Introduction Selinexor is FDA-approved for use in multiple myeloma and diffuse large B-cell lymphoma. In the ENGOT-EN5/GOG-3055/SIENDO study (NCT03555422), preliminary analysis of a pre-specified exploratory subgroup of patients with TP53wt EC showed a decrease in risk for progression or death with a median PFS of 13.7 months with selinexor vs 3.7 months with placebo. of the EC molecular subtypes, TP53 wild type (wt) tumors represent 50% of advanced and recurrent tumors.
Methods XPORT-EC-042 (NCT05611931) is a phase 3 randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of selinexor as maintenance therapy in patients with TP53wt primary stage IV or recurrent EC, who achieved a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 after completing at least 12 weeks of platinum combination chemotherapy±immunotherapy. Among other inclusion/exclusion criteria, eligible patients must be ≥18 years of age, have histologically confirmed EC, and TP53wt tumor confirmed by NGS sequencing. Patients will be randomized 1:1 with selinexor 60 mg or placebo once-weekly in 28-day cycles until progressive disease, toxicity, or 3-years if in complete response. A total of 220 patients are estimated to be enrolled globally. The primary endpoint is PFS based on RECIST v1.1 criteria as assessed by the Investigator. The key secondary endpoint is overall survival. Select secondary endpoints include safety assessments and PFS assessed by a blinded independent central review.
Current Trial Status Patient enrollment is ongoing.
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