The clinical development of tumor immunotherapy in China in the past 20 years presents these three major trends

Over the past decade, the emergence of immuno-checkpoint inhibitors and CAR-T cell therapy has revolutionized the standard of treatment for many types of cancer and marked a new era of modern immunotherapy for oncology.
recently, the Chinese Academy of Medical Sciences Cancer Hospital, the National Cancer Center team in the "The Lancet?" The Lancet Oncology, a paper, reviews the development of clinical trials of oncology immunotherapy in China over the past 20 years.
The study, based on China's state-owned database, the Chinadrugtrials, included 365 cancer immunoscance trials registered between 2010 and 2019, involving 103 immunotherapies under development.
70% annual growth rate of the number of trials, data show that from 2010 to 2019, the number of immunotherapy trials launched in China increased each year, with an average annual growth rate of 70%.
, the number of clinical trials initiated in 2016 increased by 363 percent compared to 2015.
According to the research phase, there were 148 clinical trials (41%), 79 (22%), 137 (38%), and 1 trial phase unknown.
number of new immunotherapy treatments registered each year has also increased significantly over time, with an average annual growth rate of 49 per cent.
data also show that China's biopharmaceutical industry has made great progress since 2015.
II, the research and development pipeline high setChinese chapter pointed out that in China, the research and development pipeline of tumor immunotherapy is highly concentrated, that is, focused on very few targets and treatment categories, while new targets and new cell therapies are few.
this, the researchers divided these treatments by treatment category according to the action process, and gave the target of each drug candidate and the latest stage of research and development.
data show that 103 treatments in the study corresponded to 34 different targets, of which PD-1 and PD-L1 were the most widely studied targets, with 23 (22%) and 14 (14%) respectively.
followed by CD19 and CTLA-4, with 8 and 7 respectively.
57 (55%) of the 103 immunotherapies studied were immunomodulants targeting T-cells, 16 were cell therapies and 15 were other immunomodulants.
article points out that a highly concentrated pipeline of research and development is related to the new drug development model of china's local biopharmaceutical companies - giving priority to products similar to clinically proven compounds for development can avoid the risk of drug development failure to a certain extent.
addition, the development of dual-specific antibodies in China has been welcomed.
, most of these new targeted immunotherapies are in early stages of development, and indicators of adverse reactions and efficacy prediction have yet to be explored, the researchers said.
, the authors say the balance between improving the efficiency of innovative drug research and development and reducing risk deserves the attention of pharmaceutical companies and policymakers.
, PD-1/L1 therapy research and development under the mainstream of thinking at present, China has been developed by local companies innovative PD-1 antibodies approved for market.
in clinical trials, the number of anti-PD-1/L1 therapies in China has increased at an average annual rate of 152%.
article mentions that China's State Drug Administration (NMPA) issued in 2018 the Basic Data Requirements for the Declaration and Listing of Anti-PD-1/PD-L1 Monoantigens to Standardize Clinical Trials and Speed Up the Approval Process.
as of December 2019, there were 279 clinical trials for PD-1/L1 products, accounting for 76% of all cancer immunoscence trials.
, 127 were monodr drug clinical trials (46%) and 152 were combined drug studies (54%).
, the proportion of single-drug trials fell by 30 per cent a year, while the proportion of co-drug studies rose by 34 per cent a year.
can be seen that over time, clinical development strategies for anti-PD-1/L1 therapy have under changed significantly from monodring to combination drugs.
, the researchers note that many of the same joint strategies have been observed in the data.
, for example, 87 (57%) chemotherapy, 57 (38%) targeted therapy, and 27 (18%) immunotherapy were included in 152 joint trials.
the same time, there have been many studies involving more than two treatments (25, 16%).
, they stressed that greater emphasis should be placed on new strategies with a strong scientific basis, and that joint drug use rationale and risk assessment were necessary.
also analyzed cancer types and treatment options for target populations in anti-PD-1/L1 therapy trials.
data show that, in contrast to the overall distribution of cancer types in drug trials (with a low percentage of trials), China has conducted a large number of trials of anti-PD-1/L1 therapy for local high-risk cancers, including 279 hepatocellular carcinoma trials (29%), 18 esophageal cancer trials and 15 stomach cancer trials.
will help to identify promising treatment options for these unsealed clinical needs.
it is worth noting that for approved adaptations to anti-PD-1/L1 therapies, there are still many trials of the same adaptations under study, such as non-small cell lung cancer and recurring or refractive lymphoma.
other anti-PD-1/L1 therapies have been approved for adaptation, such as Merkel cell carcinoma, kidney cancer, mesothelioma, endometrial cancer and other clinical trials are few.
addition, the article also mentioned that the combination of new ancillary, auxiliary or maintenance treatment with surgery, chemotherapy is worth exploring.
can be seen that for the development of anti-PD-1/L1 therapies, new drug combination strategies, patient population to improve the quality of trials, provide high-level evidence, and future product expansion of adaptive disorders have an important impact.
article affirms the importance of such products in meeting clinical needs and suggests differentiated development strategies.
, clinical trials of cancer immunotherapy in China have developed significantly over the past five years.
however, the article notes that we still need to work on new targets, cell therapies for market licensing, new joint strategies, and target patient populations for anti-PD-1/L1 therapy trials.
believe that local biopharmaceutical companies in China are ready to make breakthroughs in immuno-oncology treatment, which will help develop and meet the needs of cancer patients around the world.
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