ARTISTRY-7: phase III trial of nemvaleukin alfa plus pembrolizumab vs chemotherapy for platinum-resistant ovarian cancer

Author:

Herzog Thomas J1ORCID,Hays John L2,Barlin Joyce N3,Buscema Joseph4,Cloven Noelle G5,Kong Lynn R6ORCID,Tyagi Nidhi Kumar7,Lanneau Grainger S8,Long Beverly J9,Marsh Robert L10,Seward Shelly M11,Starks David C12,Welch Stephen13,Moore Kathleen N14ORCID,Konstantinopoulos Panagiotis A15,Gilbert Lucy16,Monk Bradley J17,O'Malley David M2,Chen Xiwei18,Dalal Rita18,Coleman Robert L19,Sehouli Jalid20

Affiliation:

1. University of Cincinnati Cancer Center, UC College of Medicine, Cincinnati, OH 45267, USA

2. Wexner Medical Center & James Cancer Hospital, Ohio State University, Columbus, OH 43210, USA

3. Women's Cancer Care Associates, Albany, NY 12208, USA

4. Arizona Oncology Associates, PC, Tucson, AZ 85718, USA

5. Texas Oncology – Fort Worth Cancer Center, Fort Worth, TX 76104, USA

6. Ventura County Hematology Oncology Specialists, Oxnard, CA 93930, USA

7. Hamilton Health Sciences, Hamilton, ON, L8N 3Z5, Canada

8. ECU Health, Greenville, NC 27834, USA

9. Sarasota Memorial Healthcare System, Sarasota, FL 34239, USA

10. Virginia Cancer Specialists, Gainesville, VA 20155, USA

11. Orlando Health, Inc., Orlando, FL 32806, USA

12. Avera Cancer Institute, Sioux Falls, SD 57105, USA

13. London Health Sciences Centre, London, ON, N6A 5A5, Canada

14. College of Medicine, University of Oklahoma, Oklahoma City, OK 73117, USA

15. Dana-Farber Cancer Institute, Boston, MA 02215, USA

16. McGill University Health Centre, Women's Health Research Unit, Montréal, QC, H3H 2R9, Canada

17. HonorHealth Research Institute, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ 85012, USA

18. Alkermes, Inc., Waltham, MA 02451, USA

19. US Oncology Research, The Woodlands, TX 77380, USA

20. Charité Universitaetsmedizin Berlin Charité Campus Virchow-Klinikum, Berlin, 11017, Germany

Abstract

Standard single-agent nonplatinum chemotherapy provides only modest benefit in a small proportion of patients with platinum-resistant/-refractory ovarian cancer, with objective response rates of 6–20% and progression-free survival of ≈3–4 months. Nemvaleukin alfa (nemvaleukin, ALKS 4230) is a novel cytokine designed to capture and expand the therapeutic potential of high-dose interleukin-2 (IL-2) while mitigating its associated toxicity issues. Nemvaleukin preferentially activates cytotoxic CD8+ T cells and natural killer cells with minimal, non-dose-dependent effects on CD4+ regulatory T cells. The global, randomized, open-label, phase III ARTISTRY-7 trial will compare efficacy and safety of nemvaleukin plus pembrolizumab with chemotherapy in patients with platinum-resistant ovarian cancer. The primary end point is investigator-assessed progression-free survival. Clinical Trial Registration: GOG-3063; ENGOT-OV68; NCT05092360 ( ClinicalTrials.gov )

Funder

Alkermes, Inc.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

Reference55 articles.

1. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

2. Cancer statistics, 2022

3. Immunotherapy in the Treatment of Platinum-Resistant Ovarian Cancer: Current Perspectives

4. Updated treatment recommendations for newly diagnosed epithelial ovarian carcinoma from the ESMO Clinical Practice Guidelines

5. National Comprehensive Cancer Network. Clinical practice guidelines in oncology. Ovarian cancer, fallopian tube cancer, and primary peritoneal cancer V.1.2023 (2022). https://www.nccn.org/professionals/physician_gls/pdf/ovarian_blocks.pdf

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