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TP010/#397  ENGOT-EN20/GOG-3083/XPORT-EC-042 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
  1. Ignace Vergote1,2,
  2. Mansoor Raza Mirza3,
  3. Robert Coleman4,
  4. Jose Perez Fidalgo5,
  5. Bradley Monk6,
  6. Giorgio Valabrega7,
  7. Brian Slomovitz8,
  8. Toon Van Gorp9,
  9. Kathleen Moore10,
  10. Jalid Sehouli11,
  11. David Cibula12,
  12. Tally Levy13,
  13. Gerassimos Aravantinos14,
  14. Kai Li15,
  15. Pratheek Kalyanapu15 and
  16. Vicky Makker16
  1. 1University Hospitals Leuven, Leuven Cancer Institute,, Oncology, Leuven, Belgium
  2. 2Belgium and Luwembourg Gynaecological Oncology Group (BGOG), Oncology, Leuven, Belgium
  3. 3Rigshospitalet – Copenhagen University Hospital, Oncology, Copenhagen, Denmark
  4. 4GOG-Foundation and Sarah Cannon Research Institute (SCRI), Oncology, Nashville, USA
  5. 5GEICO and Hospital Clinico Universitario de Valencia INCLIVA. CIBERONC, Oncology, Valencia, Italy
  6. 6GOG-Foundation and HonorHealth University of Arizona College of Medicine and Creighton University School of Medicine, Division of Gynecologic Oncology, Phoenix, USA
  7. 7MITO and University of Torino, at Mauriziano Hospital, Department of Oncology, Turin, Italy
  8. 8Mount Sinai Medical Center, Florida International University, Gynecologic Oncology, Miami Beach, USA
  9. 9University Hospitals Leuven, Leuven Cancer Institute, Oncology, Leuven, Belgium
  10. 10University of Oklahoma, Gynecologic Oncology, Oklahoma city, USA
  11. 11NOGGO and European Competence Center for Ovarian Cancer, Charité Comprehensive Cancer Center, Charité-Berlin University of Medicine, Department of Gynecology, Berlin, Germany
  12. 12CEEGOG and First Faculty of Medicine, Charles University and General University Hospital, Oncology, Prague, Czech Republic
  13. 13ISGO and Wolfson Medical Center, Holon, affiliated with Sackler Faculty of Medicine, Tel Aviv University, Gynecologic Oncology Unit, Department of Obstetrics and Gynecology, Tel Aviv, Israel
  14. 14HeCOG and Alexandra Hospital, University of Athens School of Medicine, Department of Clinical Therapeutics, Athens, Greece
  15. 15Karyopharm Therapeutics, Research, Newton, USA
  16. 16Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, USA


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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