"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
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,
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic value of nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230) as a monotherapy immunotherapy in patients with melanoma; the clinical trial design for ARTISTRY-6; and potential filing pathways for nemvaleukin in mucosal melanoma. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether nemvaleukin could be shown to be unsafe or ineffective; whether preclinical results and data from ongoing clinical studies for nemvaleukin will be predictive of future or final results from such studies, results of future clinical studies or real-world results; whether future clinical trials or future stages of ongoing clinical trials for nemvaleukin will be initiated or completed on time or at all; changes in the cost, scope and duration of, and clinical trial operations for, development activities for nemvaleukin, including changes relating to the impact of the novel coronavirus (COVID-19) pandemic; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
For Media: Sourojit Bhowmick, Ph.D. +1 781 609 6397
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