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  • 2022-RA-653-ESGO The impact of histology, prior therapy, and dMMR status on lenvatinib + pembrolizumab outcomes in patients with advanced endometrial cancer: A subgroup analysis of Study 309/KEYNOTE-775

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Endometrial cancer
2022-RA-653-ESGO The impact of histology, prior therapy, and dMMR status on lenvatinib + pembrolizumab outcomes in patients with advanced endometrial cancer: A subgroup analysis of Study 309/KEYNOTE-775
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  1. Domenica Lorusso1,
  2. Vicky Makker2,
  3. Antonio Casado Herraez3,
  4. Bradley J Monk4,
  5. Helen Mackay5,
  6. Alessandro D Santin6,
  7. David S Miller7,
  8. Richard Moore8,
  9. Sally Baron-Hay9,
  10. Isabelle Ray-Coquard10,
  11. Ronnie Shapira-Frommer11,
  12. Kimio Ushijima12,
  13. Kan Yonemori13,
  14. Yong Man Kim14,
  15. Eva M Guerra Alia15,
  16. Ulus A Sanli16,
  17. Jie Huang17,
  18. Jodi McKenzie18,
  19. Gianmaria Barresi19 and
  20. Nicoletta Colombo20
  1. 1Division of Gynecologic Oncology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy
  2. 2Medical Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
  3. 3Medical Oncology Department, Hospital Clinico Universitario San Carlos, Madrid, Spain
  4. 4HonorHealth Research Institute, University of Arizona, Creighton University, Phoenix, AZ
  5. 5Medical Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
  6. 6Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT
  7. 7Division of Gynecologic Oncology, University of Texas Southwestern Medical Center, Dallas, TX
  8. 8Division of Gynecologic Oncology, University of Rochester Medical Center, Rochester, NY
  9. 9Medical Oncology Department, Royal North Shore Hospital, St. Leonards, NSW, Australia
  10. 10Medical Oncology Department, Centre Léon Bérard, University Claude Bernard, GINECO Group, Lyon, France
  11. 11Oncology Department, Sheba Medical Center, Ramat, Israel
  12. 12Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Japan
  13. 13Department of Medical Oncology, National Cancer Center Hospital, Chuo-ku, Japan
  14. 14Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan, Seoul, Korea, Republic of
  15. 15Department of Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, Spain
  16. 16Individualized Medicine Application and Research Center and Department of Medical Oncology, Ege University, Izmir, Turkey
  17. 17Biostatistics, Eisai Inc., Nutley, NJ
  18. 18Oncology Business Group, Eisai Inc., Nutley, NJ
  19. 19MSD Austria, Vienna, Austria
  20. 20Gynecologic Oncology Department, University of Milan-Bicocca, European Institute of Oncology IRCCS, Milan, Italy

Abstract

Introduction/Background In the phase 3 Study 309/KEYNOTE-775 (Makker 2022, NEJM), lenvatinib plus pembrolizumab (L+P) demonstrated statistically and clinically significant improvements in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) versus treatment of physician’s choice (TPC) in previously treated advanced endometrial cancer (aEC; in mismatch-repair proficient [pMMR] and all-comer patients). In this updated analysis (data cutoff: March 1, 2022), we report efficacy by histology, prior therapy, and deficient (d)MMR status.

Methodology Pts with aEC and 1 prior platinum-based chemotherapy regimen (up to 2 if 1 was given in the neoadjuvant/adjuvant setting) were randomized (1:1) to L 20 mg orally once daily + P 200 mg IV every 3 weeks (Q3W) or TPC (doxorubicin at 60 mg/m2 IV Q3W or paclitaxel at 80 mg/m2 IV QW [3 weeks on; 1 week off]). Randomization was stratified by MMR status; pMMR patients were further stratified by Eastern Cooperative Oncology Group Performance Status, geographic region, and history of pelvic irradiation. We report PFS, OS, and ORR (by blinded independent central review per RECIST v1.1) by histology (endometrioid vs non-endometrioid), prior therapy (1, 2, ≥3 lines), and dMMR status.

Results 827 patients were randomized to L+P (n=411) or TPC (n=416). PFS and OS in all-comers favored L+P regardless of histology (PFS HR, endometrioid: 0.54/non-endometrioid: 0.55; OS HR, endometrioid: 0.63/non-endometrioid: 0.61), prior therapy (PFS HR: 1 line, 0.49/2 lines, 0.68/≥3 lines, 0.61; OS HR: 1 line, 0.63/2 lines, 0.64/≥3 lines, 0.69), or dMMR status (PFS HR, 0.39; OS HR, 0.43) (table 1). The table 1 also shows PFS, OS, and ORR in all-comers and pMMR patients.

View this table:
Abstract 2022-RA-653-ESGO Table 1

Conclusion PFS, OS, and ORR continued to favor L+P vs TPC in all subgroups of interest, including patients with dMMR tumors. These data further support L+P as a standard therapy in previously treated aEC.

https://doi.org/10.1136/ijgc-2022-ESGO.223

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