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
5383 - A pilot trial to investigate the impact of a personalised self-management lifestyle programme using mobile technology on the health and wellbeing of cancer survivors
Presenter: Mary Grace Kelly
Session: Poster Display session 3
Resources:
Abstract
5084 - The BRIGHTLIGHT national survey of the impact of specialist teenage and young adult cancer care on caregivers’ information and support needs
Presenter: Rachel Taylor
Session: Poster Display session 3
Resources:
Abstract
4328 - Life beyond cancer: Occupational health care service support in returning work experienced by cancer survivals
Presenter: Minna Nurmi
Session: Poster Display session 3
Resources:
Abstract
3337 - Investigating the factors related to primary caregivers' burden in oncology patients in Greece
Presenter: Ourania Govina
Session: Poster Display session 3
Resources:
Abstract
3387 - Factors Influencing the Level of Emotional Support from Nurses Perceived by Patients Undergoing Haematopoietic Stem Cell Transplantation in Protective Isolation
Presenter: Michela Piredda
Session: Poster Display session 3
Resources:
Abstract
935 - Progressive Muscle Relaxation and Guided Imagery Techniques and the Way of Coping of Parents of Children with Malignancies: A randomized controlled trial
Presenter: Tsitsi Theologia
Session: Poster Display session 3
Resources:
Abstract
3457 - Pharmacist and Nurse Led Melanoma Immunotherapy Clinic
Presenter: Dharmisha Chauhan
Session: Poster Display session 3
Resources:
Abstract
5160 - Measuring the impact of the Irish Cancer Society's Cancer Information Services
Presenter: Aileen McHale
Session: Poster Display session 3
Resources:
Abstract
4297 - It's Great to Talk
Presenter: Noreen Andersen
Session: Poster Display session 3
Resources:
Abstract
4444 - Impact of Burn-Out Syndrome in Oncology personnel and its improvement through specific interventions
Presenter: Inmaculada Ortega
Session: Poster Display session 3
Resources:
Abstract