Abstract
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.
References
Mar 5, 2005·The New England Journal of Medicine·Elizabeth HorstmannChristine Grady
Mar 5, 2005·The New England Journal of Medicine·Razelle Kurzrock, Robert S Benjamin
Jan 12, 2010·The Oncologist·Jeff SummersRichard Pazdur
Jul 27, 2012·Human Vaccines & Immunotherapeutics·Thomas A GardnerNoah M Hahn
Aug 21, 2012·Cancer Management and Research·Brendon J Coventry, Martin L Ashdown
Jun 19, 2013·Annals of the New York Academy of Sciences·Jedd D WolchokAlan J Korman
Nov 6, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Denis L JardimDavid S Hong
Jan 22, 2015·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Michael A PostowJedd D Wolchok
Jul 16, 2016·Oncotarget·Denis Leonardo JardimRazelle Kurzrock
Sep 21, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jonathan Kimmelman
Nov 9, 2016·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Stéphane ChampiatCharles Ferté
Nov 25, 2016·Cancer Treatment Reviews·Denis L JardimRazelle Kurzrock
Mar 30, 2017·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Shumei KatoRazelle Kurzrock
Dec 8, 2017·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Denis L JardimRazelle Kurzrock
Jan 11, 2018·The New England Journal of Medicine·Michael A PostowMatthew D Hellmann
Mar 22, 2018·The New England Journal of Medicine·Robert J MotzerUNKNOWN CheckMate 214 Investigators
Apr 12, 2018·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Daniel ShepshelovichEitan Amir
May 8, 2018·Cancer Treatment Reviews·Julien TaiebYung-Jue Bang