^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    CD122 agonist

    Related drugs:
    15d
    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)
    18d
    Adoptive Cell Therapy Across Cancer Diagnoses (clinicaltrials.gov)
    P1/2, N=25, Completed, Inge Marie Svane | Unknown status --> Completed
    Trial completion
    |
    IL2 (Interleukin 2)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    18d
    An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=250, Active, not recruiting, Genentech, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab)
    28d
    Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients with Stage III-IV Melanoma (clinicaltrials.gov)
    P1, N=34, Active, not recruiting, M.D. Anderson Cancer Center | N=15 --> 34 | Trial completion date: Jun 2025 --> Oct 2027 | Trial primary completion date: Jun 2024 --> Oct 2027
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    NGFR (Nerve Growth Factor Receptor) • TGFA (Transforming Growth Factor Alpha)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    1m
    STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, City of Hope Medical Center
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    3ms
    Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer (clinicaltrials.gov)
    P1/2, N=47, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2024 --> Jul 2025
    Trial completion date • Combination therapy • Epigenetic controller • Metastases
    |
    mTOR (Mechanistic target of rapamycin kinase)
    |
    Jingzhuda (entinostat) • Proleukin (aldesleukin)
    4ms
    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)
    4ms
    A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=18, Completed, Genentech, Inc. | Recruiting --> Completed | N=60 --> 18 | Trial completion date: Jul 2026 --> Jun 2024 | Trial primary completion date: Jan 2026 --> Jun 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    4ms
    Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy (clinicaltrials.gov)
    P2, N=10, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial • Combination therapy • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • LTC004
    5ms
    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)
    5ms
    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)
    6ms
    Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors (clinicaltrials.gov)
    P1/2, N=180, Active, not recruiting, Alaunos Therapeutics | Trial completion date: Mar 2029 --> Nov 2024 | Trial primary completion date: Dec 2025 --> Nov 2024
    Trial completion date • Trial primary completion date • IO biomarker
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin)
    6ms
    An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=250, Recruiting, Genentech, Inc. | Trial completion date: Jun 2024 --> Sep 2025 | Trial primary completion date: Jun 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    Tecentriq (atezolizumab)
    6ms
    IL-15/IL-15Rα-Fc fusion protein XmAb24306 potentiates activity of CD3 bispecific antibodies through enhancing T cell expansion. (PubMed, Mol Cancer Ther)
    Activation of human peripheral T cells by cevostamab, an anti-FcRH5/CD3 TDB, or anti-HER2/CD3 TDB resulted in upregulation of IL-2/15Rβ (CD122) receptor subunit in nearly all CD8+ and majority of CD4+ T cells, suggesting that TDB treatment may sensitize T cells to the IL-15. In summary, our results support the hypothesis where the number of tumor infiltrating T cells is rate limiting for the activity of solid tumor targeting TDBs. Upregulation of CD122 by TDB treatment and the observed synergy with XmAb24306 and T cell bispecific antibodies supports clinical evaluation of this novel immunotherapy combination.
    Journal
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL15 (Interleukin 15)
    |
    cevostamab (RG6160)
    6ms
    Aerosolized Aldesleukin in Treating Patients With Lung Metastases (clinicaltrials.gov)
    P1, N=70, Active, not recruiting, M.D. Anderson Cancer Center | Phase classification: P1/2 --> P1 | Trial completion date: Apr 2024 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2026
    Phase classification • Trial completion date • Trial primary completion date
    |
    Proleukin (aldesleukin)
    6ms
    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)
    7ms
    Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (clinicaltrials.gov)
    P3, N=1449, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date
    |
    MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
    |
    Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
    7ms
    Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    NGFR (Nerve Growth Factor Receptor) • TGFA (Transforming Growth Factor Alpha)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    7ms
    CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma (clinicaltrials.gov)
    P2, N=16, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Apr 2024 | Trial primary completion date: Jan 2025 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2) • MLANA (Melan-A)
    |
    BRAF mutation • BRAF V600
    |
    Yervoy (ipilimumab) • cyclophosphamide • Proleukin (aldesleukin)
    8ms
    Efbalropendekin Alfa enhances human natural killer cell cytotoxicity against tumor cell lines in vitro. (PubMed, Front Immunol)
    Daratumumab (dara), a monoclonal antibody (mAb) that targets CD38 results in antibody-dependent cellular cytotoxicity (ADCC) of both multiple myeloma (MM) cells and NK cells. Because NK cells express CD38, XmAb24306 increases dara-mediated NK cell fratricide, but overall does not negatively impact the ADCC activity against a MM cell line likely due to increased NK cell activity of the surviving cells. These data show that XmAb24306 increases direct and ADCC-mediated human NK cell cytotoxicity in vitro.
    Preclinical • Journal • IO biomarker • Tumor cell
    |
    IL15 (Interleukin 15)
    |
    CD38 expression
    |
    Darzalex (daratumumab)
    8ms
    Non-Viral TCR Gene Therapy (clinicaltrials.gov)
    P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=210 --> 0 | Trial completion date: Dec 2029 --> Mar 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2028 --> Mar 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • IO biomarker • Gene therapy • Metastases
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    8ms
    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)
    9ms
    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)
    9ms
    Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer (clinicaltrials.gov)
    P1, N=210, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • SLATE-KRAS
    9ms
    ABILITY: A Beta-only IL-2 ImmunoTherapY Study (clinicaltrials.gov)
    P1/2, N=115, Recruiting, Medicenna Therapeutics, Inc. | Trial primary completion date: Sep 2024 --> Jun 2026
    Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    Keytruda (pembrolizumab) • MDNA11
    9ms
    Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer (clinicaltrials.gov)
    P1, N=210, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • SLATE-KRAS
    9ms
    Selective targeting or reprogramming of intra-tumoral Tregs. (PubMed, Med Oncol)
    Anti-CCR8 and the IL-2Rβγ agonist Bempegaldesleukin selectively target intra-tumoral Treg population, with the former approved to not elicit autoimmunity...Blimp-1 inhibitors and glucocorticoid-induced TNFR-related protein agonists are example approaches that can be used for diverting Treg differentiation into Th1-like CD4+ T cells, thereby powering immunogenicity against cancer. Finally, selective target of intra-tumoral Tregs and their reprogramming into effector T cells is applicable using low-dose chemotherapy, and high-salt and high-tryptophan diet.
    Review • Journal
    |
    CD4 (CD4 Molecule) • PRDM1 (PR/SET Domain 1) • CCR8 (C-C Motif Chemokine Receptor 8) • TRPS1 (Transcriptional Repressor GATA Binding 1)
    |
    bempegaldesleukin (NKTR-214)
    10ms
    Immunotherapy for the Treatment of Advanced Solid Tumor (clinicaltrials.gov)
    P1/2, N=40, Recruiting, Tongji Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    10ms
    Study of High Dose Interleukin-2 (IL-2) and Stereotactic Body Radiation (SBRT) in Patients With Metastatic Renal Cancer (clinicaltrials.gov)
    P2, N=84, Active, not recruiting, Providence Health & Services | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin)
    10ms
    Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients (clinicaltrials.gov)
    P1/2, N=8, Suspended, National Cancer Institute (NCI) | N=110 --> 8 | Recruiting --> Suspended
    Enrollment change • Trial suspension • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12V • HRAS mutation • KRAS G12 • NRAS G12 • HLA-A*11 • NRAS G12V
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    10ms
    Lymphodepletion Plus Adoptive Cell Transfer With High Dose IL-2 in Patients With Metastatic Melanoma (clinicaltrials.gov)
    P=N/A, N=19, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    IFNG (Interferon, gamma)
    |
    cyclophosphamide • Proleukin (aldesleukin)
    11ms
    T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer (clinicaltrials.gov)
    P1/2, N=8, Completed, M.D. Anderson Cancer Center | Suspended --> Completed
    Trial completion • Combination therapy
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • PRAME (Preferentially Expressed Antigen In Melanoma) • COL6A3 (Collagen Type VI Alpha 3 Chain)
    |
    PRAME expression
    |
    cyclophosphamide • Proleukin (aldesleukin) • utomilumab (PF-05082566)
    11ms
    Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2024
    Trial completion date • Trial primary completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    11ms
    CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma (clinicaltrials.gov)
    P2, N=16, Active, not recruiting, M.D. Anderson Cancer Center | N=30 --> 16 | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2) • MLANA (Melan-A)
    |
    BRAF mutation • BRAF V600
    |
    Yervoy (ipilimumab) • cyclophosphamide • Proleukin (aldesleukin)
    12ms
    Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis (clinicaltrials.gov)
    P1, N=15, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • oxaliplatin • leucovorin calcium • Proleukin (aldesleukin) • fluorouracil topical
    12ms
    Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Mayo Clinic | Phase classification: P1b --> P1
    Phase classification
    |
    Opdivo (nivolumab) • oxaliplatin • leucovorin calcium • Proleukin (aldesleukin) • fluorouracil topical
    12ms
    An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=250, Recruiting, Genentech, Inc. | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab)
    1year
    NYESO SCT: Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer (clinicaltrials.gov)
    P1, N=5, Terminated, Jonsson Comprehensive Cancer Center | N=12 --> 5 | Trial completion date: Aug 2024 --> Oct 2023 | Recruiting --> Terminated; slow accrual
    Enrollment change • Trial completion date • Trial termination • Metastases
    |
    CTAG1B (Cancer/testis antigen 1B) • CD34 (CD34 molecule)
    |
    fludarabine IV • Proleukin (aldesleukin) • busulfan • Neupogen (filgrastim) • plerixafor
    1year
    Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results. (PubMed, J Clin Oncol)
    The PIVOT IO 001 study did not meet its primary end points of ORR, PFS, and OS. Increased toxicity was observed with BEMPEG plus NIVO versus NIVO.
    P3 data • Journal • Metastases
    |
    IL2 (Interleukin 2)
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)
    1year
    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 | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Sep 2023
    Trial completion • Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)
    1year
    Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=78, Recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2025 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Sep 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Proleukin (aldesleukin)
    1year
    PIVOT IO 009: A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer (clinicaltrials.gov)
    P3, N=114, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Jun 2023
    Trial completion • Trial completion date
    |
    Opdivo (nivolumab) • bempegaldesleukin (NKTR-214)