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    DRUG:

    nemvaleukin alfa (ALKS 4230)

    i
    Other names: ALKS 4230, RDB 1419, ALKS-4230, RDB 1450, RDB-1419, RDB1419, ALKS4230, RDB1450, RDB-1450
    Company:
    Mural Oncology
    Drug class:
    IL-2R agonist
    Related drugs:
    3ms
    Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (clinicaltrials.gov)
    P3, N=456, Terminated, Mural Oncology, Inc | Trial completion date: May 2027 --> May 2025 | Active, not recruiting --> Terminated | Trial primary completion date: May 2026 --> Jan 2025; Study terminated due to business and strategic decision.
    Trial completion date • Trial termination • Trial primary completion date • Platinum resistant
    |
    Keytruda (pembrolizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • nemvaleukin alfa (ALKS 4230)
    4ms
    Nemvaleukin alfa monotherapy in patients with advanced melanoma and renal cell carcinoma: results from the phase 1/2 non-randomized ARTISTRY-1 trial. (PubMed, J Immunother Cancer)
    Nemvaleukin demonstrated pharmacodynamic proof of mechanism, with single-agent antitumor activity and manageable safety in patients with advanced melanoma and RCC.
    P1/2 data • Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Keytruda (pembrolizumab) • nemvaleukin alfa (ALKS 4230)
    6ms
    Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous or Mucosal Melanoma - ARTISTRY-6 (clinicaltrials.gov)
    P2, N=173, Terminated, Mural Oncology, Inc | Trial completion date: Sep 2026 --> May 2025 | Recruiting --> Terminated; Study terminated due to business and strategic decision.
    Trial completion date • Trial termination
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Keytruda (pembrolizumab) • nemvaleukin alfa (ALKS 4230)
    1year
    Nemvaleukin alfa, a modified interleukin-2 cytokine, as monotherapy and with pembrolizumab in patients with advanced solid tumors (ARTISTRY-1). (PubMed, J Immunother Cancer)
    Nemvaleukin was well tolerated and demonstrated promising antitumor activity across heavily pretreated advanced solid tumors. Phase 2/3 studies of nemvaleukin are ongoing.
    Journal • Metastases
    |
    CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • nemvaleukin alfa (ALKS 4230)
    over1year
    Novel engineered IL-2 Nemvaleukin alfa combined with PD1 checkpoint blockade enhances the systemic anti-tumor responses of radiation therapy. (PubMed, J Exp Clin Cancer Res)
    The addition of Nemvaleukin therapy may enhance responses to RT alone and in combination with anti-PD1.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker • Checkpoint block
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • CSF2 (Colony stimulating factor 2)
    |
    nemvaleukin alfa (ALKS 4230)
    over1year
    Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous or Mucosal Melanoma - ARTISTRY-6 (clinicaltrials.gov)
    P2, N=180, Recruiting, Mural Oncology, Inc | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Mar 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • nemvaleukin alfa (ALKS 4230)
    over1year
    Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (clinicaltrials.gov)
    P3, N=456, Active, not recruiting, Mural Oncology, Inc | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Keytruda (pembrolizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • nemvaleukin alfa (ALKS 4230)
    over1year
    Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3) (clinicaltrials.gov)
    P1/2, N=78, Active, not recruiting, Mural Oncology, Inc | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    MSI (Microsatellite instability) • NCAM1 (Neural cell adhesion molecule 1)
    |
    Keytruda (pembrolizumab) • nemvaleukin alfa (ALKS 4230)
    over1year
    Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (clinicaltrials.gov)
    P3, N=448, Recruiting, Mural Oncology, Inc | Active, not recruiting --> Recruiting | Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Dec 2025 --> May 2026
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy
    |
    Keytruda (pembrolizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • nemvaleukin alfa (ALKS 4230)
    over1year
    Autologous human preclinical modeling of melanoma interpatient clinical responses to immunotherapeutics. (PubMed, J Immunother Cancer)
    Our model reproduces differential effects of immunotherapy in melanoma patients, capturing the inherent heterogeneity in clinical responses. Taken together, these data demonstrate our model's translatability for novel immunotherapies in melanoma patients. The data are also supportive for the continued clinical investigation of nemvaleukin as a novel immunotherapeutic for the treatment of melanoma.
    Preclinical • Journal
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    nemvaleukin alfa (ALKS 4230)
    over1year
    Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (clinicaltrials.gov)
    P3, N=376, Active, not recruiting, Mural Oncology, Inc | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Keytruda (pembrolizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • nemvaleukin alfa (ALKS 4230)
    almost2years
    ARTISTRY-1: A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors (clinicaltrials.gov)
    P1/2, N=243, Completed, Mural Oncology, Inc | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nemvaleukin alfa (ALKS 4230)