Exposure-safety and exposure-efficacy analyses for tisotumab vedotin for patients with locally advanced or metastatic solid tumors.
Autor: | Passey C; Genmab US, Inc., Princeton, New Jersey, USA., Voellinger J; Seagen Inc., Bothell, Washington, USA., Gibiansky L; QuantPharm LLC, North Potomac, Maryland, USA., Gunawan R; Seagen Inc., Bothell, Washington, USA., Nicacio L; Seagen Inc., Bothell, Washington, USA., Soumaoro I; Genmab US, Inc., Princeton, New Jersey, USA., Hanley WD; Seagen Inc., Bothell, Washington, USA., Winter H; Gilead Sciences, Inc., Foster City, California, USA., Gupta M; Genmab US, Inc., Princeton, New Jersey, USA. |
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Jazyk: | angličtina |
Zdroj: | CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 Sep; Vol. 12 (9), pp. 1262-1273. Date of Electronic Publication: 2023 Jul 26. |
DOI: | 10.1002/psp4.13007 |
Abstrakt: | The antibody-drug conjugate (ADC) tisotumab vedotin (TV) received accelerated approval from the US Food and Drug Administration for treatment of adults with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or after chemotherapy. A population pharmacokinetic (PK) model, developed using dosing data from four clinical TV studies, was used to estimate individual exposure and explore safety and efficacy exposure-response (ER) relationships. Because PK analysis showed no appreciable accumulation of TV and monomethyl auristatin E (MMAE) with repeated dosing, cycle 1 exposure metrics and predicted average concentrations from time zero until end of the cycle in which an event occurred (C (© 2023 Genmab US Inc. and Seagen, Inc. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.) |
Databáze: | MEDLINE |
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