^
    8d
    Open-label, single-arm, phase 2 trial to investigate the efficacy of sitravatinib plus tislelizumab combination as a second-line treatment for advanced biliary tract cancer. (PubMed, J Hepatol)
    Sitravatinib/tislelizumab combination as second-line treatment in patients with advanced BTC demonstrated meaningful efficacy and an acceptable safety profile. Patient selection using HRD biomarkers may be a promising strategy in this setting.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HRD (Homologous Recombination Deficiency)
    |
    HRD
    |
    Tevimbra (tislelizumab-jsgr) • sitravatinib (MGCD516)
    1m
    SAPPHIRE: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=577, Completed, Mirati Therapeutics Inc. | Active, not recruiting --> Completed
    Trial completion • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • docetaxel • sitravatinib (MGCD516)
    2ms
    Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study (clinicaltrials.gov)
    P2/3, N=52, Completed, Mirati Therapeutics Inc. | Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Sep 2025
    Trial completion • Trial completion date
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • Padcev (enfortumab vedotin-ejfv) • sitravatinib (MGCD516)
    5ms
    SAPPHIRE: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=577, Active, not recruiting, Mirati Therapeutics Inc. | Trial completion date: Jun 2025 --> Oct 2025
    Trial completion date • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • docetaxel • sitravatinib (MGCD516)
    5ms
    Sitravatinib combined with venetoclax exerts effective synergy to eliminate acute myeloid leukemia cells with FLT3-ITD mutations. (PubMed, Transl Oncol)
    The combination of venetoclax and FLT3 inhibitors gilteritinib and quizartinib has shown promising results in reducing leukemia burden and improving survival in pre-clinical studies and clinical trials of AML with FLT3 mutation. Finally, we tested the potential application of sitravatinib plus venetoclax in vivo using patient-derived xenografts, and found that the combined therapy was significantly more effective in inhibiting leukemia cell expansion, reducing infiltration in the spleen, and prolonging survival time compared to a single administration. Our study demonstrates the potential use of sitravatinib plus venetoclax as an alternative therapeutic strategy to treat AML patients with FLT3-ITD mutation.
    Journal
    |
    FLT3 (Fms-related tyrosine kinase 3) • MCL1 (Myeloid cell leukemia 1) • BCL2L1 (BCL2-like 1)
    |
    FLT3-ITD mutation • FLT3 mutation
    |
    Venclexta (venetoclax) • Xospata (gilteritinib) • Vanflyta (quizartinib) • sitravatinib (MGCD516)
    7ms
    National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=423, Active, not recruiting, University of Birmingham | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • IO biomarker
    |
    NKX2-1 (NK2 Homeobox 1) • TP63 (Tumor protein 63)
    |
    Xalkori (crizotinib) • Tagrisso (osimertinib) • Ibrance (palbociclib) • Imfinzi (durvalumab) • docetaxel • Koselugo (selumetinib) • Truqap (capivasertib) • fexagratinib (ABSK091) • ceralasertib (AZD6738) • sitravatinib (MGCD516) • vistusertib (AZD2014)
    7ms
    SITISVEAL: Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases. (clinicaltrials.gov)
    P2, N=16, Completed, Grupo Español Multidisciplinar de Melanoma | Active, not recruiting --> Completed
    Trial completion
    |
    Tevimbra (tislelizumab-jsgr) • sitravatinib (MGCD516)
    7ms
    Sitravatinib targets TYRO3 to augment the anti-tumor immune response of PD-1 blockade in hepatocellular carcinoma. (PubMed, Clin Cancer Res)
    Collectively, we demonstrated a rationale for combining sitravatinib with PD-1 blockade in the treatment for HCC.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    MET (MET proto-oncogene, receptor tyrosine kinase) • CD8 (cluster of differentiation 8) • AXL (AXL Receptor Tyrosine Kinase) • MERTK (MER Proto-Oncogene, Tyrosine Kinase) • TYRO3 (TYRO3 Protein Tyrosine Kinase) • STAT1 (Signal Transducer And Activator Of Transcription 1) • IL33 (Interleukin 33)
    |
    sitravatinib (MGCD516)
    8ms
    SITISVEAL: Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases. (clinicaltrials.gov)
    P2, N=16, Active, not recruiting, Grupo Español Multidisciplinar de Melanoma | Trial completion date: May 2024 --> Aug 2025
    Trial completion date
    |
    Tevimbra (tislelizumab-jsgr) • sitravatinib (MGCD516)
    8ms
    SAPPHIRE: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=577, Active, not recruiting, Mirati Therapeutics Inc. | Trial completion date: Dec 2024 --> Jun 2025
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • docetaxel • sitravatinib (MGCD516)
    8ms
    BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov)
    P3, N=430, Enrolling by invitation, BeiGene | N=300 --> 430
    Enrollment change
    |
    temozolomide • Lenvima (lenvatinib) • Tevimbra (tislelizumab-jsgr) • Fruzaqla (fruquintinib) • Partruvix (pamiparib) • Ziihera (zanidatamab-hrii) • Avzivi (bevacizumab-tnjn) • ociperlimab (BGB-A1217) • sitravatinib (MGCD516) • BGB-15025 • BGB-A445 • alcestobart (LBL-007) • surzebiclimab (BGB-A425)
    12ms
    SNAPI: Sitravatinib and Nivolumab for the Treatment of Metastatic or Advanced Clear Cell Renal Cell Cancer (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jan 2025 --> Jan 2027 | Trial primary completion date: Jan 2025 --> Jan 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    Opdivo (nivolumab) • sitravatinib (MGCD516)