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O003/#149 Antitumor activity of dostarlimab in patients with advanced or recurrent mismatch repair–deficient or proficient–cancer by prior therapy: results from the garnet study
  1. A Oaknin1,
  2. L Gilbert2,
  3. A Tinker3,
  4. J Brown4,
  5. C Mathews5,
  6. J Press6,
  7. R Sabatier7,
  8. D O’Malley8,
  9. V Samouëlian9,
  10. V Boni10,
  11. L Duska11,
  12. S Ghamande12,
  13. P Ghatage13,
  14. R Kristeleit14,
  15. C Leath Iii15,
  16. J Veneris16,
  17. T Duan17,
  18. E Im18 and
  19. B Pothuri19
  1. 1Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Department of Medical Oncology, Barcelona, Spain
  2. 2McGill University Health Centre-RI, Gynecologic Oncology Division, Montreal, Canada
  3. 3BC Cancer, Department of Medical Oncology/department of Medicine, Vancouver, Canada
  4. 4Levine Cancer Institute, Atrium Health, Division of Gynecologic Oncology, Charlotte, USA
  5. 5Women and Infants Hospital of Rhode Island, Gynecologic Oncology, Providence, USA
  6. 6Swedish Cancer Institute Gynecologic Oncology and Pelvic Surgery, Gynecologic Oncology and Pelvic Surgery, Seattle, USA
  7. 7Institut Paoli Calmettes, Aix-Marseille University, Department of Medical Oncology, Marseille, France
  8. 8The Ohio State University – James CCC, Department of Obstetrics and Gynecology, Columbus, USA
  9. 9Gynecologic Oncology Service, CHUM, Université de Montréal, Department of Obstetrics and Gynecology, Montreal, Canada
  10. 10START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Hospital Universitario HM Sanchinarro, Early Drug Development Unit, Medical Oncology, Madrid, Spain
  11. 11Emily Couric Clinical Cancer Center, University of Virginia, Department of Obstetrics and Gynecology, Charlottesville, USA
  12. 12Georgia Cancer Center, Augusta University, Gynecologic Oncology, Augusta, USA
  13. 13University of Calgary, Department of Gynecological Oncology, Calgary, Canada
  14. 14Guy’s and St Thomas’ Hospital NHS Foundation Trust, Medical Oncology, London, UK
  15. 15O’Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Division of Gynecologic Oncology, Birmingham, USA
  16. 16GlaxoSmithKline, Oncology Clinical Department, Waltham, USA
  17. 17GlaxoSmithKline, Oncology Clinical Statistics, Waltham, USA
  18. 18GlaxoSmithKline, Clinical Development, Waltham, USA
  19. 19New York University, NYU Langone Health, Perlmutter Cancer Center, Department of Obstetrics and Gynecology, New York, USA


Objectives Dostarlimab is a humanized programmed death 1 (PD-1) receptor monoclonal antibody that blocks interactions with PD-1 ligands. GARNET is a phase 1 study assessing antitumor activity and safety of dostarlimab monotherapy in patients with advanced solid tumors.

Methods This multicenter, open-label, single-arm study is conducted in 2 parts: dose escalation and expansion. Patients with advanced or recurrent mismatch repair–deficient (dMMR) or microsatellite instability–high (MSI-H) endometrial cancer (EC) or mismatch repair–proficient (MMRp) EC that progressed on or after a platinum regimen received dostarlimab 500 mg intravenously Q3W for 4 cycles, then 1000 mg Q6W until disease progression or discontinuation. Primary endpoints were objective response rate (ORR) and duration of response by BICR using RECIST v1.1. Here we report ORR in dMMR/MSI-H and MMRp EC by prior lines of therapy (LOTs).

Results Efficacy analyses included 108 dMMR/MSI-H and 142 MMRp patients. ORR was 43.5% in dMMR/MSI-H and 13.4% in MMRp. ORR was slightly higher (47.8%) in patients with dMMR/MSI-H with 1 prior LOT but lower (35.9%) in those who received ≥2 prior LOTs. In the MMRp population, ORR was similar, regardless of prior LOTs. Safety has been previously reported.1

Abstract O003/#149 Table 1

Conclusions Dostarlimab demonstrated antitumor activity in recurrent or advanced dMMR/MSI-H and MMRp EC regardless of number of prior LOTs. Patients with dMMR/MSI-H EC who received 1 prior LOT had slightly higher ORR than those who received ≥2 prior LOTs. 1. Oaknin A, et al. Ann Oncol 2020;31(suppl 4):S1142–S1215.

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