Rationale for once-daily or twice-daily dosing of zanubrutinib in patients with mantle cell lymphoma
| Autor: | Lucy Liu, Ying C. Ou, Srikumar Sahasranaman, William Novotny, Yuying Gao, Zhiyu Tang, Aileen Cohen, Kun Wang |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Phases of clinical research Lymphoma Mantle-Cell 03 medical and health sciences 0302 clinical medicine Piperidines Pharmacokinetics Internal medicine medicine Humans In patient Trough Concentration business.industry Hematology medicine.disease Pyrimidines 030220 oncology & carcinogenesis Pharmacodynamics Pyrazoles Mantle cell lymphoma Twice daily dosing Once daily business 030215 immunology |
| Zdroj: | Leukemia & Lymphoma. 62:2612-2624 |
| ISSN: | 1029-2403 1042-8194 |
| DOI: | 10.1080/10428194.2021.1929961 |
| Popis: | This report summarizes a totality-of-evidence approach supporting recommendation of a 320-mg total daily dose, either as 160-mg twice daily (BID) or 320-mg once daily (QD) for zanubrutinib in patients with mantle cell lymphoma. Data were derived from a phase 2 study in patients receiving 160-mg BID and a phase 1/2 study with similar response rates observed with 160-mg BID or 320-mg QD. Given the limited number of patients in the QD dose group, population pharmacokinetics and exposure-response analyses were employed to bridge the two regimens. The analyses showed that similar plasma exposure and BTK inhibition were achieved, and differences in trough concentration and maximum plasma concentration between the two regimens are unlikely to have a meaningful impact on efficacy and safety endpoints. The totality of data, including pharmacokinetic, pharmacodynamic, safety, efficacy, and exposure-response analyses, provided support for the recommended 320-mg total daily dose for the approved indication. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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