Alkermes Initiates ARTISTRY-6 Trial of Nemvaleukin Alfa Monotherapy in Patients With Melanoma

DUBLIN, Ireland I April 27, 2021 IAlkermes plc (Nasdaq: ALKS) today announced the initiation of ARTISTRY-6, a global phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin alfa (nemvaleukin) monotherapy in patients with melanoma who have been previously treated with anti-PD-(L)1 therapy. The study will evaluate intravenously administered (IV) nemvaleukin in patients with mucosal melanoma and subcutaneously administered (SC) nemvaleukin in patients with advanced cutaneous melanoma. Nemvaleukin, Alkermes' lead immuno-oncology candidate, is a novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy. Nemvaleukin was granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food and Drug Administration (FDA) in March 2021.

"The initiation of the ARTISTRY-6 study represents a significant milestone in the nemvaleukin development program, building on the early signals of anti-tumor activity observed with IV nemvaleukin in melanoma," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President at Alkermes. "Consistent with our strategy to study nemvaleukin in difficult-to-treat cancers with clear unmet need, we look forward to further evaluating the potential clinical utility of nemvaleukin monotherapy in mucosal melanoma, a rare and aggressive form of melanoma that has very limited treatment options. We recently discussed with the FDA a potential filing pathway in mucosal melanoma, pending review of data that emerge from ARTISTRY-6."

ARTISTRY-6 is designed to evaluate the anti-tumor activity, safety and tolerability of IV nemvaleukin in patients with mucosal melanoma. The study also includes a cohort of patients with advanced cutaneous melanoma who will receive SC nemvaleukin with intent to establish monotherapy proof-of -concept with SC dosing. The primary endpoint of ARTISTRY-6 is centrally-assessed overall response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, to be evaluated separately for patients with mucosal or cutaneous melanoma. The secondary endpoints include safety and tolerability, duration of response, progression-free survival, disease control rate and time to response based on RECIST 1.1. Additionally, the phase 2 study will assess health-related quality of life, and pharmacokinetic and pharmacodynamic effects of IV and SC nemvaleukin monotherapy. The study is planned to enroll approximately 110 patients. Patients will be enrolled into one of two cohorts: patients with advanced mucosal melanoma will receive 6 µg/kg/day IV nemvaleukin for 5 consecutive days every 3 weeks, and patients with advanced cutaneous melanoma will receive 3 mg SC nemvaleukin once every 7 days.

More information can be found at www.clinicaltrials.gov, identifier: NCT04830124.

About Nemvaleukin alfa ("nemvaleukin", formerly ALKS 4230)
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 selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially 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 alfa 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 include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.

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 and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, 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.

SOURCE: Alkermes

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