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    DRUG:

    bempegaldesleukin (NKTR-214)

    i
    Other names: NKTR-214, NKTR 214, multi-PEGylated IL2 conjugate, NKTR214, BMS-986321, ONO-7911, BEMPEG
    Company:
    BMS, Nektar Therap, Ono Pharma
    Drug class:
    IL-2 stimulant, CD122 agonist
    Related drugs:
    3ms
    A Prospective, Single-arm, Multicenter Exploratory Clinical Study of Anlotinib Combined With Bempegaldesleukin and Conventional Chemoradiotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Soft Tissue Sarcoma. (clinicaltrials.gov)
    P2, N=46, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    Focus V (anlotinib) • doxorubicin hydrochloride • bempegaldesleukin (NKTR-214)
    6ms
    A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Anlotinib Hydrochloride Capsules Combined with Bempegaldesleukin as First-Line Treatment for Advanced Pheochromocytoma/Paraganglioma (ChiCTR2500102436)
    P2, N=22, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P2 trial
    |
    Focus V (anlotinib) • bempegaldesleukin (NKTR-214)
    7ms
    A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)
    8ms
    Exploring the Dynamics of Immune Checkpoint Inhibitor-Induced Eosinophilia in Advanced/Metastatic Melanoma: A Comprehensive Retrospective Analysis. (PubMed, Cancer Med)
    This study marks the first comprehensive approach of the relationship between the type of immunotherapy and the incidence of eosinophilia in melanoma patients. It also delves into the patients' baseline characteristics, diagnostic assessment, management, and prognosis, providing useful guidance for physicians treating patients with ICIs.
    Retrospective data • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • bempegaldesleukin (NKTR-214)
    10ms
    Clinical and Translational Results from PORTER, a Multi-cohort Phase 1 Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer. (PubMed, Clin Cancer Res)
    Cohort B, which combined radiation therapy with CDX-301, poly-ICLC, and nivolumab, demonstrated encouraging clinical activity. Pre-existing rather than treatment-induced immune activation was associated with clinical benefit across cohorts, highlighting the importance of baseline immune fitness.
    P1 data • Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214) • Hiltonol (poly-ICLC) • Mobista (CDX-301)
    1year
    Bempegaldesleukin plus nivolumab in first-line advanced/metastatic urothelial carcinoma: Results from a phase II single-arm study (PIVOT-10). (PubMed, Urol Oncol)
    BEMPEG plus NIVO did not meet the efficacy threshold for ORR in patients with previously untreated locally advanced or metastatic urothelial carcinoma and low PD-L1 expression.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • IL2 (Interleukin 2)
    |
    PD-L1 expression • PD-L1 underexpression • PD-L1-L
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)
    over1year
    Baseline biomarkers of efficacy and on-treatment immune-profile changes associated with bempegaldesleukin plus nivolumab. (PubMed, NPJ Precis Oncol)
    Changes in tumor biomarkers were comparable between arms. These biomarker results help provide a better understanding of the mechanism of action of BEMPEG + NIVO and may help contextualize the clinical observations from PIVOT IO 001.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker
    |
    TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)
    over1year
    PIVOT IO 001: A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma (clinicaltrials.gov)
    P3, N=783, Completed, Bristol-Myers Squibb | Trial completion date: Sep 2023 --> Mar 2024
    Trial completion date • Metastases
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)
    over1year
    Bempegaldesleukin Plus Nivolumab Versus Sunitinib or Cabozantinib in Previously Untreated Advanced Clear Cell Renal Cell Carcinoma: A Phase III Randomized Study (PIVOT-09). (PubMed, J Clin Oncol)
    First-line BEMPEG plus NIVO for advanced/metastatic ccRCC did not improve efficacy in patients with intermediate-/poor-risk disease but led to fewer grade 3/4 TRAEs versus TKI.
    P3 data • Journal • Metastases
    |
    IL2 (Interleukin 2)
    |
    Opdivo (nivolumab) • sunitinib • Cabometyx (cabozantinib tablet) • bempegaldesleukin (NKTR-214)
    over1year
    A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)
    over1year
    A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19 (clinicaltrials.gov)
    P1, N=30, Completed, Nektar Therapeutics | Phase classification: P1b --> P1
    Phase classification
    |
    bempegaldesleukin (NKTR-214)
    almost2years
    PIVOT IO 011: A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread (clinicaltrials.gov)
    P1, N=30, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Cabometyx (cabozantinib tablet) • Inlyta (axitinib) • bempegaldesleukin (NKTR-214)