Mural Oncology Announces Publication Highlighting Promising Clinical Antitumor Activity Shown in its ARTISTRY-1 Clinical Trial of Nemvaleukin, its Lead Engineered Fusion Protein, in the Journal for ImmunoTherapy of Cancer
Mural Oncology has published promising clinical data from its completed ARTISTRY-1 phase 1/2 trial of nemvaleukin, showing positive antitumor activity in both monotherapy and combination therapy with pembrolizumab. The trial, involving 286 patients across 32 sites, demonstrated a 10% overall response rate in monotherapy and 13% in combination therapy. Notable results included a 21% response rate in platinum-resistant ovarian cancer (PROC) patients and 33.3% in mucosal melanoma patients. The treatment was generally well-tolerated with manageable side effects. Data readouts from two ongoing registrational trials are expected in Q1/Q2 2025.
Mural Oncology ha pubblicato dati clinici promettenti dal suo completato trial ARTISTRY-1 di fase 1/2 su nemvaleukin, mostrando una positiva attività antitumorale sia in monoterapia che in terapia combinata con pembrolizumab. Lo studio, che ha coinvolto 286 pazienti in 32 centri, ha dimostrato un tasso di risposta globale del 10% in monoterapia e del 13% in terapia combinata. Risultati notevoli hanno incluso un tasso di risposta del 21% nei pazienti con cancro ovarico resistente al platino (PROC) e del 33,3% nei pazienti con melanoma mucosale. Il trattamento è stato generalmente ben tollerato con effetti collaterali gestibili. I dati provenienti da due trial registrativi in corso sono attesi nel Q1/Q2 2025.
Mural Oncology ha publicado datos clínicos prometedores de su ensayo ARTISTRY-1 en fase 1/2 de nemvaleukin, mostrando una actividad antitumoral positiva tanto en monoterapia como en terapia combinada con pembrolizumab. El ensayo, que involucró a 286 pacientes en 32 sitios, demostró una tasa de respuesta global del 10% en monoterapia y del 13% en terapia combinada. Resultados notables incluyeron una tasa de respuesta del 21% en pacientes con cáncer de ovario resistente al platino (PROC) y del 33,3% en pacientes con melanoma mucosal. El tratamiento fue generalmente bien tolerado, con efectos secundarios manejables. Se esperan resultados de datos de dos ensayos registrativos en curso en el Q1/Q2 de 2025.
무랄 온콜로지는 넴발레우킨에 대한 완료된 ARTISTRY-1 1/2 단계 시험에서 유망한 임상 데이터를 발표하였으며, 모노 요법과 펨브롤리주맙과의 병용 요법 모두에서 긍정적인 항종양 활성을 보여주었습니다. 이 시험은 32개 사이트에서 286명의 환자가 참여했으며, 모노 요법에서 10%의 전체 반응률과 병용 요법에서 13%를 기록했습니다. 주목할 만한 결과로는 플래티넘 내성 난소암 (PROC) 환자에서 21%의 반응률, 점막 멜라노마 환자에서 33.3%의 반응률이 포함되었습니다. 치료는 일반적으로 잘 견디어졌으며 관리 가능한 부작용이 있었습니다. 두 개의 진행 중인 등록 시험의 데이터 출력은 2025년 1분기/2분기에 예상됩니다.
Mural Oncology a publié des données cliniques prometteuses de son essai ARTISTRY-1 de phase 1/2 sur nemvaleukin, montrant une activité antitumorale positive tant en monothérapie qu'en thérapie combinée avec pembrolizumab. L'essai, impliquant 286 patients répartis sur 32 sites, a démontré un taux de réponse global de 10 % en monothérapie et de 13 % en thérapie combinée. Résultats notables comprenaient un taux de réponse de 21 % chez les patients atteints de cancer de l'ovaire résistant au platine (PROC) et de 33,3 % chez les patients atteints de mélanome muqueux. Le traitement a généralement été bien toléré, avec des effets secondaires gérables. Les données de deux essais d'enregistrement en cours sont attendues pour le 1er ou 2e trimestre 2025.
Mural Oncology hat vielversprechende klinische Daten aus seiner abgeschlossenen ARTISTRY-1 Phase 1/2 Studie zu nemvaleukin veröffentlicht, die eine positive antitumorale Aktivität sowohl bei Monotherapie als auch bei Kombinationstherapie mit Pembrolizumab zeigt. Die Studie, an der 286 Patienten an 32 Standorten teilnahmen, zeigte eine allgemeine Ansprechrate von 10% in der Monotherapie und 13% in der Kombinationstherapie. Bemerkenswerte Ergebnisse umfassten eine Ansprechrate von 21% bei platinresistenten Eierstockkrebspatienten (PROC) und 33,3% bei Patienten mit mukosalem Melanom. Die Behandlung wurde im Allgemeinen gut vertragen, mit handhabbaren Nebenwirkungen. Daten aus zwei laufenden Registrierungsstudien werden im 1. und 2. Quartal 2025 erwartet.
- 10% overall response rate in monotherapy with confirmed partial responses
- 33.3% response rate in mucosal melanoma patients
- 13% overall response rate in combination therapy with pembrolizumab
- 21% response rate in platinum-resistant ovarian cancer patients
- Low discontinuation rate (4%) due to adverse events
- Treatment can be administered in outpatient setting
- Most common grade 3-4 treatment-related adverse events included neutropenia and anemia
Insights
The ARTISTRY-1 trial results demonstrate significant clinical progress for nemvaleukin, particularly in difficult-to-treat cancers. The 10% overall response rate in monotherapy and 13% ORR in combination therapy, while modest, are meaningful given the heavily pretreated patient population. The standout data points include a 33.3% ORR in mucosal melanoma and a remarkable 21% ORR in platinum-resistant ovarian cancer (PROC), including two complete responses.
The safety profile appears manageable with a low
For a company with a modest market cap of
The broad activity across multiple tumor types, including those resistant to existing immunotherapies, suggests potential for label expansion beyond initial indications. With pivotal trial readouts expected in early-to-mid 2025, successful results could drive substantial value creation. The manageable safety profile also supports potential combination strategies with other therapies, expanding market opportunities.
Nemvaleukin was generally well tolerated in ARTISTRY-1, a completed phase 1/2 clinical trial, with durable responses observed in both monotherapy and combination therapy across a range of heavily pretreated advanced solid tumors, including in platinum-resistant ovarian cancer (PROC), which does not typically respond to immunotherapies
Safety profile and anti-tumor activity observed in ARTISTRY-1 supported the company’s two potentially registrational trials, with readouts expected in late Q1/early Q2 2025 for PROC and Q2 2025 for mucosal melanoma
WALTHAM, Mass. and DUBLIN, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered therapies targeting cytokine pathways designed to address areas of unmet need for patients with a variety of cancers, today announced the publication of previously reported clinical data demonstrating tolerability and antitumor activity from ARTISTRY-1, a phase 1/2 trial of the company’s lead candidate, nemvaleukin alfa (nemvaleukin). The paper, titled “Nemvaleukin alfa as monotherapy and in combination with pembrolizumab in advanced solid tumors: the phase 1/2, non-randomized ARTISTRY-1 trial,” was published in the Journal for ImmunoTherapy of Cancer (JITC).
“While immunotherapies have marked a paradigm shift in the treatment of some types of cancers, many patients still face challenges, including lack of response, tolerability issues, or resistance to therapy, and there remains a great deal of unmet clinical need. In the ARTISTRY-1 study, notable antitumor activity of nemvaleukin was observed in both monotherapy and combination therapy. What was most striking were the durable and complete responses in platinum-resistant ovarian cancer, which does not usually respond to immunotherapy. These clinical data provide a solid foundation for Mural’s ongoing late-stage trials,” said Ulka Vaishampayan, MD, Professor, Internal Medicine, Division of Hematology/Oncology at the University of Michigan and the paper’s lead author.
Nemvaleukin is a novel, engineered fusion protein designed to leverage the antitumor effects of the IL-2 pathway while mitigating aldesleukin’s toxicity. ARTISTRY-1 was a three-part, open-label, phase 1/2 study evaluating the safety, tolerability, and efficacy of both nemvaleukin monotherapy and combination therapy with pembrolizumab. The study was conducted at 32 sites in seven countries, with 286 patients with advanced solid tumors enrolled and treated from July 2016 to March 2023.
ARTISTRY-1 is the foundation of Mural’s two ongoing potentially registrational trials, with data readouts expected in late Q1/early Q2 2025 for platinum-resistant ovarian cancer (PROC) and Q2 2025 for mucosal melanoma.
Key Findings:
As previously reported, nemvaleukin was generally well tolerated and demonstrated promising antitumor activity alone and in combination with pembrolizumab across heavily pretreated patients with advanced solid tumors. Robust expansion of CD8+ T cells and natural killer (NK) cells, with minimal expansion of regulatory T (Treg) cells were observed following treatment, thus supporting the design hypothesis of nemvaleukin.
Monotherapy:
10% overall response rate (ORR) with nemvaleukin monotherapy (7/68;95% CI 4 to 20), with all seven confirmed partial responses (melanoma, n=4; renal cell carcinoma, n=3).33.3% ORR in patients with mucosal melanoma, with two partial responses (one confirmed, one unconfirmed) in six evaluable patients. All responders had been on prior CPI therapy and progressed.
Combination therapy:
13% ORR with nemvaleukin and pembrolizumab (19/144;95% CI 8 to 20), with five confirmed complete responses and 14 confirmed partial responses. Six responses were in PD-(L)1 inhibitor-approved and five in PD-(L)1 inhibitor-unapproved tumor types.21% ORR in patients with PROC: Notably, there were three confirmed responses (two complete, one partial) in 14 evaluable patients with PROC, which does not normally respond to immunotherapy and for which there are no approved immunotherapies. Additionally, there was one unconfirmed partial response.- Durable, stable disease for greater than 6 months was observed in patients with cervical cancer, bladder cancer, non-small-cell lung cancer, PROC, and endometrial cancer.
Safety and Tolerability:
- Nemvaleukin was administered in an outpatient setting throughout treatment and had a manageable safety profile, with a low rate (
4% ) of discontinuation due to adverse events. - Most common grade 3-4 treatment-related adverse events (TREAs) were neutropenia and anemia.
About Mural Oncology
Mural Oncology is leveraging its novel protein engineering platform to develop cytokine-based immunotherapies for the treatment of cancer. By combining our expertise in cytokine biology and immune cell modulation and our protein engineering platform, we are developing medicines to deliver meaningful and clinical benefits to people living with cancer. Our mission is to broaden the potential, and reach, of cytokine-based immunotherapies to improve the lives of patients. Our lead candidate, nemvaleukin, is currently in potentially registrational trials in platinum-resistant ovarian cancer and mucosal melanoma reading out in the first half of 2025. Mural Oncology has its registered office in Dublin, Ireland, and its primary facilities in Waltham, Mass. For more information, visit Mural Oncology’s website at www.muraloncology.com and follow us on LinkedIn and X.
About Nemvaleukin
Nemvaleukin alfa (nemvaleukin) is an engineered fusion protein designed to leverage IL-2’s antitumor effects while mitigating the hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin is currently being evaluated in two potentially registrational late-stage trials.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the company’s pipeline and development programs, including the expected timing of clinical updates from the ARTISTRY-6 and ARTISTRY-7 trials, the potential of the company’s product candidates and programs to address unmet medical needs, and the continued progress of its pipeline and programs. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, the inherent risks and uncertainties associated with competitive developments, preclinical development, clinical trials, recruitment of patients, product development activities and regulatory approval requirements; that preclinical or interim results and data from ongoing clinical studies of the company’s cytokine programs and product candidates may not be predictive of future or final results from such studies, results of future clinical studies or real-world results; future clinical trials or future stages of ongoing clinical trials may not be initiated or completed on time or at all; the company’s product candidates, including nemvaleukin, could be shown to be unsafe or ineffective; changes in the cost, scope and duration of development activities; the U.S. Food and Drug Administration may make adverse decisions regarding the company’s product candidates; and those other risks and uncertainties set forth in the company’s filings with the Securities and Exchange Commission (“SEC”), including its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024 and in subsequent filings the company may make with the SEC. All forward-looking statements contained in this press release speak only as of the date of this press release. The company anticipates that subsequent events and developments will cause its views to change. However, the company undertakes no obligation to update such forward-looking statements to reflect events that occur or circumstances that exist after the date of this press release, except as required by law.
Contact:
Katie Sullivan
katie.sullivan@muraloncology.com
FAQ
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