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    DRUG:

    FS118

    i
    Other names: FS118, FS-118
    Company:
    Sino Biopharm
    Drug class:
    PD-L1 inhibitor, LAG-3 inhibitor
    Related drugs:
    10ms
    A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=95, Active, not recruiting, invoX Pharma Limited | Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Jun 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    LAG3 (Lymphocyte Activating 3)
    |
    paclitaxel • FS118
    over1year
    A Phase 1 first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1 in patients with advanced cancer and PD-L1 resistance. (PubMed, Clin Cancer Res)
    FS118 was well tolerated with no DLTs observed up to and including 20 mg/kg QW. Further studies are warranted to determine clinical benefit in patients who have become refractory to anti-PD-(L)1 therapy.
    P1 data • Journal
    |
    LAG3 (Lymphocyte Activating 3)
    |
    FS118
    over1year
    Durable response of anaplastic thyroid carcinoma to FS118, a bispecific LAG-3/PD-L1 antibody, after checkpoint inhibitor progression: a case report. (PubMed, J Immunother Cancer)
    Simultaneously, expanded use should be considered for those with refractory disease, especially if PD-L1 positive. Insights Dual PD-L1/LAG-3 blockade may be an effective treatment strategy for refractory metastatic tumors, including anaplastic thyroid cancer.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • BRAF V600E • BRAF V600 • PD-L1 mutation
    |
    FS118
    over3years
    FS118 First in Human Study in Patients With Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=80, Recruiting, F-star Delta Limited | Active, not recruiting --> Recruiting | Phase classification: P1 --> P1/2 | N=43 --> 80 | Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2022
    Clinical • Enrollment open • Phase classification • Enrollment change • Trial completion date • Trial primary completion date
    |
    LAG3 (Lymphocyte Activating 3)
    |
    FS118
    over3years
    [VIRTUAL] A first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1, in patients with advanced cancer and resistance to PD-(L)1 therapy (SITC 2020)
    Conclusions Weekly treatment with FS118 was well tolerated up to 20 mg/kg and was associated with pharmacodynamic markers of FS118 activity. Encouraging signs of clinical activity were observed in highly pre-treated patients who had acquired resistance to prior PD-(L)1 therapy.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • LAG3 expression
    |
    FS118
    over3years
    [VIRTUAL] A first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1, in patients with advanced cancer and resistance to PD-(L)1 therapy (SITC 2020)
    Conclusions Weekly treatment with FS118 was well tolerated up to 20 mg/kg and was associated with pharmacodynamic markers of FS118 activity. Encouraging signs of clinical activity were observed in highly pre-treated patients who had acquired resistance to prior PD-(L)1 therapy.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • LAG3 expression
    |
    FS118