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    DRUG:

    verzistobart (INCAGN2390)

    i
    Other names: INCAGN2390, INCAGN 02390, INCAGN-2390, INCAGN02390, NCAGN-2390, INCAGN-02390, INCAGN 2390, NCAGN2390, NCAGN 2390
    Associations

    News

    Trials
    Company:
    Agenus, Incyte, Xoma
    Drug class:
    TIM-3 inhibitor
    Related drugs:
    Associations

    News

    Trials
    2ms
    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=206, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=300 --> 206
    Enrollment closed • Enrollment change • 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) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    3ms
    PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL (clinicaltrials.gov)
    P1, N=0, Withdrawn, University of Alabama at Birmingham | N=18 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • CAR T-Cell Therapy • Checkpoint inhibition • Checkpoint block
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    4ms
    Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P2, N=176, Active, not recruiting, Incyte Biosciences International Sàrl | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: May 2024 --> Feb 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    9ms
    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) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    9ms
    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) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    12ms
    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) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    1year
    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) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    1year
    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) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    1year
    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) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over1year
    Phase 2 trial of retifanlimab (anti–PD-1) in combination with INCAGN02385 (anti–LAG-3) and INCAGN02390 (anti–TIM-3) as first-line treatment in patients with PD-L1–positive recurrent/metastatic squamous cell carcinoma of the head and neck. (ASCO 2023)
    Patient enrollment is ongoing. Clinical trial information: NCT05287113.
    Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • LAG3 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    2years
    Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P2, N=162, Recruiting, Incyte Biosciences International Sàrl | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    2years
    A PHASE 2 UMBRELLA STUDY OF RETIFANLIMAB (INCMGA00012) ALONE OR IN COMBINATION WITH OTHER THERAPIES IN PATIENTS WITH ADVANCED OR METASTATIC ENDOMETRIAL CANCER (POD1UM-204) (IGCS 2022)
    Approximately 220 patients enroll into 4 treatment Groups: A—CPI-naive MSI-H EC receiving retifanlimab monotherapy (up to 100 patients); B—CPI-naive dMMR or POLE-positive EC receiving retifanlimab monotherapy (up to 40 patients); D—EC with activating fibroblast growth factor receptor (FGFR1, 2 or 3) mutations or alterations outside of the kinase domain and regardless of prior CPI treatment receiving retifanlimab plus pemigatinib (up to 40 patients); F—CPI-experienced MSI-H EC receiving retifanlimab, INCAGN02385 (LAG-3 inhibitor), and INCAGN02390 (TIM-3 inhibitor) (up to 40 patients). Trial in progress: there are no available conclusions at the time of submission.
    Clinical • P2 data • Combination therapy • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    MSI (Microsatellite instability) • FGFR1 (Fibroblast growth factor receptor 1) • LAG3 (Lymphocyte Activating 3) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    MSI-H/dMMR • FGFR1 mutation
    |
    Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    2years
    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: Aug 2023 --> Jun 2025
    Trial completion date • Combination therapy
    |
    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) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    2years
    Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P2, N=162, Not yet recruiting, Incyte Biosciences International Sàrl | Trial primary completion date: Jan 2024 --> Apr 2024
    Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over2years
    A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Estudio an fase II, aleatorizado, doble ciego y multicéntrico de retifanlimab en combinación con INCAGN02385 e INCAGN02390 como tratamiento de primera línea en participantes con carcinoma escamoso de cabeza y cuello metastásico/recidivante . (clinicaltrialsregister.eu)
    P2, N=162, Ongoing, Incyte Biosciences International Sarl
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over2years
    Phase II trial of retifanlimab (anti–PD-1) in combination with INCAGN02385 (anti–LAG-3) and INCAGN02390 (anti-TIM-3) as first-line treatment in patients with PD-L1-positive recurrent/metastatic squamous cell carcinoma of the head and neck (ESMO 2022)
    The primary endpoint is progression-free survival (defined per Response Evaluation Criteria in Solid Tumors [RECIST] v1.1). Secondary endpoints are objective response per RECIST v1.1, duration of response, disease control, overall survival and safety.
    Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • LAG3 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over2years
    First-in-human phase I study of INCAGN02390, a TIM-3 monoclonal antibody antagonist in patients with advanced malignancies (ESMO 2022)
    Conclusions INCAGN02390 monotherapy was generally well tolerated, with linear PK. The 400 mg Q2W dose is selected for further investigation in phase 1b/2 studies in combinations with other immunotherapies (NCT04370704, NCT05287113).
    Clinical • P1 data
    |
    HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    verzistobart (INCAGN2390)
    over2years
    Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P2, N=162, Not yet recruiting, Incyte Biosciences International Sàrl | Trial completion date: May 2025 --> May 2024
    Trial completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over2years
    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=144, Recruiting, Incyte Corporation | N=68 --> 144
    Enrollment change • Combination therapy
    |
    BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
    |
    BRAF mutation • LAG3 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over2years
    Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P2, N=162, Not yet recruiting, Incyte Biosciences International Sàrl
    New P2 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over2years
    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=68, Recruiting, Incyte Corporation | N=52 --> 68 | Trial completion date: Sep 2023 --> Oct 2025
    Enrollment change • Trial completion date • Combination therapy
    |
    BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
    |
    BRAF mutation • LAG3 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    almost3years
    A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies (clinicaltrials.gov)
    P1, N=40, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    verzistobart (INCAGN2390)
    over3years
    A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies (clinicaltrials.gov)
    P1, N=40, Active, not recruiting, Incyte Corporation | Trial completion date: Feb 2021 --> Sep 2021 | Trial primary completion date: Feb 2021 --> Sep 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    verzistobart (INCAGN2390)
    4years
    A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies (clinicaltrials.gov)
    P1, N=40, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    verzistobart (INCAGN2390)
    4years
    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=52, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
    |
    BRAF mutation • LAG3 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)
    over4years
    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=52, Not yet recruiting, Incyte Corporation
    New P1/2 trial • Combination therapy
    |
    BRAF (B-raf proto-oncogene) • LAG3 (Lymphocyte Activating 3)
    |
    BRAF mutation • LAG3 expression
    |
    Zynyz (retifanlimab-dlwr) • tuparstobart (INCAGN2385) • verzistobart (INCAGN2390)