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
1802 - Evaluation of the anti-tumor efficacy and immune effects of N-809, a novel IL-15 superagonist/anti-PD-L1 bispecific agent
Presenter: Kristin Hicks
Session: Poster Display session 3
Resources:
Abstract
3190 - GI101, a novel triple-targeting bispecific CD80-IgG4-IL2variant fusion protein, elicits synergistic anti-tumor effects in preclinical models
Presenter: Jae Chan Park
Session: Poster Display session 3
Resources:
Abstract
4062 - Phase 1b, open-label, dose-escalation study of M9241 (NHS-IL12) plus avelumab in patients (pts) with advanced solid tumors
Presenter: Julius Strauss
Session: Poster Display session 3
Resources:
Abstract
5777 - THOR-707, a novel not-alpha IL-2, promotes all key immune system anti-tumoral actions of IL-2 without eliciting vascular leak syndrome (VLS)
Presenter: Marcos Milla
Session: Poster Display session 3
Resources:
Abstract
5047 - A phase I clinical trial of malignant pleural mesothelioma treated with locally delivered autologous anti-FAP-targeted CAR T-cells
Presenter: Alessandra Curioni
Session: Poster Display session 3
Resources:
Abstract
1679 - HPV16 E6-specific TCR-T armored with checkpoint blockade in the treatment of cervical cancer
Presenter: Paul Bryson
Session: Poster Display session 3
Resources:
Abstract
1133 - the Mutant Neoantigen Specific T Cell Is a Personalized Immunotherapy in Refractory Solid Tumor
Presenter: Qi Song
Session: Poster Display session 3
Resources:
Abstract
3338 - NY-ESO-1 and LAGE1A –an emerging target for cell therapies in solid tumours
Presenter: Ioanna Eleftheriadou
Session: Poster Display session 3
Resources:
Abstract
3089 - Targeting myeloid-derived suppressor cells and T cells: combination treatment with MTL-CEBPA and PD-1 antibody in a mouse syngeneic CT26 model
Presenter: Mikael Sodergren
Session: Poster Display session 3
Resources:
Abstract
5991 - Master Checkpoint Cbl-b Inhibition: Anti-tumor Efficacy in a Murine Colorectal Cancer Model Following siRNA-based Cell Therapy
Presenter: Kathrin Thell
Session: Poster Display session 3
Resources:
Abstract