Lessons From the Development of the Immune Checkpoint Inhibitors in Oncology. Integr Cancer Ther 2018 Dec;17(4):1012-1015
Date
09/20/2018Pubmed ID
30229677Pubmed Central ID
PMC6247554DOI
10.1177/1534735418801524Scopus ID
2-s2.0-85065266106 (requires institutional sign-in at Scopus site) 4 CitationsAbstract
Immunotherapies are becoming increasingly important in the treatment armamentarium of a variety of malignancies. Immune checkpoint inhibitors are the most representative drugs receiving regulatory approval over the past few years. In a recent study published in Clinical Cancer Research, we demonstrated that these agents are being developed faster than other prior anticancer therapies. All checkpoint inhibitors received priority review, being granted with at least one Food and Drug Administration expedited program. Hence, some of them are getting marketing approval after preliminary trials. The model continues to rely on phase I trials, designed with traditional models for dose definition, although a substantial number of patients are treated during the dose expansion cohorts. We demonstrated that efficacy and safety are reasonably predicted from the dose-finding portion of phase I trials with these agents, assuring a low treatment-related mortality for patients throughout the development process. In this article, we further discuss and summarize these findings and update some recent approval information for immune checkpoint inhibitors.
Author List
Jardim DL, de Melo Gagliato D, Kurzrock RAuthor
Razelle Kurzrock MD Center Associate Director, Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Clinical Trials, Phase I as TopicHumans
Immunologic Factors
Immunotherapy
Medical Oncology
Neoplasms
United States
United States Food and Drug Administration