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2022-RA-1144-ESGO Management of immune-related adverse events in patients with solid tumours treated with dostarlimab in the GARNET study
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  1. Dominique Berton1,
  2. Thierry Andre2,
  3. Ana Oaknin3,
  4. Victor Moreno4,
  5. José Trigo5,
  6. Giuseppe Curigliano6,
  7. Anna V Tinker7,
  8. Valentina Boni8,
  9. Maria Pillar Barretina-Ginesta9,
  10. Joanna Pikiel10,
  11. Bhavana Pothuri11,
  12. Mansoor R Mirza12,
  13. Petra Panovcova13,
  14. Tao Duan14,
  15. Christine Dabrowski15,
  16. Christine Dabrowski16,
  17. Eleftherios Zografos15,
  18. Jennifer Veneris17,
  19. NEXT Oncology Hospital Universitario Quirónsalud *Affiliation at time of study. Current affiliation
  1. 1GINECO and Institut de Cancerologie de l’Ouest, Centre René Gauducheau, Saint-Herblain, France
  2. 2Sorbonne University and Saint-Antoine Hospital, Paris, France
  3. 3Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  4. 4START Madrid-FJD, Fundación Jiménez Diaz Hospital, Madrid, Spain
  5. 5Medical Oncology Department, Hospital Virgen de la Victoria IBIMA, Malaga, Spain
  6. 6Division of Early Drug Development for Innovative Therapies, European Institute of Oncology IRCCS, and University of Milano, Milan, Italy
  7. 7Department of Medicine, British Columbia Cancer, Vancouver Centre, University of British Columbia, Vancouver, BC, Canada
  8. 8START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Hospital Universitario HM Sanchinarro, Madrid, Spain
  9. 9Department of Medical Oncology, Catalan Institute of Oncology (ICO) Girona, Girona Biomedical Research Institute (IDIBGI), Department of Medical Sciences, Medical School University of Girona (UdG), Girona, Spain
  10. 10Department of Chemotherapy, Regional Center of Oncology, Gdansk, Poland
  11. 11Gynecologic Oncology Group (GOG) and Department of Obstetrics/Gynecology, Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY
  12. 12Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Denmark, Nordic Society of Gynaecologic Oncology-Clinical Trial Unit, Copenhagen, Denmark
  13. 13Nemocnice Horovice, Horovice, Czech Republic
  14. 14GSK, Pennington, NJ
  15. 15GSK, Waltham, MA
  16. 16GSK, London, UK
  17. 17Gynaecology Unit, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK

Abstract

Introduction/Background Dostarlimab is an approved programmed death 1 (PD-1) inhibitor. PD-1 therapy can lead to immune-related adverse events (irAEs). Here we report on the management of irAEs across multiple tumour types evaluated in GARNET.

Methodology GARNET is a multicentre, open-label, single-arm phase 1 study with dose expansion in multiple tumour types: mismatch repair deficient solid tumours, mismatch repair proficient endometrial cancer, non-small cell lung cancer, and platinum-resistant ovarian cancer. Patients received 500 mg of dostarlimab intravenously Q3W for 4 cycles, then 1000 mg Q6W until disease progression, discontinuation, or withdrawal.

Results At this third interim analysis of GARNET, the safety population included 605 patients. irAEs were experienced by 32.2%, with 10.1% of patients experiencing grade ≥3 irAEs (table 1). Few, 5.5%, discontinued treatment because of an irAE. No irAEs led to death. Of patients experiencing irAEs, 64.6% were treated with immune modulatory medications (IMMs; referring to steroids, immune suppressant, and/or thyroid therapy); 58.7% of these patients experienced resolution. Average time to resolution was 69 days. For the 35.4% of patients not treated with IMMs, 56.5% experienced a resolution. Average time to resolution was 67 days. The most common irAEs were hypothyroidism (7.6%; 45 of 46 [97.8%] patients treated with thyroid therapy) and arthralgia (5.6%; 8 of 34 [23.5%] patients treated with steroids).

View this table:
Abstract 2022-RA-1144-ESGO Table 1

Conclusion Across all tumour types evaluated in GARNET, 32.2% of patients experienced irAEs, 68.7% of whom experienced grade 2 events. 58.7% of patients experienced resolution of irAEs upon treatment with an IMM. Overall discontinuation due to irAEs was low.

https://doi.org/10.1136/ijgc-2022-ESGO.437

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