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O001/#331 Empower-cervical 1/GOG-3016/ENGOT-CX9: results of phase 3 trial of cemiplimab vs investigator’s choice chemotherapy in recurrent/metastatic cervical carcinoma
  1. K Tewari1,
  2. B Monk2,
  3. I Vergote3,
  4. A Miller4,
  5. AC De Melo5,
  6. HS Kim6,
  7. YM Kim7,
  8. A Lisyanskaya8,
  9. V Samouelian9,
  10. D Lorusso10,
  11. F Damian11,
  12. C-L Chang12,
  13. EA Gotovkin13,
  14. S Takahashi14,
  15. D Ramone15,
  16. J Pikiel16,
  17. J Li17,
  18. M Mathias17,
  19. MG Fury17 and
  20. A Oaknin18
  1. 1University of California, Irvine, Division of Gynecologic Oncology, Orange, USA
  2. 2Arizona Oncology (US Oncology Network) University of Arizona, Creighton University, Division of Gynecologic Oncology, Phoenix, USA
  3. 3University Hospitals, Leuven, KU Leuven, Department of Obstetrics and Gynecology and Gynecologic Oncology, Leuven, Belgium
  4. 4Roswell Park Comprehensive Cancer Center, Department of Biostatistics and Bioinformatics, Buffalo, USA
  5. 5Brazilian National Cancer Institute, Division of Clinical Research, Rio de Janeiro, Brazil
  6. 6Seoul National University Hospital, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  7. 7Asan Medical Center, University of Ulsan, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  8. 8St. Petersburg State Budgetary Institution of Healthcare, Department of Gynaecological Oncology, St. Petersburg, Russian Federation
  9. 9CHUM, CRCHUM, Université de Montréal, Gynecology Oncology, Montreal, Canada
  10. 10Fondazione Policlinico Universitario A Gemelli IRCCS and Catholic University of Sacred Heart, Gynaecology Oncology Unit, Rome, Italy
  11. 11Hospital Sao Lucas PUCRS, Gynaecology, Porto Alegre, Brazil
  12. 12MacKay Memorial Hospital, Gynaecology, Taipei, Taiwan
  13. 13State Budget Healthcare Institution Ivanovo Regional Oncology Dispensary, Gynaecology, Ivanovo, Russian Federation
  14. 14The Cancer Institute Hospital of JFCR, Dep. of Medical Oncology, Tokyo, Japan
  15. 15Barretos Cancer Hospital (Pio XII Foundation), Clinical Research Department, Barretos, Brazil
  16. 16Szpitale Pomorskie, Gynaecology, Gdynia, Poland
  17. 17Regeneron Pharmaceuticals, Inc., Clinical Sciences Oncology, Tarrytown, USA
  18. 18Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Gynaecologic Cancer Programme, Barcelona, Spain


Objectives EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 is an open-label, randomized (1:1), multi-center, Phase 3 trial of cemiplimab vs investigator’s choice (IC) chemotherapy (chemo) in recurrent/metastatic (R/M) cervical cancer that has progressed after first-line (1L) platinum-based treatment (tx).

Methods Patients (pts) were enrolled regardless of PD-L1 expression; received cemiplimab 350 mg IV Q3W or IC chemo (pemetrexed, vinorelbine, gemcitabine, irinotecan, or topotecan), up to 96 weeks; and were stratified by histology (squamous cell carcinoma [SCC]/adenocarcinoma or adenosquamous [AC]). Primary endpoint was OS, analyzed hierarchically in pts with SCC followed by total population (SCC + AC). Additional endpoints included PFS, ORR, QoL, and safety. Interim analysis was scheduled when 85% events occurred among SCC pts.

Results 608 pts were randomized: median age, 51 years (range, 22–87); 477 SCC, 131 AC; ECOG performance status: 0 (46.5%), 1 (53.5%). Median cemiplimab exposure was 15 weeks (range, 1.4–100.7). At interim analysis, OS (table 1), PFS, ORR in overall and SCC populations, and mean change from baseline QoL in SCC, favored cemiplimab. Most common tx emergent AEs of any grade for cemiplimab vs IC chemo were anemia (25% vs 45%), nausea (18% vs 33%), and vomiting (16% vs 23%). Discontinuation due to AEs occurred in 8% (cemiplimab) and 5% (IC chemo).

Abstract O001/#331 Table 1

Conclusions Cemiplimab significantly improves OS over single agent chemo for pts with R/M cervical cancer after 1L platinum-based tx regardless of histology and despite not having been selected by PD-L1 status. No new safety signals were observed.

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