A study presented at the 2020 ASH Annual Meeting found that the efficacy of selinexor in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) was similar for both those with a reduced (creatinine clearance [CrCl] <60 mL/min) and normal (CrCl ≥60 mL/min) renal function. “No dose adjustments are required in patients with renal dysfunction and DLBCL who are treated with selinexor,” the researchers noted.
Researchers conducted a post-hoc analysis of the multicenter, open-label, phase IIb SADAL study, which included 134 patients with DLBCL (37 [28%] with reduced baseline CrCl and 97 [72%] with normal CrCl) who received two to five previous lines of therapy. In the SADAL study, patients received selinexor 60 mg twice weekly until disease progression.
Median patient age was 74 years among those with reduced CrCl and 65 years among those with normal CrCl. More patients with reduced CrCl had baseline Eastern Cooperative Oncology Group performance status score of 2 (16% vs. 11%).
Selinexor induced an overall response rate of 29.7% in the reduced CrCl group and 28.9% in the normal CrCl group, with complete responses observed in eight (21.6%) and 10 (10.3%) patients, respectively. The median duration of response was 23.0 months in patients who had reduced CrCl compared with 9.2 months in patients with normal CrCl. Median progression-free survival was 3.5 months (95% confidence interval [CI], 1.7-24.8) and 2.3 months (95% CI, 1.9-3.7), respectively, while overall survival was 7.8 months and 9.1 months, respectively.
The most common grade ≥3 treatment-related adverse events occurring in patients with reduced versus normal CrCl were thrombocytopenia (45.9% vs. 38.1%), nausea (5.4% vs. 6.2%), and fatigue (8.1% vs. 11.3%). There was no clinically significant increase in treatment-related serious AEs (21.6% vs. 20.6%) or AEs leading to discontinuation (10.8% vs. 7.2%) in either cohort.
Reference
Schuster MW, Canales MA, Westin J, et al. Selinexor Efficacy and Safety Are Independent of Renal Function in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL): A Post-Hoc Analysis from the Pivotal Phase 2b Sadal Study. Abstract 1384. Presented at the 62nd American Society of Hematology Annual Meeting & Exposition, December 2-11, 2020.
