Ongoing Phase I Studies of Immune Checkpoint Inhibitors in China

Abstract

Abstract Background Cancer immunotherapy targeting immune checkpoint inhibitors (ICIs) has been shown to be a promising strategy in the treatment of various malignancies. Despite the proven efficacy and tolerability of ICIs based on 113 clinical trials globally, data regarding the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of ICIs in the Chinese population are lacking. As of June 1, 2018, not a single ICI has been approved by the China Food and Drug Administration. Materials and Methods Currently, there are 26 ongoing phase I studies actively investigating the safety, antitumor activity, and PK/PD profiles of six multinational corporation (MNC)-developed ICIs and eight domestic-developed ICIs in the Chinese population. Data regarding study designs, treatment interventions, targeted populations, and the current states of these studies were collected and summarized. Results We outlined 8 phase I studies assessing MNC-developed ICIs and 18 phase I studies assessing domestic-developed ICIs in the Chinese population in this article, in order to provide researchers with a clear picture of the status quo of ICI research and developments in China. Conclusion Immuno-oncology in China remains at a preliminary stage. Despite the substantial amount of phase I studies of ICIs, early-phase studies with designs incorporating characteristics of Chinese patients are still lacking.