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. IMPLICATIONS FOR PRACTICE: Cancer immunotherapy targeting immune checkpoint inhibitors (ICIs) has led to a paradigm shift in the treatment of various malignancies. However, data regarding the pharmacokinetic and pharmacodynamic profiles of ICIs in the Chinese population are lacking. Currently, there are 26 phase I studies actively investigating 14 ICIs in China. In this article, we outlined all the ongoing phase I studies of multinational corporation-developed ICIs and domestic-developed ICIs targeting the Chinese population, hoping to shed some light on the status quo of ICI research and developments in China.