Considerations on the alternative dosing regimens of anti-PD-1 or PD-L1 antibodies for treatment of patients with cancer based on pharmacokinetics
LIU Mei-xia
MA Jing-yi
LIU Shu-jie
LIU Shao-dan
HE Rui-rui
Abstract：In order to improve the compliance of patients and convenience of drug administration,a number of anti-PD-1/PD-L1 antibodies for cancer treatment have been developed during the development process or after the approval.More dosing regimens can be provided by varying the dosage and dosing intervals.Based on the relevant guidelines in China and abroad,the approved cases and the problems in the application process of alternative dosing regimens of anti-PD-1/PD-L1 antibodies for treatment of patients with cancer.This article analyzes the key focus points to support the alternative dosing regimen of anti-PD-1/PD-L1 antibody for tumor treatment based on pharmacokinetic methods,in order to provide references for the sponsors to explore the alternative dosing regimen of anti-PD-1/PD-L1 antibody for tumor treatment.
Keywords：anti-PD-1/PD-L1 antibodydosing regimenspopulation-PKdose/exposure-response
Publication Date：2024-11-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2228-2233 )