Alkermes initiates ARTISTRY-7 phase III trial of nemvaleukin alfa in patients with platinum-resistant ovarian cancer.
Nemvaleukin, Alkermes' lead immuno-oncology candidate, is a novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy. As previously announced, ARTISTRY-7 is being conducted in collaboration with Merck Inc., which is providing Keytruda (pembrolizumab) for the study. In addition, Alkermes is working with The GOG Foundation, Inc. (GOG) and the European Network of Gynaecological Oncological Trial groups (ENGOT) to conduct the study. The FDA recently granted Fast Track designation to nemvaleukin in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer.
ARTISTRY-7 is a global phase III, open-label, randomized study designed to evaluate the anti-tumor activity and safety of IV nemvaleukin in combination with pembrolizumab compared to investigator's choice chemotherapy, with additional nemvaleukin and pembrolizumab monotherapy arms, in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The primary endpoint of ARTISTRY-7 is progression-free survival as assessed by the investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Additional endpoints include objective response rate, overall survival, disease control rate, duration of response, time to response, cancer antigen-125 response, pharmacokinetics (PK)/ pharmacodynamics (PD) and safety.
The study is expected to enroll approximately 376 patients. Patients will be randomized to one of four treatment arms to receive nemvaleukin and pembrolizumab combination therapy, pembrolizumab monotherapy, nemvaleukin monotherapy, or investigator's choice chemotherapy. More information can be found at www.clinicaltrials.gov (NCT05092360, GOG-3063, ENGOT-ov68).
About the ARTISTRY Clinical Development Program : ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.
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