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    DRUG:

    Zynyz (retifanlimab-dlwr)

    i
    Other names: INCMGA0012, MGA 012, MGA012, ZL1306, MGA-012, NCMGA-0012, INCMGA 0012 , INCMGA00012, ZL-1306, ZL 1306
    Company:
    Incyte, Knight Therap, MacroGenics, Sagard Healthcare
    Drug class:
    PD1 inhibitor
    Related drugs:
    19d
    MERCURY: Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery (clinicaltrials.gov)
    P2, N=36, Active, not recruiting, Gruppo Oncologico del Nord-Ovest | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • carboplatin • etoposide IV • Zynyz (retifanlimab-dlwr)
    21d
    PRISM: Retifanlimab and Ruxolitinib In Solid Malignancies (clinicaltrials.gov)
    P1/2, N=40, Recruiting, University of California, San Diego | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Jakafi (ruxolitinib) • Zynyz (retifanlimab-dlwr)
    25d
    Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma (clinicaltrials.gov)
    P1, N=50, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jan 2027 --> Jan 2029 | Trial primary completion date: Jan 2026 --> Jan 2028
    Trial completion date • Trial primary completion date
    |
    temozolomide • carmustine • Zynyz (retifanlimab-dlwr)
    27d
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jan 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    2ms
    Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov)
    P1, N=27, Recruiting, Washington University School of Medicine | N=12 --> 27
    Enrollment change
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH2 mutation • MGMT promoter methylation • IDH wild-type
    |
    Zynyz (retifanlimab-dlwr) • neoantigen DNA vaccine
    2ms
    Tumor and Immune Dynamics Following Sequential CDK4/6 and PD-1 Inhibition: Results from a Phase 2 Study in Dedifferentiated Liposarcoma. (PubMed, Cancer Res Commun)
    A palbociclib lead-in prior to retifanlimab had a high rate of immune-related toxicities. Correlative analyses identified changes in tumor and immune cells attributable to treatment. A study of concurrent dosing of the combination is ongoing.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3) • CD38 (CD38 Molecule) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
    |
    Ibrance (palbociclib) • Zynyz (retifanlimab-dlwr)
    2ms
    Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas (clinicaltrials.gov)
    P2, N=51, Completed, Washington University School of Medicine | Active, not recruiting --> Completed | Trial completion date: Apr 2026 --> Oct 2025
    Trial completion • Trial completion date
    |
    Avastin (bevacizumab) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360)
    2ms
    Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov)
    P1/2, N=60, Recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2028 --> Oct 2030 | Trial primary completion date: Oct 2025 --> Oct 2027
    Trial completion date • Trial primary completion date
    |
    Zynyz (retifanlimab-dlwr) • SX-682 • Anktiva (nogapendekin alfa inbakicept-pmln)
    3ms
    A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P1, N=24, Recruiting, M.D. Anderson Cancer Center | Phase classification: P1/2 --> P1 | Not yet recruiting --> Recruiting
    Enrollment open • Phase classification
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Niktimvo (axatilimab-csfr)
    3ms
    Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). (clinicaltrials.gov)
    P3, N=308, Completed, Incyte Corporation | Active, not recruiting --> Completed | Trial completion date: Mar 2026 --> Sep 2025
    Trial completion • Trial completion date
    |
    CD4 (CD4 Molecule)
    |
    carboplatin • paclitaxel • Zynyz (retifanlimab-dlwr)
    3ms
    INCB161734-101: A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation (clinicaltrials.gov)
    P1, N=710, Recruiting, Incyte Corporation | N=466 --> 710
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • 5-fluorouracil • irinotecan • leucovorin calcium • Zynyz (retifanlimab-dlwr) • INCA33890
    3ms
    PRISM: Retifanlimab and Ruxolitinib In Solid Malignancies (clinicaltrials.gov)
    P1/2, N=40, Not yet recruiting, University of California, San Diego
    New P1/2 trial • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Jakafi (ruxolitinib) • Zynyz (retifanlimab-dlwr)