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164 Phase 3 recurrent/metastatic cervical carcinoma trial: subgroup efficacy analysis of cemiplimab versus individual investigator’s choice chemotherapy
  1. D Lorusso1,
  2. I Vergote2,
  3. A Oaknin3,
  4. KS Tewari4,
  5. AC De Melo5,
  6. HS Kim6,
  7. YM Kim7,
  8. A Lisyanskaya8,
  9. F Damian9,
  10. CL Chang10,
  11. D Rischin11,
  12. S Takahashi12,
  13. D Ramone13,
  14. J Pikiel14,
  15. EM Guerra Alía15,
  16. J LI16,
  17. S Jamil16,
  18. M Mathias16,
  19. MG Fury16 and
  20. BJ Monk17
  1. 1Fondazione Policlinico Universitario A Gemelli IRCCS and Catholic University of Sacred Heart, Italy
  2. 2University Hospitals, Leuven, KU Leuven, Leuven, Belgium
  3. 3Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  4. 4University of California, Irvine, Irvine, USA
  5. 5Brazilian National Cancer Institute, Rio de Janeiro, Brazil
  6. 6Seoul National University College of Medicine, Seoul, Korea, Rep. of South
  7. 7Asan Medical Center, University of Ulsan, Seoul, Korea, Rep. of South
  8. 8St. Petersburg State Budgetary Institution of Healthcare, St. Petersburg, Russian Federation
  9. 9Hospital Sao Lucas PUCRS, Porto Alegre, Brazil
  10. 10MacKay Memorial Hospital, Taipei, Taiwan
  11. 11Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia
  12. 12The Cancer Institute Hospital of JFCR, Tokyo, Japan
  13. 13Barretos Cancer Hospital (Pio XII Foundation), Barretos, Brazil
  14. 14Szpitale Pomorskie, Gdynia, Poland
  15. 15Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain
  16. 16Regeneron Pharmaceuticals, Inc., Tarrytown, USA
  17. 17Arizona Oncology (US Oncology Network) University of Arizona, Creighton University, Phoenix, USA


Introduction/Background*There is no standard of care regimen in the second-line setting for women with recurrent/metastatic (R/M) cervical carcinoma. Cemiplimab was recently shown to significantly improve overall survival (OS) compared with investigator’s choice (IC) chemotherapy in patients with R/M cervical cancer after first-line platinum-based chemotherapy (NCT03257267; ESMO-VP-2021). We present a pre-planned exploratory subgroup analysis comparing cemiplimab to individual IC chemotherapy options.

Methodology EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 is an open-label, randomised (1:1), multi-centre, Phase 3 clinical trial of anti-programmed cell death (PD)-1 cemiplimab vs IC single agent chemotherapy in R/M cervical cancer that has progressed after first-line platinum-based treatment. The selection of single-agent chemotherapy by the investigator (gemcitabine, pemetrexed, vinorelbine, topotecan or irinotecan) was not protocol-defined, but the regimen had to be chosen prior to randomisation. Adult females (age ≥18 years) were enrolled regardless of PD-ligand 1 expression and received cemiplimab 350 mg intravenously every 3 weeks or IC chemotherapy for up to 96 weeks; and were stratified by histology (squamous cell carcinoma/adenocarcinoma or adenosquamous), geographic region (North America/Asia/rest of world), prior bevacizumab, and ECOG performance status (0/1). Primary endpoint was OS. Additional endpoints included progression-free survival (PFS), objective response rate (ORR), duration of response, quality of life and safety. Data cutoff was 4 January 2021.

Result(s)*A total of 608 patients were randomised: 304 to cemiplimab and 304 to IC chemotherapy (gemcitabine, n=121; premetrexed, n=111; vinorelbine, n=32; topotecan, n=21; irinotecan, n=19) across geographic regions and histologies. Median duration of study follow-up (range) was 4.8 months (0.0–25.9) for the overall population. At second interim analysis, the trial was stopped early for efficacy. OS, PFS and ORR (table 1) demonstrated improvements with cemiplimab vs each IC chemotherapy treatment similar to those observed with cemiplimab vs pooled IC chemotherapy.

Abstract 164 Table 1

Conclusion*Improvements in OS, PFS and ORR with cemiplimab trended consistently with the results for the overall population regardless of IC chemotherapy drug.

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