Abstract 3186
Background
A 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.
Methods
Based 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.
Results
There 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.Table:
1293P The landscape of immuno-oncology targets in clinical development in China since 2013
Types | Targets | Agents N = 62 (%) | Trials N = 230 (%) | |||
---|---|---|---|---|---|---|
Total | Phase I | Phase II/III | Approv ed | |||
T-cell targeted immuno- modulator | PD-1 | 17 (27.4) | 6 | 7 | 4 | 129 (56.1) |
PD-L1 | 12 (19.4) | 5 | 7 | 51 (22.2) | ||
CTLA-4 | 3 (4.8) | 1 | 2 | 11 (4.8) | ||
IDO1/TDO | 2 | 2 | 2 | |||
IDO1 | 1 | 1 | 1 | |||
CD137 | 1 | 1 | 1 | |||
LAG3 | 1 | 1 | 1 | |||
OX40 | 1 | 1 | 1 | |||
PD-1/CTLA-4 | 1 | 1 | 1 | |||
PD-L1/CTLA-4 | 1 | 1 | 1 | |||
PD-L1/ TGF-βRII | 1 | 1 | 1 | |||
Other immuno- modulator | Unspecified | 1 | 1 | 5 (2.2) | ||
CD47 | 1 | 1 | 1 | |||
MUC1 | 1 | 1 | 1 | |||
Cancer vaccine | TLR | 2 | 2 | 2 | ||
EGF | 1 | 1 | 1 | |||
MUC1 | 1 | 1 | 1 | |||
Cell Therapy | Unspecified | 4 (6.5) | 2 | 2 | 4 (1.7) | |
CD19 | 3 (4.8) | 3 | 3 (1.3) | |||
BCMA | 1 | 1 | 1 | |||
Oncolytic virus | GM-CSFR | 4 (6.5) | 1 | 3 | 9 (3.9) | |
CD3-targeted bispecific mAb | CD19 | 1 | 1 | 1 | ||
HER2 | 1 | 1 | 1 |
Conclusions
Though 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.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3290 - Identification of meningioma patients in high risk of tumor recurrence using microRNA profiling
Presenter: Josef Srovnal
Session: Poster Display session 3
Resources:
Abstract
2477 - Antecedent of cancer and mortality after the first ST segment elevation acute myocardial infarction treated with primary coronary angioplasty. A prospective cohort study
Presenter: Irene Sillero
Session: Poster Display session 3
Resources:
Abstract
1894 - Genomic characterisation of locally advanced pancreatic adenocarcinoma
Presenter: Sarah Picardo
Session: Poster Display session 3
Resources:
Abstract
3280 - Comparison of freshly prepared and frozen cells from colorectal cancer surgical samples for phenotyping experiments- a pilot study
Presenter: Sandra Mersakova
Session: Poster Display session 3
Resources:
Abstract
3419 - Hyaluronan (HA) Accumulation in the Tumor Microenvironment (TME) is Increased in Colorectal Cancer (CRC) and Associated with Consensus Molecular Subtypes (CMS) 4 Molecular Subtype
Presenter: Barbara Blouw
Session: Poster Display session 3
Resources:
Abstract
1833 - Evaluation of CT-based radiomics in patients with renal cell carcinoma
Presenter: An Zhao
Session: Poster Display session 3
Resources:
Abstract
5883 - Detection of Double Protein Expression in Diffuse Large B Cell Lymphoma
Presenter: Mohamed Gouda
Session: Poster Display session 3
Resources:
Abstract
5415 - Encyclopedic Tumor Analysis for organ agnostic treatment with Axitinib in combination regimens for advanced cancers
Presenter: Tim Crook
Session: Poster Display session 3
Resources:
Abstract
3297 - Computational model to predict response rate of clinical trials
Presenter: Orsolya Lorincz
Session: Poster Display session 3
Resources:
Abstract
4355 - Analysis of BRCA genes and homologous recombination deficiency (HRD) scores in tumours from patients (pts) with metastatic breast cancer (mBC) in the OlympiAD trial
Presenter: Mark Robson
Session: Poster Display session 3
Resources:
Abstract