ENGOT-EN20/GOG-3083/xport-EC-042: A phase 3, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with P53 wild-type, advanced or recurrent endometrial carcinoma
JOURNAL OF CLINICAL ONCOLOGY(2023)
Abstract
First-line treatment of patients with metastatic/recurrent endometrial cancer (EC) generally results in finite disease control with an overall poor prognosis with limited approved maintenance therapies. Molecular characterization of EC is critical to inform treatment. Of the molecular subtypes, 45–50% EC and 30% advanced and recurrent tumors are p53 wild type (wt). Selinexor (SEL) inhibits XPO1 resulting in nuclear accumulation of p53, and shows clinical activity in previously treated, advanced EC. A preliminary analysis of a pre-specified exploratory subgroup with advanced or first-line recurrent p53 wt EC in the ENGOT-EN5/GOG-3055/SIENDO study (NCT03555422) revealed potential clinical benefit of SEL with a generally manageable safety profile.
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Key words
recurrent endometrial carcinoma,p53,selinexor,placebo-controlled,double-blind,wild-type
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