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

Josée M. Zijlstra, George Follows, Rene Olivier Casasnovas, Joost S.P. Vermaat, Nagesh Kalakonda, Sylvain Choquet, Brian Hill, Catherine Thieblemont, Federica Cavallo, Fatima De la Cruz, John Kuruvilla, Nada Hamad, Ulrich Jaeger, Paolo Caimi, Ronit Gurion, Krzysztof Warzocha, Sameer Bakhshi, Juan Manuel Sancho, Michael Schuster, Miklos EgyedFritz Offner, Theodoros P. Vassilakopoulos, Priyanka Samal, Matthew Ku, Jenny Xu, Kelly Corona, Kamal Chamoun, Jatin Shah, Miguel Canales, Marie Maerevoet

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Article number791
JournalCancers
Volume14
Issue number3
DOIs
StatePublished - 1 Feb 2022

Keywords

  • Diffuse large B-cell lymphoma
  • Exportin 1
  • SADAL study
  • Selinexor

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