• Trial-in-Progress Posters From ARTISTRY-6 and ARTISTRY-7 Clinical Trials to be Presented

DUBLIN, May 9, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the acceptance of two abstracts related to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago June 2-6, 2023. Trial-in-progress posters from the actively recruiting phase 2 ARTISTRY-6 clinical trial and phase 3 ARTISTRY-7 clinical trial will be presented. ARTISTRY-6 is evaluating nemvaleukin as a monotherapy in patients with advanced cutaneous melanoma or advanced mucosal melanoma. ARTISTRY-7 is evaluating nemvaleukin as a monotherapy and in combination with pembrolizumab in comparison to investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.

"The 2023 ASCO Annual Meeting provides a timely opportunity to engage with clinical trial investigators and share important information related to nemvaleukin and our potential registration-enabling clinical trials, ARTISTRY-6 and ARTISTRY-7," said Jessicca Rege, Vice President, Clinical Research, Oncology. "Enrollment in both ARTISTRY-6 and ARTISTRY-7 is underway and we are excited to continue to accumulate data from these studies which we believe have potential to support registration in two difficult-to-treat tumor types."

Details of the poster presentations are as follows:

Abstract: TPS9592

Title: ARTISTRY-6: nemvaleukin alfa monotherapy in patients with advanced mucosal and cutaneous melanoma
Presenter: Jeffrey S. Weber, Ph.D., M.D., Professor of Medicine, NYU School of Medicine and Deputy Director, Laura and Isaac Perlmutter Cancer Center
Presentation Date: The poster will be presented on Saturday, June 3, 2023 from 1:15 – 4:15 p.m. CDT, during the "Melanoma/Skin Cancers" poster session

Abstract: TPS5612

Title: ARTISTRY-7: a phase 3, multicenter study of nemvaleukin alfa in combination with pembrolizumab versus chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (GOG-3063; ENGOT-OV68)
Presenter: Thomas J. Herzog, M.D., Professor of Obstetrics and Gynecology, Deputy Director, University of Cincinnati Cancer Institute
Presentation Date: The poster will be presented on Monday, June 5, 2023 from 1:15 – 4:15 p.m. CDT, during the "Gynecologic Cancer" poster session

For more information on our currently enrolling, potential registration-enabling clinical trials, visit the ARTISTRY-6 and ARTISTRY-7 websites.

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. Nemvaleukin is currently the most advanced IL-2-based immunotherapy in clinical development, with two actively recruiting, potentially registrational studies, ARTISTRY-6 and ARTISTRY-7 in mucosal melanoma and platinum-resistant ovarian cancer, respectively.

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. Trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-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 alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurological disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has a research and development 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.

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 therapeutic and commercial potential of nemvaleukin as an immunotherapy, including for mucosal melanoma and platinum-resistant ovarian cancer, and the company's expectations concerning the ability of data from ARTISTRY-6 and ARTISTRY-7 to support registration in difficult-to-treat tumor types. 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 results and data from 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; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may not agree with the company's regulatory approval strategies or components of the company's marketing applications and their sufficiency to support potential approval; 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 Dec. 31, 2022, and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Alkermes Contacts:
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Sourojit Bhowmick, Ph.D., +1 781 609 6397