Article Text

Download PDFPDF

2022-RA-1297-ESGO A subgroup analysis of response rate by patient characteristics in patients with endometrial cancer receiving monotherapy dostarlimab in the GARNET trial
Free
  1. Ana Oaknin1,
  2. Bhavana Pothuri2,
  3. Lucy Gilbert3,
  4. Renaud Sabatier4,
  5. Jubilee Brown5,
  6. Sharad Ghamande6,
  7. Cara Mathews7,
  8. David M O’Malley8,
  9. Rebecca Kristeleit9,
  10. Valentina Boni10,
  11. Adriano Gravina11,
  12. Susana Banerjee12,
  13. Rowan E Miller13,
  14. Joanna Pikiel14,
  15. Mansoor R Miza15,
  16. Tao Duan16,
  17. Yuping Dong16,
  18. Eleftherios Zografos17,
  19. Jennifer Veneris18,
  20. Anna V Tinker19,
  21. NEXT Oncology Hospital Universitario Quirónsalud *Affiliation at time of study. Current affiliation
  1. 1Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  2. 2Department 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, Atrium Health, 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 Oncology and Gynecologic Oncology Phase I Program, The Ohio State University and the James Cancer Center, Columbus, OH
  9. 9Guy’s and St. Thomas’ Hospital NHS Foundation Trust, London, United Kingdom
  10. 10START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Hospital Universitario HM Sanchinarro, Madrid, Spain
  11. 11Clinical Trial Unit, Istituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy
  12. 12Gynaecology Unit, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom
  13. 13University College London, St. Bartholomew’s Hospitals London, London, United Kingdom
  14. 14Department of Chemotherapy, Regional Center of Oncology, Gdansk, Poland
  15. 15Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Denmark and Nordic Society of Gynaecologic Oncology-Clinical Trial Unit, Copenhagen, Denmark
  16. 16GSK, Pennington, NJ
  17. 17GSK, London, United Kingdom
  18. 18GSK, Waltham, MA
  19. 19Department of Medicine, British Columbia Cancer, Vancouver Centre, University of British Columbia, Vancouver, BC, Canada

Abstract

Introduction/Background Clinical characteristics of patients have demonstrated that there may be independent predictors of response to cancer drug therapies. In this analysis, we evaluated objective response rate (ORR) by subgroups of clinical characteristics in patients with advanced or recurrent endometrial cancer who were treated with the anti-PD-1 dostarlimab.

Methodology GARNET is a multicentre, open-label, single-arm phase 1 study. Patients were assigned to cohort A1 (mismatch repair deficient [dMMR]/microsatellite instability-high [MSI-H EC]) or A2 (mismatch repair proficient [MMRp]/microsatellite stable [MSS] EC) based on immunohistochemistry assessment. Patients received 500 mg of dostarlimab IV every 3 weeks for 4 cycles, then 1000 mg every 6 weeks until disease progression, discontinuation, or withdrawal. Patient baseline demographics (age and BMI), histology, and prior lines of therapies were collected for enrolled patients. ORR by BICR per RECIST v1.1 for prior lines of therapy and histology were pre-specified exploratory subgroup analyses, whereas age and BMI were post hoc subgroup analyses.

Results 153 patients with dMMR/MSI-H and 161 patients with MMRp/MSS EC were enrolled and treated. The efficacy-evaluable population included 143 patients with dMMR/MSI-H EC and 156 patients with MMRp/MSS EC with measurable disease at baseline and the opportunity for at least 6 months of follow-up. ORR for each subgroup (age, BMI, prior lines of therapy, and histology) in each cohort were similar to that of the ORR for each overall cohort (see table 1). Overlapping 95% CIs are observed for all the subgroups assessed.

Abstract 2022-RA-1297-ESGO Table 1

Subgroup analysis by patients characteristics

Conclusion The treatment benefit of dostarlimab was consistent across clinical characteristic subgroups on a per-cohort basis (dMMR/MSI-H response rates were consistently ≥40%, whereas MMRp/MSS response rates were between 8% and 20%). No correlation could be made between response rate and individual clinical characteristics. Given the small sample size of the subgroups, caution should be used when interpreting the results.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.