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Comparison of the Effectiveness and Safety of the Oral Selective Inhibitor of Nuclear Export, Selinexor, in Diffuse
Rene-Olivier Casasnovas1, George Follows2, Josee M Zijlstra3
1Hématologie Clinique and INSERM 1231, CHU Dijon Bourgogne, Dijon, France.
Background:
The SADAL study evaluated oral selinexor in patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL) after at least 2 prior lines of systemic therapy. In this post-hoc analysis, we analyzed the outcomes of the SADAL study by DLBCL subtype to determine the effects of DLBCL subtypes on efficacy and tolerability of selinexor.
Patients And Methods:
Data from 134 patients in SADAL were analyzed by DLBCL subtypes for overall response rate (ORR), overall survival (OS), duration of treatment response, progression-free survival, and adverse events rate.
Results:
ORR in the entire cohort was 29.1%, and similar in patients with germinal center (GCB) versus non-GCB DLBCL (31.7% vs. 24.2%, P = 0.45); transformed DLBCL showed a trend towards higher ORR than de novo DLBCL: 38.7% vs. 26.2% (P = 0.23). Despite similar prior treatment regimens and baseline characteristics, patients with DLBCL and normal C-MYC/BCL-2 protein expression levels had a significantly higher ORR (46.2% vs.14.8%, P = 0.012) and significantly longer OS (medians 13.7 vs. 5.1 months, hazard ratio 0.43 [95% CI, 0.23-0.77], P = 0.004) as compared with those whose DLBCL had C-MYC and BCL-2 overexpression. Among patients who had normal expression levels of either C-MYC or BCL-2 and baseline hemoglobin levels ≥ 10g/dL, ORR was 51.5% (n = 47), with median OS of 15.5 months and median PFS of 4.6 months. Similar rates of adverse events were noted in all subgroups.
Conclusions:
Overall, single agent oral selinexor showed strong responses in patients with limited treatment alternatives regardless of germinal center B-cell type or disease origin.
Insights
Oral selinexor demonstrated significant efficacy in treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL), showing strong responses regardless of DLBCL subtype. Patients with normal C-MYC/BCL-2 expression had superior outcomes with selinexor treatment.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Diffuse large B-cell lymphoma (DLBCL) is an aggressive non-Hodgkin lymphoma.
- Relapsed or refractory DLBCL presents significant treatment challenges.
- Oral selinexor offers a potential therapeutic option for patients with limited treatment alternatives.
Purpose of the Study:
- To evaluate the efficacy and tolerability of oral selinexor in patients with relapsed/refractory DLBCL.
- To analyze treatment outcomes based on DLBCL subtypes.
- To investigate the impact of C-MYC and BCL-2 protein expression on selinexor response.
Main Methods:
- Post-hoc analysis of the SADAL study data.
- Inclusion of 134 patients with relapsed/refractory DLBCL.
- Assessment of overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and adverse events by DLBCL subtype and protein expression levels.
Main Results:
- Overall response rate (ORR) was 29.1% in the entire cohort.
- Similar ORR observed between germinal center B-cell (GCB) and non-GCB DLBCL subtypes.
- Patients with normal C-MYC/BCL-2 expression showed significantly higher ORR (46.2%) and longer OS (13.7 months) compared to those with overexpression.
- Adverse events were consistent across subgroups.
Conclusions:
- Single-agent oral selinexor demonstrates notable efficacy in relapsed/refractory DLBCL.
- Treatment response is not significantly influenced by germinal center B-cell type or disease origin.
- C-MYC/BCL-2 protein expression levels are predictive of selinexor efficacy and patient survival.
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