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  • PO006LBA/#1520  Selinexor maintenance for patients with TP53WT advanced or recurrent endometrial cancer: long-term follow up of efficacy and safety subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study

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Plenary 02: Changing the Landscape of Endometrial Cancer
AS04. Endometrial/Uterine corpus cancers
PO006LBA/#1520  Selinexor maintenance for patients with TP53WT advanced or recurrent endometrial cancer: long-term follow up of efficacy and safety subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study
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  1. Giovanni Scambia1,
  2. Ignace Vergote2,
  3. Erika Hamilton3,
  4. Jose Perez Fidalgo4,
  5. Toon Van Gorp5,
  6. Jalid Sehouli6,
  7. Jaroslav Klat7,
  8. Tally Levy8,
  9. Stephen Welch9,
  10. Debra Richardson10,
  11. Eva Guerra Alía11,
  12. Stéphanie Henry12,
  13. Pauline Wimberger13,
  14. David Miller14,
  15. Jerónimo Martínez15,
  16. Bradley Monk16,
  17. Pratheek Kalyanapu17,
  18. Mansoor Raza Mirza18 and
  19. Vicky Makker19
  1. 1MITO and Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del S. Cuore, Obstetric and Gynecology, Rome, Italy
  2. 2BGOG and University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium
  3. 3Sarah Cannon Research Institute, Tennessee Oncology, Breast and Gynecologic Cancer Research, Nashville, USA
  4. 4GEICO and Hospital Clinico Universitario de Valencia, Incliva. Ciberonc., Valencia, Spain
  5. 5University Hospitals Leuven, Leuven Cancer Institute, Oncology, Leuven, Belgium
  6. 6NOGGO and European Competence Center for Ovarian Cancer, Charité Comprehensive Cancer Center, Charité-Berlin University of Medicine, Department of Gynecology, Berlin, Germany
  7. 7CEEGOG and University Hospital Ostrava, Oncology, Ostrava, Czech Republic
  8. 8ISGO 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
  9. 9London Health Sciences Centre, Department of Oncology, London, Canada
  10. 10Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Department of Oncology, Oklahoma City, USA
  11. 11GEICO and Hospital Universitario Ramón y Cajal, Department of Oncology, Madrid, Spain
  12. 12BGOG and Université Catholique de Louvain, CHU UCL Namur Site Ste Elisabeth, Service d’onco-hématologie (SORMN), Department of Oncology, Namur, Belgium
  13. 13NOGGO and Technische Universität Carl Gustav Carus Dresden, Department of Gynecology and Obstetrics, Dresden, Germany
  14. 14Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Department of Obstetrics and Gynecology, Dallas, USA
  15. 15GEICO and Hospital Universitario Virgen de la Arrixaca, Department of Oncology, Murica, Spain
  16. 16GOG-Foundation and HonorHealth University of Arizona College of Medicine and Creighton University School of Medicine, Division of Gynecologic Oncology, Phoenix, USA
  17. 17Karyopharm Therapeutics, Research, Newton, USA
  18. 18Rigshospitalet – Copenhagen University Hospital, Oncology, Copenhagen, Denmark
  19. 19Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, USA

Abstract

Introduction Molecular characterization is important to inform treatment decisions for patients with endometrial cancer (EC). Wild type TP53 (TP53wt) is found in ~50% of advanced/recurrent EC and of those, ~70% are microsatellite stable (MSS/pMMR).

Methods ENGOT-EN5/GOG-3055/SIENDO (NCT03555422) is a randomized double-blind, phase 3 trial evaluating selinexor vs placebo as a maintenance treatment for advanced/recurrent EC following response to prior systemic therapy. Here we report the updated efficacy and safety of a prespecified exploratory subgroup analysis of patients with TP53wt EC.

Results 113 patients with TP53wt EC received selinexor (n=77) or placebo (n=36) as maintenance therapy. As of March 2023, the median follow-up was 25.3 months, and 26 patients remain on treatment. Median PFS (mPFS) was 27.4 months with selinexor vs 5.2 months with placebo (HR 0.42; 95% CI [0.25–0.70], nominal one-sided p=0.0003). PFS improvement was observed regardless of microsatellite instability status; in the TP53wt/MSS(pMMR) subgroup, the mPFS was not reached with selinexor vs 4.9 months with placebo. In patients with TP53wt, the most common adverse events (AEs) were nausea, vomiting, and diarrhea; most common grade ≥3 AEs were neutropenia, thrombocytopenia, and nausea; 16% of patients discontinued selinexor due to AEs. No grade 5 AEs occurred. No immune-related AEs were observed.

Abstract PO006LBA/#1520 Figure 1
Abstract PO006LBA/#1520 Figure 1

Conclusion/Implications TP53wt status may represent a robust predictive biomarker for selinexor efficacy in EC. Additionally, a strong PFS signal was observed in the TP53wt/MSS(pMMR) subgroup, a patient population with high unmet need. Both additional data and updated data will be presented at the conference.

https://doi.org/10.1136/ijgc-2023-IGCS.6

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