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2022-RA-1009-ESGO Immune-related endpoints in patients with advanced or recurrent endometrial cancer treated with dostarlimab in the GARNET study
  1. Anna V Tinker1,
  2. Bhavana Pothuri2,
  3. Lucy Gilbert3,
  4. Renaud Sabatier4,
  5. Jubilee Brown5,
  6. Sharad Ghamande6,
  7. Cara Mathews7,
  8. David M O’Malley8,
  9. Valentina Boni9,
  10. Adriano Gravina10,
  11. Susana Banerjee11,
  12. Rowan E Miller12,
  13. Johanna Pikiel13,
  14. Mansoor R. Mirza14,
  15. Tao Duan15,
  16. Sybil Zildjian16,,
  17. Eleftherios Zografos17,
  18. Jennifer Veneris16,
  19. Ana Oaknin18,
  20. study was START Madrid CIOCC
  1. 1Department of Medicine, British Columbia Cancer, Vancouver Centre, University of British Columbia, Vancouver, BC, Canada
  2. 2Gynecologic Oncology Group (GOG) and Department of Obstetrics/Gynecology, Laura & Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY
  3. 3Division of Gynecologic Oncology, McGill University Health Centre, Montreal, QC, Canada
  4. 4Department of Medical Oncology, Institut Paoli Calmettes, Aix-Marseille University, Marseille, France
  5. 5Division of Gynecologic Oncology, Levine Cancer Institute, Carolinas HealthCare System, Charlotte, NC
  6. 6Department of Obstetrics & Gynecology, Georgia Cancer Center, Augusta University, Augusta, GA
  7. 7Women and Infants Hospital of Rhode Island, Providence, RI
  8. 8Division of Gynecologic Oncology and Gynecologic Oncology Phase I Program, The Ohio State University and the James Cancer Center, Columbus, OH
  9. 9NEXT Oncology Hospital Universitario Quirónsalud Madrid, Madrid, Spain
  10. 10Clinical Trial Unit, Istituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy
  11. 11Gynaecology Unit, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom
  12. 12University College London, St. Bartholomew’s Hospitals London, London, United Kingdom
  13. 13Department of Chemotherapy, Regional Center of Oncology, Gdansk, Poland
  14. 14Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Denmark, Nordic Society of Gynaecologic Oncology-Clinical Trial Unit, Copenhagen, Denmark
  15. 15GSK, Pennington, NJ
  16. 16GSK, Waltham, MA
  17. 17GSK, London, United Kingdom
  18. 18Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  19. *Current affiliation; affiliation at the time of s, ed. †Employed by GSK at the time the study was conduct


Introduction/Background Dostarlimab is a programmed death 1 (PD-1) inhibitor approved in the US as monotherapy in patients with mismatch repair deficient (dMMR) advanced/recurrent endometrial cancer (EC) that has progressed on or after platinum-based chemotherapy or dMMR solid tumours that have progressed on or after prior treatment, with no satisfactory alternative treatment options; and in the EU as monotherapy in patients with dMMR/microsatellite instability-high (MSI-H) advanced/recurrent EC that has progressed on or after platinum-based chemotherapy. We report efficacy endpoints by immune-related RECIST (irRECIST) per investigator assessment (IA) for the EC cohorts of the GARNET trial.

Methodology GARNET is a multicentre, open-label, single-arm phase 1 study. Assignment to cohort A1 (dMMR/MSI-H EC) or A2 (mismatch repair proficient [MMRp]/microsatellite stable [MSS] EC) was based on local assessment. Patients received 500 mg of dostarlimab intravenously Q3W for 4 cycles, then 1000 mg Q6W until disease progression, discontinuation, or withdrawal. Immune-related endpoints (irORR, irDOR, and irPFS) were prespecified secondary endpoints.

Results The irRECIST efficacy-evaluable population included 152 patients with dMMR/MSI-H EC and 160 patients with MMRp/MSS EC with measurable disease at baseline and ≥6 months’ follow-up per IA. irORR and irDOR were similar to the primary endpoints of ORR and DOR by BICR per RECIST v1.1 (table 1). For dMMR/MSI-H, median irPFS was 11.2 mo versus median PFS of 6.0 mo, although the probability of remaining progression free at 6, 12, or 18 mo was similar. Safety was previously reported.

Abstract 2022-RA-1009-ESGO Table 1

Conclusion In line with the study primary endpoints, secondary efficacy endpoints by irRECIST demonstrate the benefit of dostarlimab in patients with EC.

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