(Liposarcoma) Is Selinexor Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On April 8, 2022, Mrinal M. Gounder et al. from Memorial Sloan Kettering Cancer Center published in the medical journal Journal of Clinical Oncology the efficacy and safety results of XPO1 inhibitor Selinexor in previously treated patients with progressive, metastatic dedifferentiated liposarcoma from the SEAL Phase 2/3 clinical trial.
The SEAL Phase 2/3 trial was a multicenter, double-blind, controlled trial that randomized previously treated patients with progressive, metastatic dedifferentiated liposarcoma (N=285) in a 2:1 ratio into the Selinexor group (60 mg twice daily on a 6-week cycle; N=188) and the placebo group (N=97). The primary endpoint was progression-free survival (PFS); secondary endpoints were time to next treatment and overall survival (OS).
Results: The primary endpoint median PFS was: Selinexor group 2.8 months vs. placebo 2.1 months — a 30% reduction in disease progression and death risk (PFS) compared to placebo.
Secondary endpoints: Median time to next treatment was: Selinexor group 5.8 months vs. placebo 3.2 months — improved compared to placebo. Median OS showed no significant difference between the two groups.
Regarding safety, Grade 3–4 adverse events observed in the majority of patients included: nausea — Selinexor group 80.7% (N=151) vs. placebo 5.9% (N=11); loss of appetite — Selinexor group 60.4% (N=113) vs. placebo 7.5% (N=14); fatigue — Selinexor group 51.3% (N=96) vs. placebo 6.4% (N=12). Mortality rate: Selinexor group 2.1% (N=4) vs. placebo 3.1% (N=3).
Based on SEAL trial results, Mrinal M. Gounder et al. concluded: In previously treated patients with progressive, metastatic dedifferentiated liposarcoma, Selinexor monotherapy improved PFS and time to next treatment compared to placebo.
Source: https://ascopubs.org/doi/full/10.1200/JCO.21.01829
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