– Trial-in-Progress Posters From ARTISTRY-6 and ARTISTRY-7 Clinical Trials to be Presented –
"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
Details of the poster presentations are as follows:
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,
Presentation Date: The poster will be presented on
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)
Presentation Date: The poster will be presented on
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
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.,
For Media: Sourojit Bhowmick, Ph.D., +1 781 609 6397
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