KEY TAKEAWAYS
- The XPORT-EC-042 and ENGOT-EN5 phase III trials aimed to evaluate selinexor’s efficacy and safety as maintenance therapy for TP53wt endometrial carcinoma patients responding to platinum-based chemotherapy.
- The primary endpoint is PFS. The secondary endpoint is OS. Selected secondary endpoints are safety assessments and PFS.
In patients with endometrial cancer(EC), TP53 wild-type (TP53wt) is found in about three-quarters of newly diagnosed cases and half of advanced/recurrent tumors. There are currently no targeted therapies available for TP53wt EC patients.
Selinexor, an investigational oral XPO1 inhibitor, has shown promising results in a pre-specified exploratory subgroup of patients with TP53wt EC in the ENGOT-EN5/GOG-3055/SIENDO study.
Researchers aimed to evaluate selinexor’s efficacy and safety as maintenance therapy for TP53wt EC patients responding to platinum-based chemotherapy.
The study focussed on patients with TP53wt primary stage IV or recurrent EC who achieved a partial or complete response per RECIST v1.1 after at least 12 weeks of platinum-based chemotherapy with or without immunotherapy.
Patients must be 18, with histologically confirmed EC and TP53wt tumor by NGS sequencing. They will be randomized 1:1 to receive selinexor 60mg PO or placebo once weekly in 28-day cycles until disease progression, toxicity, or up to 3 years in complete response.
The global enrollment target is 220 patients, and the primary endpoint is progression-free survival(PFS) by investigator-assessed RECIST v1.1. The key secondary endpoint is overall survival(OS); safety assessments and a blinded independent central review for PFS are also included. Patient enrollment is ongoing.
Source: https://www.emma.events/site/programme/?sessiondetail=4534566&trackid=0&a=esgo2023#!
Clinical Trials: https://classic.clinicaltrials.gov/ct2/show/NCT05611931
https://clinicaltrials.gov/study/NCT03555422
Vergote I, Mirza MR, Coleman RJ, Pérez-Fidalgo JA, Monk BJ, Valabrega G, Slomovitz BM, Van Gorp T, Moore K, Sehouli J, Cibula D, Levy T, Aravantinos G, Li K, Kalyanapu P, Makker V; ENGOT-EN20/GOG-3083/XPORT-EC-042 Study Group. A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy for Patients With P53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma.
