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, Ireland I October 26, 2021 I 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.

"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."

ARTISTRY-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 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 Nemvaleukin Alfa (nemvaleukin)
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

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-1ARTISTRY-2ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.

About Alkermes plc
Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

About The GOG Foundation, Inc. (www.gog.org)
The GOG Foundation, Inc. (GOG) is a not-for profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials, development, execution, analysis and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancers of the ovaries, uterus, cervix, vagina, and vulva.

The GOG Partners, a GOG Foundation program, is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners shares the same mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network.

About ENGOT
ENGOT (European Network for Gynaecological Oncological Trial groups) is a research network of the European Society of Gynecological Oncology (ESGO) and was founded in 2007. ENGOT is a platform that guarantees that the European spirit and culture is incorporated into the medical progress in gynaecological oncology, and that European patients and countries can participate in an active way in clinical research and progress. Currently, ENGOT includes 21 cooperative groups from 25 European countries.

SOURCE: Alkermes

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