.3% in ABC and GCB DLBCL patients, respectively. ORR was 22.2%/20.0% for patients with/without CD79B mutations (wild type, n = 45; mutant, n = 9; missing, n = 13). Overall median progression-free survival and duration of response were 1.8 and 4.3 months, respectively. Adverse events included hypertension (40.3%), diarrhea (37.3%), and hyperglycemia (32.8%). Aberrations were detected in 338 genes, including BCL2 (53.7%) and MLL2 (53.7%). A 16-gene signature separating responders from nonresponders was identified. Copanlisib treatment demonstrated a manageable safety profile in patients with relapsed/refractory DLBCL and a numerically higher response rate in ABC vs. GCB DLBCL patients.
URI: http://hdl.handle.net/11054/1615
DOI: https://doi.org/10.1038/s41375-020-0743-y
Internal ID Number: 01563
Health Subject: REFRACTORY
RELAPSED
DIFFUSE LARGE B-CELL LYMPHOMA
DLBCL
PHOSPHATIDYLINOSITOL
Type: Journal Article
Article
Appears in Collections:Research Output

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