nemvaleukin alfa (ALKS 4230) / Mural Oncology 
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  • ||||||||||  nemvaleukin alfa (ALKS 4230) / Alkermes
    Pattern of natural killer (NK) cell (CD16+CD56+) expansion correlates with response outcomes with nemvaleukin alfa treatment (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1071;    
    14 also demonstrated a significant difference in PFS for the combination cohorts as shown in figures 2 (Group 2) and figures 3 (Group 3). Conclusions This exploratory analysis establishes the foundation for NK cell expansion as a novel predictive biomarker of response to nemvaleukin in melanoma and other solid tumors and warrants further prospective validation in larger ongoing studies.
  • ||||||||||  Proleukin (aldesleukin) / Novartis, Prometheus, Iovance Biotherap, nemvaleukin alfa (ALKS 4230) / Alkermes
    Review, Journal:  Rethinking Oncologic Treatment Strategies with Interleukin-2. (Pubmed Central) -  May 17, 2023   
    High-dose recombinant human IL-2 (rhIL-2, aldesleukin) emerged as an important treatment option for selected patients with metastatic melanoma and metastatic renal cell carcinoma, producing durable and long-lasting antitumor responses in a small fraction of patients and heralding the potential of cancer immunotherapy...In this review, we highlight novel drug development strategies, including biochemical modifications and engineered IL-2 variants, to expand the narrow therapeutic window of IL-2 by leveraging downstream activation of the IL-2 receptor to selectively expand anti-tumor CD8-positive T cells and natural killer cells. These modified IL-2 cytokines improve single-agent activity in solid tumor malignancies beyond the established United States Food and Drug Administration (FDA) indications of metastatic melanoma and renal cell carcinoma, and may also be safer in rational combinations with established treatment modalities, including anti-PD-(L)1 and anti-CTLA-4 immunotherapy, chemotherapies, and targeted therapy approaches.
  • ||||||||||  nemvaleukin alfa (ALKS 4230) / Alkermes, Keytruda (pembrolizumab) / Merck (MSD)
    A novel murine tumor model for assessing the efficacy of neoadjuvant dosing regimens for immunotherapies (Section 24; Poster Board #20) -  Mar 14, 2023 - Abstract #AACR2023AACR_3996;    
    Moreover, long-term immunity was 100% effective if the re-challenge experiment was performed out to 5 months after the last dose of mNemva had been administered.Therefore, the neoadjuvant/adjuvant dosing regimen exhibits a superior response in this preclinical model, when combined with partial tumor-debulking surgery, similar to the recent findings in patients with melanoma that were treated with pembrolizumab. In addition, this strategy enables sampling of tumor tissue for analyses of the immune response and the identification of potential predictive markers of response.
  • ||||||||||  nemvaleukin alfa (ALKS 4230) / Alkermes
    Developing an autologous humanized mouse model to assess responses to novel immunotherapeutics (Section 23; Poster Board #22) -  Mar 14, 2023 - Abstract #AACR2023AACR_3967;    
    In this all autologous humanized melanoma mouse model, nemvaleukin treatment not only enhances T cell engraftment, it significantly augments anti-tumor efficacy. These data support the use of this personalized melanoma xenograft model to analyze the underlying immune responses in responders and non-responders to novel immunotherapies.
  • ||||||||||  nemvaleukin alfa (ALKS 4230) / Mural Oncology
    Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  ARTISTRY-1: A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors (clinicaltrials.gov) -  Nov 25, 2022   
    P1/2,  N=243, Active, not recruiting, 
    Our findings support the evaluation of nemvaleukin alone or in combination with chemotherapy in clinical trials for the treatment of SCLC. Trial completion date: Jan 2023 --> Jul 2023 | Trial primary completion date: Jan 2023 --> Jul 2023
  • ||||||||||  nemvaleukin alfa (ALKS 4230) / Mural Oncology
    Trial completion, Trial completion date, Combination therapy, Metastases:  ION-01: A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer (clinicaltrials.gov) -  Nov 21, 2022   
    P2,  N=14, Completed, 
    Trial completion date: Jan 2023 --> Jul 2023 | Trial primary completion date: Jan 2023 --> Jul 2023 Active, not recruiting --> Completed | Trial completion date: Oct 2022 --> Feb 2022
  • ||||||||||  nemvaleukin alfa (ALKS 4230) / Alkermes, Keytruda (pembrolizumab) / Merck (MSD)
    Journal:  Potential IL2 Substitute Shrinks Solid Tumors. (Pubmed Central) -  Aug 10, 2022   
    As a monotherapy, the drug produced overall response rates of 13% in patients with advanced melanoma and 18.2% in advanced renal cell carcinoma. When combined with pembrolizumab, the drug produced responses in 16.1% of patients with various solid tumor types.
  • ||||||||||  nemvaleukin alfa (ALKS 4230) / Alkermes, Keytruda (pembrolizumab) / Merck (MSD)
    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. (Available On Demand; 481a) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_5437;    
    P3
    Pts must have received ≥1 prior line of systemic therapy in the platinum-sensitive setting, ≤5 prior lines in the platinum-resistant setting, and prior bevacizumab, with radiographic progression on most recent therapy...Approximately 376 pts will be randomized (3:1:1:3) to receive nemvaleukin 6 μg/kg IV on days 1-5 and pembrolizumab 200 mg IV on day 1 of each 21-day cycle, pembrolizumab monotherapy, nemvaleukin monotherapy, or chemotherapy (pegylated liposomal doxorubicin, paclitaxel, topotecan, or gemcitabine) and stratified according to PD-L1 status, histologic subtype (high-grade vs non–high-grade serous), and chemotherapy (paclitaxel vs other)...The primary endpoint is investigator-assessed PFS (RECIST v1.1) in the nemvaleukin/pembrolizumab vs chemotherapy group. Secondary/exploratory endpoints include overall survival, other antitumor measures, safety, health-related quality of life, and pharmacokinetic/pharmacodynamic effects.
  • ||||||||||  nemvaleukin alfa (ALKS 4230) / Alkermes
    ARTISTRY-6: Nemvaleukin alfa monotherapy in patients with advanced mucosal and cutaneous melanoma. (Available On Demand; 193a) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_3525;    
    P2
    The primary objective is to evaluate the antitumor activity of nemvaleukin monotherapy defined by overall response rate. Additional objectives include the evaluation of safety, health-related quality of life, predictive biomarkers, pharmacokinetics, immunogenicity, and pharmacodynamic effects.
  • ||||||||||  nemvaleukin alfa (ALKS 4230) / Mural Oncology
    Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  ARTISTRY-1: A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors (clinicaltrials.gov) -  Mar 31, 2022   
    P1/2,  N=243, Active, not recruiting, 
    Durable responses were observed with monotherapy and combination therapy in heavily pretreated pts across a range of tumors, warranting further investigation. Trial completion date: Mar 2022 --> Jan 2023 | Trial primary completion date: Mar 2022 --> Jan 2023