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PR038/#248  Management of immune-related adverse events in patients with primary advanced or recurrent endometrial cancer: dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial
  1. Zoltan Novák1,
  2. Michael Gold2,
  3. Jørn Herrstedt3,
  4. Sarah Gill4,
  5. Antonella Savarese5,
  6. John Diaz6,
  7. Stefan Kommoss7,
  8. Guilherme Cantuaria8,
  9. Ingrid Boere9,
  10. Evelyn Fleming10,
  11. Lucy Gilbert11,
  12. Kathryn Pennington12,
  13. Robert Holloway13,
  14. Eirwen Miller14,
  15. Rachel Miller15,
  16. Matthew Powell16,
  17. Christine Dabrowski17,
  18. Shadi Stevens18,
  19. Mansoor Raza Mirza19 and
  20. Carolyn Mccourt20
  1. 1Hungarian National Institute of Oncology, Department of Gynecology, Budapest, Hungary
  2. 2Oklahoma Cancer Specialists and Research Institute, Department of Gynecologic Oncology, Tulsa, USA
  3. 3Zealand University Hospital Roskilde and University of Copenhagen, Department of Clinical Oncology and Palliative Care, Copenhagen, Denmark
  4. 4Nancy N and JC Lewis Cancer and Research Pavilion, Division of Gynecologic Oncology, Savannah, USA
  5. 5IRCCS Istituti Fisioterapici Ospitalieri, Istituto Nazionale Tumori Regina Elena, Department of Medical Oncology, Rome, Italy
  6. 6Miami Cancer Institute at Baptist Health South Florida, Chief of Gynecologic Oncology, Miami, USA
  7. 7AGO Study Group, University Hospital Tübingen, Department of Women’s Health, Tübingen, Germany
  8. 8Georgia NCORP, Department of Gynecologic Oncology, Atlanta, USA
  9. 9Erasmus MC Cancer Centre, Department of Medical Oncology, Rotterdam, Netherlands
  10. 10Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Division of Gynecologic Oncology, Lebanon, USA
  11. 11McGill University Health Centre, Division of Gynecologic Oncology, Montreal, Canada
  12. 12University of Washington, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Seattle, USA
  13. 13Advent Health Cancer Institute, Gynecologic Oncology Program, Orlando, USA
  14. 14Western Pennsylvania Hospital, Allegheny Health Network, Division of Gynecologic Oncology, Pittsburgh, USA
  15. 15University of Kentucky Markey Cancer Center, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Lexington, USA
  16. 16Washington University School of Medicine, National Cancer Institute Sponsored Nrg Oncology, St Louis, USA
  17. 17GSK, Clinical Safety, Waltham, USA
  18. 18GSK, Oncology Clinical Development, London, UK
  19. 19Rigshospitalet, Copenhagen University Hospital, Copenhagen, and Nordic Society of Gynaecological Oncology-Clinical Trial Unit, Department of Oncology, Copenhagen, Denmark
  20. 20Washington University School of Medicine, Washington University in St. Louis, Division of Gynecologic Oncology, St. Louis, USA


Introduction Dostarlimab+carboplatin-paclitaxel demonstrated PFS and OS benefits vs carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer (pA/rEC). Here, we report on the management of immune-related adverse events (irAEs) in the RUBY (NCT03981796) trial.

Methods Patients with pA/rEC were randomized 1:1 to dostarlimab 500 mg, or placebo, plus carboplatin AUC 5 and paclitaxel 175 mg/m2 Q3W for 6 cycles, followed by dostarlimab 1000 mg, or placebo, Q6W for up to 3 years. AEs were assessed according to CTCAE v4.03. irAEs were defined as CTCAE grade ≥2 from a predefined list.

Results The safety population included 487 patients who received ≥1 dose of treatment (241 dostarlimab+carboplatin-paclitaxel; 246 placebo+carboplatin-paclitaxel). irAEs related to dostarlimab or placebo were reported by 38.2% in the dostarlimab+carboplatin-paclitaxel arm and 15.4% in the placebo+carboplatin-paclitaxel arm; grade ≥3 irAEs related to dostarlimab or placebo were reported by 12.4% and 3.3%, respectively (table 1). Only 7.9% and 3.7% of patients discontinued dostarlimab or placebo because of an irAE, respectively; there were no irAE-related deaths. Of those experiencing irAEs in the dostarlimab+carboplatin-paclitaxel arm, 63.5% were treated with steroids, immunosuppressants, and/or thyroid therapy; 73.6% resolved (median resolution 10.0 days). Of the 36.5% patients not receiving steroids, immunosuppressants, and/or thyroid therapy, 80.0% resolved (median resolution 8.0 days). Management and resolution frequency were similar in the placebo+carboplatin-paclitaxel arm (table 1).

Conclusion/Implications In the RUBY trial, most irAEs were mild and resolved. Few patients discontinued dostarlimab because of irAEs. The irAE profile observed in the dostarlimab+carboplatin-paclitaxel arm showed similar trends as that observed with dostarlimab monotherapy.

Abstract PR038/#248 Table 1

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