^
    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
    7ms
    A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1, N=84, Active, not recruiting, Incyte Corporation | Trial completion date: Apr 2025 --> Sep 2025 | Trial primary completion date: Apr 2025 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    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
    12ms
    A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1, N=84, Active, not recruiting, Incyte Corporation | Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Nov 2024 --> Apr 2025
    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
    |
    Zynyz (retifanlimab-dlwr) • INCB81776
    over1year
    Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=12, Recruiting, University of Wisconsin, Madison | Trial completion date: Aug 2026 --> Jul 2027
    Trial completion date • Checkpoint inhibition • Checkpoint block • Metastases
    |
    Keytruda (pembrolizumab) • INCB81776
    over1year
    Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=12, Recruiting, University of Wisconsin, Madison | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • INCB81776
    over1year
    Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, University of Wisconsin, Madison
    New P1 trial • Checkpoint inhibition • Checkpoint block • Metastases
    |
    Keytruda (pembrolizumab) • INCB81776
    almost2years
    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
    over2years
    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
    over2years
    Dual Axl/MerTK inhibitor INCB081776 creates a proinflammatory tumor immune microenvironment and enhances anti-PDL1 efficacy in head and neck cancer. (PubMed, Head Neck)
    This data indicates that simultaneous targeting of Axl and MerTK with INCB081776, either alone or in combination with anti-PDL1, slows tumor growth and creates a proinflammatory TIME in mouse models of HNC.
    Journal
    |
    AXL (AXL Receptor Tyrosine Kinase) • MERTK (MER Proto-Oncogene, Tyrosine Kinase)
    |
    AXL overexpression • MERTK expression
    |
    INCB81776
    over3years
    A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1a/1b, N=140, Recruiting, Incyte Corporation | Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: May 2023 --> Aug 2023
    Trial completion date • Trial primary completion date
    |
    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
    over3years
    A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1a/1b, N=180, Recruiting, Incyte Corporation | Trial completion date: Sep 2022 --> May 2023 | Trial primary completion date: Sep 2022 --> May 2023
    Trial completion date • Trial primary completion date
    |
    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
    over3years
    Simultaneous inhibition of Axl and MerTK enhances anti-PDL1 efficacy and creates a pro-inflammatory tumor immune microenvironment in head and neck cancer (AACR 2022)
    Finally, the combination of INCB081776 and anti-PDL1 was superior to either treatment alone in slowing tumor growth. Together, these studies indicate that INCB081776 cooperates with anti-PDL1 in a syngeneic mouse model of HNC to slow tumor growth and create a pro-inflammatory environment, especially in immunologically cold tumors, thereby highlighting the potential clinical benefit of this therapeutic combination.
    Clinical
    |
    CD8 (cluster of differentiation 8) • MERTK (MER Proto-Oncogene, Tyrosine Kinase)
    |
    MERTK expression
    |
    INCB81776