The Association between Patient Characteristics and the Efficacy and Safety of Selinexor in Diffuse Large B-Cell Lymphoma in the SADAL Study



Zijlstra, Josee M, Follows, George, Casasnovas, Rene-Olivier, Vermaat, Joost SP, Kalakonda, Nagesh ORCID: 0000-0002-5300-1360, Choquet, Sylvain, Hill, Brian, Thieblemont, Catherine, Cavallo, Federica, Cruz, Fatima De la
et al (show 20 more authors) (2022) The Association between Patient Characteristics and the Efficacy and Safety of Selinexor in Diffuse Large B-Cell Lymphoma in the SADAL Study. CANCERS, 14 (3). 791-.

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Abstract

Selinexor, an oral selective inhibitor of nuclear export, was evaluated in the Phase 2b SADAL study in patients with diffuse large B-cell lymphoma (DLBCL) who previously received two to five prior systemic regimens. In post hoc analyses, we analyzed several categories of patient characteristics (age, renal function, DLBCL subtype, absolute lymphocyte count, transplant status, number of prior lines of therapy, refractory status, Ann Arbor disease stage, and lactate dehydrogenase) at baseline, i.e., during screening procedures, to determine their potential contributions to the efficacy (overall response rate [ORR], duration of response [DOR], overall survival [OS]) and tolerability of selinexor. Across most categories of characteristics, no significant difference was observed in ORR or DOR. OS was significantly longer for patients < 65 vs. ≥ 65 years, and for those with lymphocyte counts ≥ 1000/µL vs. < 1000/µL or lactate dehydrogenase ≤ ULN vs. > ULN. The most common adverse events (AEs) across the characteristics were thrombocytopenia and nausea, and similar rates of grade 3 AEs and serious AEs were observed. With its oral administration, novel mechanism of action, and consistency in responses in heavily pretreated patients, selinexor may help to address an important unmet clinical need in the treatment of DLBCL.

Item Type: Article
Uncontrolled Keywords: diffuse large B-cell lymphoma, exportin 1, SADAL study, selinexor
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 25 May 2022 09:09
Last Modified: 18 Jan 2023 21:01
DOI: 10.3390/cancers14030791
Open Access URL: https://doi.org/10.3390/cancers14030791
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3155454