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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:
    3d
    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)
    13d
    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)
    14d
    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)
    24d
    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)
    1m
    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)
    1m
    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
    1m
    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)
    2ms
    A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=9, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=322 --> 9
    Enrollment closed • Enrollment change
    |
    Zynyz (retifanlimab-dlwr)
    2ms
    A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1, N=83, Terminated, Incyte Corporation | Active, not recruiting --> Terminated; The study was terminated after careful review of the overall clinical activity of this compound and a lack of robust efficacy. The study closure is not based on safety concerns.
    Trial termination
    |
    FLT3 (Fms-related tyrosine kinase 3) • MSI (Microsatellite instability) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    MSI-H/dMMR • FLT3-ITD mutation • IDH wild-type
    |
    Zynyz (retifanlimab-dlwr) • INCB81776
    2ms
    Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=61, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    3ms
    Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov)
    P1, N=12, Recruiting, Washington University School of Medicine | Trial completion date: Oct 2028 --> Jan 2030 | Trial primary completion date: Jan 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    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
    3ms
    Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=57, Terminated, Incyte Corporation | Completed --> Terminated; This was a strategic business decision. There were no safety concerns contributing to this decision.
    Trial termination
    |
    CD8 (cluster of differentiation 8)
    |
    Zynyz (retifanlimab-dlwr) • INCB106385 • uprevstobart (INCA00186)