Author: Vishnevskaya Karina
Copy editor: Kigbayeva Kamila
Gilberto Lopes (Cancer Center at the University of Miami, Florida, USA) said:
“The approval of the new pembrolizumab dosing regimen is very timely, as we are trying to reduce the frequency of visits and contacts within the cancer centers to help control the COVID-19 pandemic and protect our vulnerable patients. This regimen, of course, allows stable patients to visit cancer centers every six weeks, and not every three weeks.”
In the course of this study, data were obtained that the minimum and maximum concentrations for the 6-week dosing regimen are comparable with the concentration of pembrolizumab in the 200 mg regimen every 3 weeks, as well as with the dose-dependent distribution in the regimen where the dose of the drug was calculated based on the patient’s weight (modes with Pembrolizumab 2 mg / kg every 3 weeks and 10 mg / kg every 2 weeks). The FDA's positive decision is based on pharmacokinetic modeling and a dose-dependent analysis comparing the predicted concentrations of pembrolizumab 400 mg with pembrolizumab at 2 mg / kg every 3 weeks, 200 mg every 3 weeks and 10 mg / kg every 2 weeks. The results of pharmacokinetic modeling were confirmed by the data of the international multicenter open-label study KEYNOTE-555, in which 101 patients with inoperable or metastatic melanoma who had not previously received PD-1, PD-L1 or CTLA-4 inhibitors took part. The results of KEYNOTE-555 (Cohort B) were presented at the American Cancer Research Association (AACR). The primary point of this study was the frequency of an objective response, secondary points included pharmacokinetic exposure, as well as progression-free survival (PFS) and safety.
Source: https://rosoncoweb.ru/news/oncology/
