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2022-RA-588-ESGO Nemvaleukin alfa monotherapy and in combination with pembrolizumab in patients with advanced solid tumours: ARTISTRY-1
  1. Ulka Vaishampayan1,
  2. Piotr Tomczak2,
  3. Jameel Muzaffar3,
  4. Ira Winer4,
  5. Seth D Rosen5,
  6. Christopher J Hoimes6,7,
  7. Aman Chauhan8,
  8. Anna Spreafico9,
  9. Karl D Lewis10,
  10. Debora S Bruno11,
  11. Olivier Dumas12,
  12. David F McDermott13,
  13. James F Strauss14,
  14. Quincy Siu-Chung Chu15,
  15. Lucy Gilbert16,
  16. Arvind Chaudhry17,
  17. Jessicca Rege18,
  18. Valentina Boni19,
  19. Marc S Ernstoff20 and
  20. Vamsidhar Velcheti21
  1. 1University of Michigan Rogel Cancer Center, Ann Arbor, MI
  2. 2Klinika Onkologii Oddzial Chemioterapii, Poznan, Poland
  3. 3Moffitt Cancer Center, Tampa, FL
  4. 4Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI
  5. 5Hematology Oncology Association of the Treasure Coast, Port St. Lucie, FL
  6. 6Duke University Medical Center, Durham, NC
  7. 7University Hospitals, Phase I Oncology Program, Case Comprehensive Cancer Center, Cleveland, OH
  8. 8University of Kentucky, Lexington, KY
  9. 9Princess Margaret Cancer Centre, Toronto, ON, Canada
  10. 10University of Colorado School of Medicine, Aurora, CO
  11. 11University Hospitals, Thoracic Oncology Program, Case Comprehensive Cancer Center, Cleveland, OH
  12. 12CHU de Québec-Université Laval, Québec City, QC, Canada
  13. 13Beth Israel Deaconess Medical Center, Boston, MD
  14. 14Mary Crowley Cancer Research, Dallas, TX
  15. 1514Cross Cancer Institute, University of Alberta/Alberta Health Services, Edmonton, AB, Canada
  16. 16Division of Gynecologic Oncology, McGill University Health Centre, Montreal, QC, Canada
  17. 17Summit Cancer Centers, Spokane, WA
  18. 18Alkermes, Inc., Waltham, MA
  19. 19NEXT Oncology Madridc, Hospital Universitario, Quironsalud, Spain
  20. 20Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY
  21. 21Laura and Isaac Perlmutter Cancer Center, New York University, New York, NY


Introduction/Background Nemvaleukin alfa (nemvaleukin, ALKS 4230) is an engineered cytokine that selectively binds to the intermediate-affinity interleukin-2 (IL-2) receptor to preferentially activate anti-tumour CD8+ T and natural killer cells with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin was designed to leverage anti-tumour effects of the IL-2 pathway while mitigating toxicities associated with activation of the high-affinity IL-2 receptor.

Methodology ARTISTRY-1 (NCT02799095) is a 3-part, first-in-human, phase 1/2 study of intravenous nemvaleukin +/- pembrolizumab in patients with advanced solid tumours. Parts A (monotherapy dose escalation to 10 µg/kg/day ×5/cycle), B (monotherapy in patients with melanoma or renal cell carcinoma [RCC]), and C (combination with nemvaleukin 3 or 6 µg/kg/day ×5/cycle and pembrolizumab every 21 days) were included. Investigator-assessed anti-tumour activity (RECIST v1.1) and safety are reported as of 29 October 2021.

Results In Part A (N=46), nemvaleukin recommended phase 2 dose was 6 µg/kg/day intravenously ×5/cycle. The maximum tolerated dose was not reached. Nemvaleukin monotherapy demonstrated durable anti-tumour activity in RCC (objective response rate [ORR], 18.2% [4/22]) and melanoma (ORR, 8.7% [4/46]), with 2 partial responses (PRs; 1 unconfirmed) in 30 patients with cutaneous melanoma (ORR, 6.7%) and 2 PRs (1 unconfirmed) in 6 patients with mucosal melanoma (ORR, 33.3%). Durable anti-tumour activity was also observed for combination therapy (ORR, 16.1% [22/137]; disease control rate [DCR], 59.9%), including in platinum-resistant ovarian cancer, with 2 complete responses and 2 PRs (1 unconfirmed) in 14 patients (ORR, 28.6% [4/14]; DCR, 71.4%). 43 patients remain on therapy. Most common grade 3/4 treatment-related adverse events in Parts B and C, respectively, were anaemia (9%, 10%), neutropaenia (34%, 9%), and decreased neutrophil count (12%, 9%).

Conclusion Nemvaleukin was generally well tolerated.

Durable responses were observed with monotherapy and combination therapy in heavily pre-treated patients across a range of tumours, warranting further investigation.

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