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#540 Safety of dostarlimab in combination with chemotherapy in patients with primary advanced or recurrent endometrial cancer in a phase 3, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY)
  1. Annika Auranen1,
  2. Destin Black2,
  3. Vladyslav Sukhin3,
  4. Sudarshan Sharma4,
  5. Graziana Ronzino5,
  6. Lisa M Landrum6,
  7. Dirk Bauerschlag7,
  8. Lyndsay Willmott8,
  9. Roy Lalisang9,
  10. Joseph Buscema10,
  11. Lucy Gilbert11,
  12. Robert L Coleman12,
  13. David Bender13,
  14. Amy Armstrong14,
  15. Nicole Nevadunsky15,
  16. Matthew A Powell16,
  17. Christine Dabrowski17,
  18. Shadi Stevens18,
  19. Mansoor Raza Mirza19 and
  20. Evelyn Fleming20
  1. 1Tays Cancer Centre and FICAN Mid, Tampere University and Tampere University Hospital, Tampere, Finland
  2. 2Department of Obstetrics and Gynecology, LSU Health Shreveport, and Willis-Knighton Physician Network, Shreveport, USA
  3. 3Grigoriev Institute for Medical Radiology and Oncology, NAMS, Kharkiv, Ukraine
  4. 4Department of Obstetrics/Gynecology, AMITA Adventist Hinsdale Hospital, Hinsdale, USA
  5. 5Oncology Unit, Vito Fazzi Hospital, Lecce, Italy
  6. 6Indiana University Health and Simon Cancer Center, Indianapolis, USA
  7. 7University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
  8. 8Arizona Center for Cancer Care, Phoenix, USA
  9. 9Department of Internal Medicine, Maastricht UMC Comprehensive Cancer Center, GROW-School of Oncology and Reproduction, Maastricht University Medical Center, Maastricht, The Netherlands
  10. 10Department of Gynecologic Oncology, Arizona Oncology, Tucson, USA
  11. 11Division of Gynecologic Oncology, McGill University Health Centre, Montreal, Canada
  12. 12Sarah Cannon Research Institute, Nashville, USA
  13. 13Department of Obstetrics and Gynecology, University of Iowa, Iowa City, USA
  14. 14University Hospitals Research Institute and HCA Healthcare UK, London, UK
  15. 15Department of Obstetrics, Gynecology, and Women’s Health, Montefiore Medical Center, Bronx, USA
  16. 16National Cancer Institute-sponsored NRG Oncology, Washington University School of Medicine, St Louis, USA
  17. 17GSK, Waltham, USA
  18. 18GSK, London, UK
  19. 19Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, and Nordic Society of Gynaecologic Oncology-Clinical Trial Unit, Copenhagen, Denmark
  20. 20Division of Gynecologic Oncology, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, USA


Introduction/Background In the phase 3 RUBY trial (NCT03981796) in patients with primary advanced or recurrent endometrial cancer (pA/rEC) dostarlimab+carboplatin/paclitaxel significantly improved PFS versus carboplatin/paclitaxel alone in the mismatch repair deficient/microsatellite instability-high (HR 0.28) and overall populations (HR 0.64) with a favourable OS trend (HR 0.64). Here, we report on safety for the RUBY trial.

Methodology Patients with pA/rEC were randomised 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. Adverse events (AEs) were assessed according to CTCAE v4.03.

Results The safety population included 487 patients who received ≥1 dose of treatment (241 dostarlimab+carboplatin/paclitaxel; 246 placebo+carboplatin/paclitaxel). Treatment-emergent adverse events (TEAEs) were experienced by 100% of patients; 70.5% of the dostarlimab arm and 59.8% of the placebo arm experienced grade ≥3 TEAEs (table 1). Median time to TEAE was 2.0 days in the dostarlimab+carboplatin/paclitaxel arm and 2.5 days in the placebo+carboplatin/paclitaxel arm. TEAEs led to discontinuation in 23.7% of the dostarlimab+carboplatin/paclitaxel arm and 16.7% of the placebo+carboplatin/paclitaxel arm. Higher rates of discontinuation were reported during the chemotherapy phase (cycles 1–6) versus the monotherapy phase (cycles ≥7). TEAEs led to discontinuation of dostarlimab or placebo in 17.4% and 9.3% of patients (table 1). Discontinuation rates of carboplatin or paclitaxel were similar between arms. Immune-related AEs related to dostarlimab or placebo were reported in 38.2% of the dostarlimab arm and 15.4% of the placebo arm. Five deaths were reported in the dostarlimab arm; 2 were related to dostarlimab.

Conclusion The safety profile of dostarlimab+carboplatin/paclitaxel was consistent with that of the individual components. The addition of dostarlimab did not compromise the completion rate of chemotherapy. Dostarlimab+carboplatin/paclitaxel has a favourable benefit-risk profile that makes it a valuable treatment option for patients with pA/rEC.

Disclosures This study (NCT03981796) was sponsored by GSK, Waltham, MA, USA.

Abstract #540 Table 1

Third-party medical writing support Writing and editorial support, funded and coordinated by GSK (Waltham, MA, USA), was provided by Shannon Morgan-Pelosi, PhD, and Mary Wiggin of Ashfield MedComms, an Inizio company.

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