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Presentation transcript:

Participating groups: A randomized phase III trial of maintenance with Selinexor/ placebo after combination chemotherapy for patients with advanced or recurrent endometrial cancer. Participating groups: BGOG (Belgium, sponsor) NSGO (Nordic Society of Gynecologic Oncology) GINECO (France) MITO (Italy), Candiolo Coordinator of 8 centers AGO and NOGGO (Germany) SAKK (Switzerland) HECOG (Greece) PI: Ignace Vergote, BGOG

Background and Rationale (1) Advanced/recurrent Endometrial Cancer is still a lethal disease > new drugs are needed

Exportin 1 XPO1 is frequently overexpressed in endometrial cancer Background and Rationale (2) Exportin 1 XPO1 is frequently overexpressed in endometrial cancer Selinexor (KPT-330), is a novel, oral small-molecule inhibitor of exportin 1 (XPO1/CRM1) which impairs its activity of exporting out of the nucleus proapoptotic factors therefore inducing apoptosis

Clinical activity in endometrial cancer: The phase II SIGN trial (Endometrial Cancer cohort) 23 Endometrial Cancers (median previous treatments 2 (1–5) DCR: 43%; ORR: 14%;. Median PFS : 12 wks ; 2 EC on SEL treatment >6 mos. Toxicities: Grade 1/2 drug-related adverse events (AEs) included: nausea (56%), anorexia (47%), weight loss (44%) & fatigue (42%). Grade 3 drug related AEs included: thrombocytopenia (11%), fatigue (10%), anemia (9%) , nausea (8%). Grade 4 AEs were cataract (1pt) & hyponatremia (1pt). Vergote et al ESMO 2016

Study Design Oral Selinexor 80 mg/weekly Until progression Key inclusion criteria Endometrial cancer (carcinosarcoma is allowed also) No more than 2 lines for metastatic disease Must have received carboplatin paclitaxel earlier PR or CR after last Carboplatin and Taxane Tumor material available Oral Selinexor 80 mg/weekly Until progression Placebo 80 mg weekly Primary endpoint: PFS Secondary: PFS2 (successive treatment), OS, Exploratory (ctDNA, plasma) Patients: 126 (63 for each ARM) MITO target: ?