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Alkermes Initiates ARTISTRY-7 Phase 3 Trial of Nemvaleukin Alfa in Patients With Platinum-Resistant Ovarian Cancer
- Study to Evaluate Intravenous Nemvaleukin in Combination With Pembrolizumab Compared to Investigator's Choice Chemotherapy - DUBLIN, Oct. 26, 2021
About this update from Alkermes Plc
[{"type":"text","content":"- Study to Evaluate Intravenous Nemvaleukin in Combination With Pembrolizumab Compared to Investigator's Choice Chemotherapy -\n\n\nDUBLIN, Oct. 26, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the initiation of ARTISTRY-7, a global phase 3, open-label, randomized trial evaluating the anti-tumor activity and safety of intravenously administered (IV) nemvaleukin alfa (nemvaleukin), in combination with pembrolizumab, compared to investigator's choice chemotherapy, 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 MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA), 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 U.S. Food and Drug Administration recently granted Fast Track designation to nemvaleukin in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer.\n\"The initiation of our phase 3 study of nemvaleukin in platinum-resistant ovarian cancer is an important milestone for the nemvaleukin clinical development program and reflects our commitment to focusing on the high unmet need of patients living with difficult-to-treat cancers such as platinum-resistant ovarian cancer,\" said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. \"ARTISTRY-7 is designed to build upon the durable and deepening responses observed in heavily pre-treated patients with platinum-resistant ovarian cancer in the ongoing ARTISTRY-1 study. We look forward to sharing updates from ARTISTRY-7 as the study progresses and as we advance toward potential registration.\"\nARTISTRY-7 is a global phase 3, 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 p...