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#487 ARTISTRY-7: a phase 3, multicenter study of nemvaleukin alfa in combination with pembrolizumab versus chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (GOG-3063; ENGOT-OV68)
  1. Jalid Sehouli1,
  2. John L Hays2,
  3. Joyce N Barlin3,
  4. Joseph Buscema4,
  5. Noelle G Cloven5,
  6. Lynn R Kong6,
  7. Nidhi Kumar Tyagi7,
  8. Grainger S Lanneau8,
  9. Beverly J Long9,
  10. Robert L Marsh10,
  11. Shelly M Seward11,
  12. David C Starks12,
  13. Stephen Welch13,
  14. Kathleen N Moore14,
  15. Panagiotis A Konstantinopoulos15,
  16. Lucy Gilbert16,
  17. Bradley J Monk17,
  18. David M O’Malley18,
  19. Robert L Coleman19 and
  20. Thomas J Herzog20
  1. 1Charité Universitaetsmedizin Berlin Charité Campus Virchow-Klinikum, Berlin, Germany
  2. 2Wexner Medical Center and James Cancer Hospital, Ohio State University, Columbus, Oh, United States
  3. 3Women’s Cancer Care Associates, Albany, Ny, United States
  4. 4Arizona Oncology Associates PC, Tucson, Az, United States
  5. 5Texas Oncology-Fort Worth Cancer Center, Fort Worth, Tx, United States
  6. 6Ventura County Hematology Oncology Specialists, Oxnard, Ca, United States
  7. 7Hamilton Health Sciences, Hamilton, On, Canada
  8. 8ECU Health, Greenville, Nc, United States
  9. 9Sarasota Memorial Healthcare System, Sarasota, Fl, United States
  10. 10Virginia Cancer Specialists, Gainsville, Va, United States
  11. 11Orlando Health, Inc., Orlando, Fl, United States
  12. 12Avera Cancer Institute, Sioux Falls, Sd, United States
  13. 13London Health Sciences Centre, London, On, United States
  14. 14College of Medicine, University of Oklahoma, Oklahoma City, Ok, United States
  15. 15Dana-Farber Cancer Institute, Boston, Ma, United States
  16. 16McGill University Health Centre, Woman’s Health Research Unit, Montréal, Qc, Canada
  17. 17HonorHealth Research Institute, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, Az, United States
  18. 18The Ohio State University And James Comprehensive Cancer Center, Columbus, Oh, United States
  19. 19Texas Oncology, The Woodlands, Tx, United States
  20. 20College of Medicine, University of Cincinnati, Cincinnati, Oh, United States


Introduction/Background ARTISTRY-7 will evaluate the novel engineered cytokine nemvaleukin alfa (nemvaleukin) in gynaecologic cancers. Nemvaleukin was designed to selectively bind to the intermediate-affinity interleukin-2 (IL-2) receptor, preferentially activating antitumour CD8+ T and NK cells with minimal regulatory T cell expansion, which may provide enhanced tumour killing and improved safety/tolerability versus high-dose IL-2. In preclinical studies, addition of a mouse nemvaleukin ortholog to anti-PD-1 treatment slowed tumour growth and increased survival in the EMT6 mouse tumour model. In ARTISTRY-1, responses were observed with nemvaleukin+pembrolizumab in 4 patients with platinum-resistant ovarian cancer (OC): 2 complete responses (1 in a patient with 5 prior lines of therapy), and 2 partial responses.

Methodology ARTISTRY-7 (NCT05092360) is an ongoing phase 3, multicentre, randomised study of nemvaleukin and/or pembrolizumab versus chemotherapy that is currently enrolling. Eligible patients are women (≥18 years) with histologically confirmed epithelial ovarian (high-grade serous, endometrioid, clear cell), fallopian tube, or primary peritoneal cancer. Patients must have had ≥1 prior line of platinum-based therapy, ≤5 prior lines of systemic anticancer therapy (platinum-resistant setting), and prior bevacizumab, with radiographic progression on most recent therapy. Patients with primary platinum-refractory disease (progression on first-line platinum therapy) or primary platinum resistance (progression <3 months after first-line platinum therapy completion) are excluded.

Approximately 376 patients will be randomised (3:1:1:3) to receive nemvaleukin 6 μg/kg IV (days 1–5)+pembrolizumab 200 mg IV (day 1) of each 21-day cycle, pembrolizumab or nemvaleukin monotherapy, or chemotherapy, and stratified by PD-L1 status, histologic subtype, and chemotherapy (paclitaxel vs others). Patients will continue treatment until disease progression or intolerable toxicity (maximum 35 pembrolizumab cycles; nemvaleukin can be continued). Primary endpoint: investigator-assessed progression-free survival (RECIST v1.1) with nemvaleukin+pembrolizumab vs chemotherapy. Secondary/exploratory endpoints include overall survival, other antitumor measures, safety, health-related quality of life, and pharmacokinetic/pharmacodynamic effects.

Results Trial in progress

Conclusion Pending data availability

Disclosures This study is funded by Alkermes, Inc. Medical writing and editorial support was provided by Parexel International, and funded by Alkermes, Inc.

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