Alkermes Presents ARTISTRY-1 Data at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

– ARTISTRY-1 Data Showed Anti-Tumor Activity of Nemvaleukin, as a Monotherapy and in Combination with Pembrolizumab, in Multiple Tumor Types –

– Company to Host Investor Webcast on June 6 at 8:00 a.m. ET – 

DUBLIN, June 1, 2022 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans to present data from the ARTISTRY-1 clinical trial for nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy. The data will be presented in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 3-7, 2022 in Chicago and virtually, and in an investor webcast hosted by the company on June 6, 2022. 

The presentations will include efficacy and safety data from ARTISTRY-1, a phase 1/2 study evaluating the safety, tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with pembrolizumab (KEYTRUDA^®). In this study, nemvaleukin demonstrated anti-tumor activity with durable responses as monotherapy in checkpoint inhibitor (CPI)-experienced melanoma and renal cell carcinoma (RCC) patients and as combination therapy in pretreated patients across a range of difficult-to-treat tumors, including in tumor types where CPIs have had limited clinical benefit, and in CPI-experienced patients. Treatment-related adverse events (AEs) were mostly transient and manageable.

"The results of ARTISTRY-1 demonstrate that selectively targeting the IL-2 pathway may deliver significant clinical benefit in multiple tumor types while mitigating the hallmark toxicities associated with high-dose recombinant-IL-2," said Ulka N. Vaishampayan, M.D., Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan. "These data specifically highlight the potential clinical utility of nemvaleukin as a monotherapy and in combination with pembrolizumab in heavily pretreated patients across multiple tumor types, including in mucosal melanoma and platinum-resistant ovarian cancer."

"ARTISTRY-1 provided important data that has revealed nemvaleukin's pharmacokinetic and pharmacodynamic profile, exhibited similar monotherapy anti-tumor activity as seen with high-dose IL-2, demonstrated anti-tumor activity in combination with a CPI, and established a differentiated safety and tolerability profile," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "As we focus on enrolling our potential registrational studies, ARTISTRY-6 in mucosal melanoma and ARTISTRY-7 in platinum-resistant ovarian cancer, these data from ARTISTRY-1 further reinforce our understanding of nemvaleukin's profile and our belief in its clinical potential."

Data highlights from the ASCO oral presentation and the company's investor presentation include the following (all data are as of the Oct. 29, 2021 ASCO data cutoff date, unless otherwise noted):

ARTISTRY-1, Nemvaleukin IV Monotherapy

The ARTISTRY-1 monotherapy cohorts included heavily pretreated, CPI-experienced patients with advanced melanoma or RCC.

• Melanoma monotherapy cohort (46 evaluable patients):
• Six patients achieved a partial response (PR), of which three were confirmed. Two of the six PRs were reported after the ASCO data cutoff date.
• Stable disease (SD) was observed in 31 patients.
• All melanoma patients who achieved a PR with nemvaleukin monotherapy had previously progressed on CPI treatment.
• Out of six evaluable mucosal melanoma patients, two patients achieved a PR (one confirmed). One of these two patients who achieved a PR remained on nemvaleukin monotherapy for more than two years, with a duration of response (DOR) of 79 weeks.
• RCC monotherapy cohort (22 evaluable patients):
• Four patients achieved a PR, of which three were confirmed. Three of the patients who achieved a PR remained on nemvaleukin monotherapy for a range of 24 – 63 weeks.
• SD was observed in 10 patients.
• All RCC patients who achieved a PR with nemvaleukin monotherapy had previously progressed on CPI treatment.

ARTISTRY-1, Nemvaleukin IV in Combination With Pembrolizumab
The ARTISTRY-1 combination cohorts included patients with PD-1/L1 unapproved tumor types; patients with PD-1/L1 approved tumor types (PD-1/L1 pretreated and PD-1/L1 treatment naïve) as well as tumor-specific cohorts and a cohort for patients who rolled over into a combination cohort from a monotherapy cohort.

Among the 137 total evaluable patients, four complete responses (CRs) and 18 PRs were observed, SD was observed in 60 patients, and overall median DOR was 23 weeks.

• In the PD-1/L1 unapproved cohort (36 evaluable patients):
• Two patients achieved a CR, four patients achieved a PR and SD was observed in 14 patients.
• Both of these CRs and two of these PRs (one confirmed), were in patients with platinum-resistant ovarian cancer (PROC) (out of 14 evaluable PROC patients in this cohort). Median DOR in the PROC cohort was 53 weeks.
• In the PD-1/L1 approved cohorts (total 43 evaluable patients):
• Among 22 evaluable pretreated patients, one patient achieved a PR and SD was observed in 10 patients.
• Among 21 evaluable PD-1/L1 naïve patients, one patient achieved a CR, six patients achieved PRs and SD was observed in seven patients.

Treatment-related adverse events (TRAEs) across the ARTISTRY-1 study were consistent with those previously reported for the IV nemvaleukin monotherapy and combination therapy-treated populations from the trial. Pyrexia, chills and neutropenia/decreased neutrophil count were the most commonly reported TRAEs. Across the ARTISTRY-1 study, nemvaleukin in combination with pembrolizumab demonstrated no additive toxicity compared to pembrolizumab alone and no event of capillary leak syndrome was reported.

"Immunotherapies have revolutionized cancer treatment, but significant unmet need remains, as many patients are not eligible or do not respond to certain immunotherapies such as checkpoint inhibitors. Broadening the benefits of immunotherapy to a wider range of patients is an important goal for the treatment community and cancer researchers," said Jill O'Donnell-Tormey, Ph.D., Chief Executive Officer and Director of Scientific Affairs, Cancer Research Institute. "These data from ARTISTRY-1, particularly in patients who are not eligible for current immunotherapies such as a PD-1/L1 inhibitor or who have progressed following treatment with immunotherapies, suggest that nemvaleukin may provide clinical benefit in this patient population. These data support further evaluation of nemvaleukin in future studies."

Trial-in-progress posters from the ongoing ARTISTRY-3 trial and the potential registration-enabling ARTISTRY-6 and ARTISTRY-7 trials will also be presented at the ASCO meeting.

All presentations are available on the ASCO website at https://meetinglibrary.asco.org/.

Oral Presentation
Abstract: 2500
Title: Nemvaleukin alfa monotherapy and in combination with pembrolizumab in patients (pts) with advanced solid tumors: ARTISTRY-1 
Presenter: Ulka N. Vaishampayan, M.D., Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan
Presentation Date/Time: The oral presentation will take place on Saturday, June 4, 2022 from 1:15 – 4:15 p.m. CDT, during the session titled "Developmental Therapeutics—Immunotherapy"

Poster Presentations
Abstract: TPS5609
Title: ARTISTRY-7: A phase 3, multicenter study of nemvaleukin alfa in combination with pembrolizumab versus chemotherapy in patients (pts) with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
Presenter: Thomas J. Herzog, M.D., Professor of Obstetrics and Gynecology, Deputy Director, University of Cincinnati Cancer Institute and Associate Director of GOG Partners
Presentation Session Date/Time: The poster will be presented on Saturday, June 4, 2022 from 1:15 – 4:15 p.m. CDT, during the "Gynecologic Cancers" poster session

Abstract: TPS2684
Title: ARTISTRY-3: Effect of nemvaleukin alfa with a less frequent IV dosing schedule as monotherapy and in combination with pembrolizumab and impact on the tumor microenvironment (TME) in patients (pts) with advanced solid tumors
Presenter: Sarina A. Piha-Paul, M.D., Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center
Presentation Session Date/Time: The poster will be presented on Sunday, June 5, 2022 from 8:00 – 11:00 a.m. CDT, during the "Developmental Therapeutics—Immunotherapy" poster session

Abstract: TPS9609
Title: ARTISTRY-6: Nemvaleukin alfa monotherapy in patients with advanced mucosal and cutaneous melanoma
Presenter: Jeffrey S. Weber, M.D., Ph.D., Professor of Medicine, Deputy Director, Laura and Isaac Perlmutter Cancer Center, New York University School of Medicine
Presentation Session Date/Time: The poster will be presented on Monday, June 6, 2022 from 1:15 – 4:15 p.m. CDT, during the "Melanoma/Skin Cancers" poster session

Conference Call and Webcast
Alkermes will host a webcast presentation and conference call with accompanying slides for analysts and investors on Monday, June 6, 2022, at 8:00 a.m. ET (1:00 p.m. BST) to discuss data from the ARTISTRY-1 clinical trial and the ARTISTRY clinical program. The webcast will feature ARTISTRY clinical program investigators, Ulka N. Vaishampayan, M.D., Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan; Omid Hamid, M.D., Co-director of Cutaneous Oncology, Director of Melanoma Therapeutics and Phase I Immuno-oncology Program, Chief of Translational Research and Immunotherapy, The Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles; Thomas J. Herzog, M.D., Professor of Obstetrics and Gynecology, Deputy Director University of Cincinnati Cancer Institute, Associate Director of GOG Partners; and members of Alkermes' management team. The webcast player may be accessed on the Investors section of Alkermes' website at www.alkermes.com. To participate in the question-and-answer session, please also dial in to the conference call, which may be accessed by dialing +1 877-407-2988 for U.S. callers and +1 201-389-0923 for international callers. A replay of the webcast will be archived on the company's website for 30 days following the presentation.

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. 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 neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has a Research & 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 potential clinical value and utility of nemvaleukin as an immunotherapy, whether as monotherapy or in combination, in multiple 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; 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, 2021, 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

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