Abstract
BackgroundA bran-new landscape of immuno-oncology (IO) is arising in China rapidly, with IO development a hotspot in biopharmaceutical industries. Moreover, a paucity of data on the panorama of IO clinical trials in China inspired us to present the systemic analysis for stakeholders in this field. MethodsBased on the Platform for Registry and Publicity of Drug Clinical Trials, a national authoritative database by China Food and Drug Administration, the trials for IO agents issued from 2013 to 2018 were explored using newly developed agents (by six types of mechanism and targets) and the number of initiated trials as key indicators. The clinical development stages of all agents were presented by targets. In addition, time trends in annually initiated trials and cumulative indication distribution were investigated. ResultsThere were 62 IO agents and 230 initiated trials in China from 2013 to 2018, with 46 (74.2%) agents and 154 (67.0%) trials from domestic firms. The 62 agents modulated 18 targets focusing on PD-1 (17, 27.4%), PD-L1 (12, 19.4%) and unspecified tumor-associated antigens (5, 8.1%). Only 8 agents of cell therapy were ever developed for registration purpose. PD-1/L1 targets were most extensively investigated with a total of 180 (78.3%) trials and 4 agents approved. The annual number of trials showed an upward trend, and the sharp increase for trials of T-cell targeted immuno-modulators was seen with an average growth rate of 199.1% since 2016. In terms of cancer types, solid tumor (56, 24.3%), non-small cell lung cancer (45, 19.6%) and hepatocellular cancer (20, 8.7%) were the most common. Only 14 (6.1%) trials applied a biomarker enrichment strategy.Table1293P The landscape of immuno-oncology targets in clinical development in China since 2013TableTypesTargetsAgents N=62 (%)Trials N=230 (%)TotalPhase IPhase II/IIIApprov edT-cell targeted immuno- modulatorPD-117 (27.4)674129 (56.1)PD-L112 (19.4)5751 (22.2)CTLA-43 (4.8)1211 (4.8)IDO1/TDO222IDO1111CD137111LAG3111OX40111PD-1/CTLA-4111PD-L1/CTLA-4111PD-L1/ TGF-βRII111Other immuno- modulatorUnspecified115 (2.2)CD47111MUC1111Cancer vaccineTLR222EGF111MUC1111Cell TherapyUnspecified4 (6.5)224 (1.7)CD193 (4.8)33 (1.3)BCMA111Oncolytic virusGM-CSFR4 (6.5)139 (3.9)CD3-targeted bispecific mAbCD19111HER2111 ConclusionsThough a gap exists in the number of agents and targets between China and the global pipeline, the rising capability of IO has been achieved in China recently. Efforts should be further made in novel targets, cell therapy for registration purpose, Chinese unique cancers and new trial designs. Legal entity responsible for the studyNational Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.
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