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Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Epacadostat Shows Value in Two SCCHN Trials

    Cancer Discovery
    |August 2, 2017
    PubMed
    Summary

    Epacadostat combined with PD-1 inhibitors showed positive results in head and neck squamous cell carcinoma and other cancers. This combination therapy, including epacadostat plus pembrolizumab, offers a promising new treatment avenue.

    Area of Science:

    • Oncology
    • Immunotherapy
    • Cancer Research

    Background:

    • Indoleamine 2,3-dioxygenase 1 (IDO1) is an enzyme implicated in immune suppression.
    • IDO1 inhibitors are being investigated to enhance anti-tumor immune responses.
    • PD-1 checkpoint inhibitors have shown efficacy in various solid tumors.

    Purpose of the Study:

    • To evaluate the efficacy of epacadostat, an IDO1 inhibitor, in combination with PD-1 inhibitors.
    • To assess the safety and activity of this combination therapy in patients with advanced solid tumors.

    Main Methods:

    • Clinical trials (ECHO-202/KEYNOTE-037 and ECHO-204) involving patients with head and neck squamous cell carcinoma.
    • Combination therapy with epacadostat and PD-1 inhibitors (pembrolizumab or nivolumab).

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  • Evaluation of patient response in other solid tumors like melanoma, urothelial carcinoma, renal cell carcinoma, and non-small cell lung cancer.

    • Main Results:

    • Patients with head and neck squamous cell carcinoma demonstrated favorable responses to epacadostat plus pembrolizumab and epacadostat plus nivolumab.
    • Epacadostat in combination with PD-1 inhibitors showed promising activity across multiple solid tumor types.

    Conclusions:

    • The combination of epacadostat and PD-1 inhibitors is a promising therapeutic strategy for head and neck squamous cell carcinoma.
    • This combination approach warrants further investigation in other solid tumors due to observed promising activity.