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. 2023 Jul;19(23):1577-1591.
doi: 10.2217/fon-2023-0246. Epub 2023 Jun 19.

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

Thomas J Herzog  1 , John L Hays  2 , Joyce N Barlin  3 , Joseph Buscema  4 , Noelle G Cloven  5 , Lynn R Kong  6 , Nidhi Kumar Tyagi  7 , Grainger S Lanneau  8 , Beverly J Long  9 , Robert L Marsh  10 , Shelly M Seward  11 , David C Starks  12 , Stephen Welch  13 , Kathleen N Moore  14 , Panagiotis A Konstantinopoulos  15 , Lucy Gilbert  16 , Bradley J Monk  17 , David M O'Malley  2 , Xiwei Chen  18 , Rita Dalal  18 , Robert L Coleman  19 , Jalid Sehouli  20
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Free article

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

Thomas J Herzog et al. Future Oncol. 2023 Jul.
Free article

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).

Keywords: clinical trials; epithelial ovarian cancer; fallopian tube cancer; gynecologic/ovarian; immunotherapy; nemvaleukin alfa; pembrolizumab; phase III; platinum-resistant; primary peritoneal cancer.

Plain language summary

In many patients with ovarian cancer who are treated with platinum-based chemotherapy, the tumor comes back after a few months and fails to respond to repeated treatment. This type of disease is called platinum-resistant ovarian cancer (PROC). Researchers are searching for new medicines to help more patients with PROC. One treatment approach that has shown promise in different cancers is called immunotherapy. These medicines work by helping the body's immune system attack cancer cells. One of the immunotherapies being studied is called nemvaleukin. It is designed to trigger specific immune responses that may result in the immune system attacking cancer cells while potentially avoiding other immune responses that can block the attack or cause certain unwanted side effects. Nemvaleukin is being studied in a variety of cancer types. In a worldwide clinical trial called ARTISTRY-7, researchers are investigating how nemvaleukin works in patients with PROC when given with another immunotherapy called pembrolizumab. Patients who participate in this trial will be randomly assigned to one of four treatment groups: the combination of nemvaleukin and pembrolizumab, nemvaleukin by itself, pembrolizumab by itself, or a type of chemotherapy selected by the treating physician. The main purpose of ARTISTRY-7 is to understand whether the combination of nemvaleukin and pembrolizumab helps patients with PROC live longer without their cancer getting worse. At the time of this writing, ARTISTRY-7 is open for new patients to join.

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