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    DRUG:

    Zynyz (retifanlimab-dlwr)

    i
    Other names: INCMGA0012, MGA 012, MGA012, INCMGA 0012 , INCMGA00012, ZL-1306
    Company:
    Incyte, MacroGenics
    Drug class:
    PD1 inhibitor
    Related drugs:
    2d
    Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
    P1/2, N=67, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition • Checkpoint block • Metastases
    |
    gemcitabine • docetaxel • Zynyz (retifanlimab-dlwr)
    4d
    Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas (clinicaltrials.gov)
    P2, N=51, Active, not recruiting, Washington University School of Medicine | Trial primary completion date: Apr 2024 --> Jul 2024
    Trial primary completion date • Combination therapy
    |
    Avastin (bevacizumab) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360)
    5d
    A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI) (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Lund University Hospital
    New P2 trial • Metastases
    |
    Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr)
    11d
    Merkel Cell Carcinoma: Integrating Epidemiology, Immunology, and Therapeutic Updates. (PubMed, Am J Clin Dermatol)
    Starting in 2017, four programmed cell death protein 1 (PD-1)/programmed cell death-ligand 1 (PD-L1) immune checkpoint inhibitors-avelumab, pembrolizumab, nivolumab (utilized in both neoadjuvant and adjuvant settings), and retifanlimab-have demonstrated efficacy in treating patients with disseminated MCC on the basis of prospective clinical trials. Nevertheless, while randomized studies directly comparing immune checkpoint inhibitors and chemotherapy in MCC are lacking, immunotherapy shows response rates comparable to those previously reported with chemotherapy but with more enduring responses. Notably, adjuvant nivolumab has proven superiority to the standard-of-care therapy (observation) in the adjuvant setting.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Bavencio (avelumab) • Zynyz (retifanlimab-dlwr)
    15d
    The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies. (clinicaltrials.gov)
    P2, N=10, Terminated, Incyte Corporation | Active, not recruiting --> Terminated; A business decision due to availability of commercial drug and other options for accessing study drug treatment.
    Trial termination • Metastases
    |
    Keytruda (pembrolizumab) • Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr)
    29d
    NCI-2020-02940: INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study (clinicaltrials.gov)
    P2, N=25, Recruiting, Mridula George, MD | Trial primary completion date: Jan 2024 --> Jun 2024
    Trial primary completion date • Oncolytic virus • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PD-L1 expression • HER-2 expression • ER expression
    |
    Irene (pyrotinib) • Zynyz (retifanlimab-dlwr) • Reolysin (pelareorep)
    1m
    Atezolizumab plus modified docetaxel, cisplatin, and fluorouracil as first-line treatment for advanced anal cancer (SCARCE C17-02 PRODIGE 60): a randomised, non-comparative, phase 2 study. (PubMed, Lancet Oncol)
    Despite a higher incidence of adverse events, combining atezolizumab with mDCF is feasible, with similar dose intensity in both groups, although the primary efficacy endpoint was not met. The predictive value of a PD-L1 combined positive score of 5 or greater now needs to be confirmed in future studies.
    P2 data • Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tecentriq (atezolizumab) • docetaxel • 5-fluorouracil • Bavencio (avelumab) • Zynyz (retifanlimab-dlwr)
    1m
    Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=38, Not yet recruiting, OHSU Knight Cancer Institute
    New P1/2 trial • Combination therapy • Metastases
    |
    paclitaxel • Zynyz (retifanlimab-dlwr) • axatilimab (SNDX-6352)
    1m
    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=50, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Zynyz (retifanlimab-dlwr) • SX-682 • Anktiva (nogapendekin alfa inbakicept-pmln)
    2ms
    INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=54, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    CD8 (cluster of differentiation 8)
    |
    Zynyz (retifanlimab-dlwr) • INCB106385
    2ms
    PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, University of Alabama at Birmingham
    New P1 trial • CAR T-Cell Therapy • Checkpoint inhibition • Checkpoint block
    |
    Zynyz (retifanlimab-dlwr) • INCAGN2390 • tuparstobart (INCAGN2385)
    2ms
    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 | Initiation date: Oct 2023 --> Feb 2024
    Trial initiation date • Metastases
    |
    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
    A phase II study of retifanlimab, a humanized anti-PD-1 monoclonal antibody, in patients with solid tumors (POD1UM-203). (PubMed, ESMO Open)
    Retifanlimab demonstrated durable antitumor activity in patients with melanoma, NSCLC, UC, or RCC. The efficacy and safety of retifanlimab were as expected for a PD-(L)1 inhibitor. These data support further study of retifanlimab in solid tumors.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr)
    3ms
    Optimus: An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=30, Terminated, Incyte Corporation | Trial completion date: Jun 2024 --> Jan 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Jan 2024; Business Decision. No safety concerns contributed to this decision.
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • INCAGN2390 • tuparstobart (INCAGN2385)
    4ms
    The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies. (clinicaltrials.gov)
    P2, N=10, Active, not recruiting, Incyte Corporation | Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr)
    4ms
    A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation (clinicaltrials.gov)
    P1, N=322, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • Zynyz (retifanlimab-dlwr)
    4ms
    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 • Trial primary completion date • Combination therapy • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
    |
    temozolomide • carmustine • Zynyz (retifanlimab-dlwr)
    4ms
    Study of INCA 0186 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=57, Active, not recruiting, Incyte Corporation | Trial completion date: Jan 2024 --> Jun 2025 | Trial primary completion date: Jan 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CD8 (cluster of differentiation 8)
    |
    Zynyz (retifanlimab-dlwr) • INCA00186 • INCB106385
    4ms
    MAHOGANY: Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (clinicaltrials.gov)
    P2/3; Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
    Combination therapy • Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    PD-L1 expression • HER-2 positive
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Herceptin (trastuzumab) • 5-fluorouracil • capecitabine • oxaliplatin • Margenza (margetuximab-cmkb) • Zynyz (retifanlimab-dlwr) • tebotelimab (MGD013)
    5ms
    A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation (clinicaltrials.gov)
    P1, N=322, Not yet recruiting, Incyte Corporation
    New P1 trial • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • Zynyz (retifanlimab-dlwr)
    5ms
    A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1, N=84, Active, not recruiting, Incyte Corporation | Phase classification: P1a/1b --> P1 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    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 • FLT3 wild-type • IDH wild-type
    |
    Zynyz (retifanlimab-dlwr) • INCB81776
    5ms
    Retifanlimab With Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma (clinicaltrials.gov)
    P2, N=134, Not yet recruiting, Academic and Community Cancer Research United
    New P2 trial • Combination therapy
    |
    Avastin (bevacizumab) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Zynyz (retifanlimab-dlwr)
    5ms
    A phase 1 trial of combined MEK, STAT3 and PD-1 inhibition in metastatic pancreatic ductal adenocarcinoma (PDAC). (ASCO-GI 2024)
    NCT05440942 is an open-label, prospective, single-institution phase 1 trial testing the safety, preliminary efficacy, and biomarkers of response to the combination of trametinib (MEKi), ruxolitinib (JAK2/STAT3 inhibitor) and retifanlimab (PD-1 inhibitor) in patients with metastatic PDAC. These results will be correlated with clinical response to therapy to determine biomarkers of response and resistance. Clinical trial information: NCT05440942.
    P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    JAK2 (Janus kinase 2) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • STAT3 (Signal Transducer And Activator Of Transcription 3) • CD34 (CD34 molecule) • CXCL1 (Chemokine (C-X-C motif) ligand 1)
    |
    Mekinist (trametinib) • Jakafi (ruxolitinib) • Zynyz (retifanlimab-dlwr)
    5ms
    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=50, Not yet recruiting, National Cancer Institute (NCI)
    New P1/2 trial • Metastases
    |
    Zynyz (retifanlimab-dlwr) • SX-682 • Anktiva (nogapendekin alfa inbakicept-pmln)
    5ms
    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, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=146 --> 61
    Enrollment closed • Enrollment change
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Zynyz (retifanlimab-dlwr) • INCAGN2390 • tuparstobart (INCAGN2385)
    6ms
    NCI-2020-02940: INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study (clinicaltrials.gov)
    P2, N=25, Recruiting, Mridula George, MD | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Jun 2023 --> Jan 2024
    Trial completion date • Trial primary completion date • Oncolytic virus • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PD-L1 expression • HER-2 expression • ER expression
    |
    Irene (pyrotinib) • Zynyz (retifanlimab-dlwr) • Reolysin (pelareorep)
    6ms
    Optimus: An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=45 --> 30
    Enrollment closed • Enrollment change • Combination therapy
    |
    Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • INCAGN2390 • tuparstobart (INCAGN2385)
    6ms
    Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=35, Recruiting, Peter Hosein, MD | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability)
    |
    BRCA2 mutation • BRCA1 mutation • MSI-H/dMMR
    |
    Mekinist (trametinib) • Jakafi (ruxolitinib) • Zynyz (retifanlimab-dlwr)
    6ms
    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 | Not yet recruiting --> Recruiting
    Enrollment open
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MGMT (6-O-methylguanine-DNA methyltransferase) • CD8 (cluster of differentiation 8)
    |
    IDH2 mutation • MGMT promoter methylation • IDH wild-type
    |
    Zynyz (retifanlimab-dlwr) • neoantigen DNA vaccine
    6ms
    POD1UM-204: Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (clinicaltrials.gov)
    P2, N=300, Recruiting, Incyte Corporation | Trial completion date: Jun 2025 --> May 2026 | Trial primary completion date: Aug 2023 --> Apr 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
    |
    PD-L1 expression • MSI-H/dMMR • FGFR mutation • FGFR1 mutation
    |
    Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • INCAGN2390 • tuparstobart (INCAGN2385)
    6ms
    RiLEY: 9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, Anwaar Saeed | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial primary completion date • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • Zynyz (retifanlimab-dlwr) • elraglusib (9-ING-41)
    6ms
    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 | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    7ms
    BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov)
    P3, N=404, Not yet recruiting, BriaCell Therapeutics Corporation
    New P3 trial • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    7ms
    Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov)
    P1/2, N=36, Enrolling by invitation, BriaCell Therapeutics Corporation | Recruiting --> Enrolling by invitation
    Enrollment status • Combination therapy • Metastases
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 negative • PGR positive • PGR negative
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    8ms
    Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=35, Active, not recruiting, Peter Hosein, MD | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability)
    |
    BRCA2 mutation • BRCA1 mutation • MSI-H/dMMR
    |
    Mekinist (trametinib) • Jakafi (ruxolitinib) • Zynyz (retifanlimab-dlwr)
    8ms
    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=146, Recruiting, Incyte Corporation | Trial primary completion date: Jul 2023 --> Aug 2025
    Trial primary completion date • Combination therapy • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Zynyz (retifanlimab-dlwr) • INCAGN2390 • tuparstobart (INCAGN2385)
    9ms
    Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, Washington University School of Medicine | Trial completion date: Jun 2027 --> Oct 2027 | Initiation date: Jun 2023 --> Oct 2023 | Trial primary completion date: Sep 2024 --> Jan 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MGMT (6-O-methylguanine-DNA methyltransferase) • CD8 (cluster of differentiation 8)
    |
    IDH2 mutation • MGMT promoter methylation • IDH wild-type
    |
    Zynyz (retifanlimab-dlwr) • neoantigen DNA vaccine
    9ms
    Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC (clinicaltrials.gov)
    P1, N=56, Active, not recruiting, Providence Health & Services | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Zynyz (retifanlimab-dlwr) • DPV-001 • ragifilimab (INCAGN1876)
    9ms
    Updated results from POD1UM-201: A phase II study of retifanlimab in patients with advanced or metastatic Merkel cell carcinoma (MCC) (ESMO 2023)
    Efficacy and safety results for the full study population will be presented. Conclusions Retifanlimab has shown notable clinical activity with an acceptable safety in advanced/metastatic chemotherapy-naive MCC, and is a promising new treatment option for eligible pts.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr)
    9ms
    Retifanlimab in patients with recurrent microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) endometrial cancer: Final results from the POD1UM-101 study (Cohort H) (ESMO 2023)
    Final results for this cohort including safety and secondary efficacy endpoints will be presented. Conclusions Retifanlimab has shown notable clinical activity in previously treated MSI-H or dMMR endometrial cancer, which is consistent with other checkpoint immunotherapies.
    Clinical • Mismatch repair • Microsatellite instability
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Zynyz (retifanlimab-dlwr)
    10ms
    A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1a/1b, N=84, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=140 --> 84
    Enrollment closed • Enrollment change • Metastases
    |
    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 • FLT3 wild-type • IDH wild-type
    |
    Zynyz (retifanlimab-dlwr) • INCB81776
    10ms
    Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas (clinicaltrials.gov)
    P2, N=49, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | Trial completion date: Apr 2028 --> Apr 2026 | Trial primary completion date: Jan 2025 --> Apr 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    Avastin (bevacizumab) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360)