Clinical development of immuno-oncology in China

Wu, Deng-Chyang; Huang, Hui; Tang, Yu; Zhao, Yang; Yang, Zhi; Wang, Jun; Wang, Shu Hang; Yu, Yue; Fang, Yuan; Fang, Hong; Bai, Ying; Sun, Chao; Fan, Qi; Yu, An; Wang, Huan Ling; Du, Chun Xia; Chen, Kun; Huang, Ming; Zhang, Yin; Li, Ning; Xu, Bing; Sun, Yi; He, Jie

doi:10.1016/s1470-2045(20)30329-6

Cited by 17 publications

(15 citation statements)

References 7 publications

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“…Actually, domestic enterprises were very active in the development of immune checkpoint inhibitors in China (25). Within 4 years, eight PD-1 and four PD-L1 medications were approved by NMPA.…”

Section: Discussionmentioning

confidence: 99%

Availability and Affordability of Oncology Drugs in 2012-2021 in China and the United States

Huang

Zhu²,

Ga³

et al. 2022

Front. Oncol.

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ObjectiveTo systematically summarize the landscape and characteristics of all approved new anticancer drugs for the last 10 years in China and the United States (US) to further inform the trend, current state, and existing gap in the availability and affordability of cancer medicine between the two countries.MethodsMainly based on the Pharmcube database, a list and detailed information of anticancer drugs approved in China and the United States were acquired. The annual number, time lag, and basic characteristics, including drug type, mechanism, enterprise type, indication population, drug target, and cancer type of approved drugs were compared.ResultsEighty-seven and 118 new anticancer drugs were approved in China and the US, respectively, showing a stable trend in the US, while a significant increase was observed after 2016 in China. Of the 42 cancer medicines launched in both countries, the US took precedence, and the median time lag markedly decreased, from 6.53 years in 2012 to 0.88 years in 2020. A total of 14.4% of drugs were applicable to children in the US, while only 2.3% were applicable in China, and there was no difference in drug type and enterprise. Thirty-one and 43 targets were explored, with respect to 27 and 36 cancer types in China and the US, respectively, during the period. In addition, the expenditure of drugs on PD-1 and PD-L1 in China was generally lower than that in America.ConclusionThe availability of new anticancer drugs has increased dramatically in the past decade, particularly in China. Compared with the US, the launch of new anticancer drugs in China lags behind, but the time lag has been shortened significantly, and better affordability is observed in immune drugs. More attention should be given to differentiated innovation, and unmet medical needs in special populations like childhood tumors, which are important directions of new drug R&D in China.

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Section: Discussionmentioning

confidence: 99%

Availability and Affordability of Oncology Drugs in 2012-2021 in China and the United States

Huang

Zhu²,

Ga³

et al. 2022

Front. Oncol.

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“…Similar concerns related to this duplication of immuno-oncology research in NSCLC have been raised by other researchers. 9 …”

Section: Discussionmentioning

confidence: 99%

Current Landscape of Immunotherapy Trials Involving the Programmed Cell Death Protein 1/Programmed Death-Ligand 1 Axis in Intrathoracic Tumors

Kareff

Samtani

Burotto³

et al. 2021

JTO Clinical and Research Reports

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Introduction The clinical successes seen with anti–programmed cell death protein 1/programmed death-ligand 1 (anti–PD-[L]1) agents have galvanized the field of immuno-oncology. We evaluated the landscape and trends in immunotherapy trials involving the PD-(L)1 axis in intrathoracic tumors. Methods We identified clinical trials involving anti–PD-(L)1 agents on the ClinicalTrials.gov registry through November 13, 2020 for NSCLC, SCLC, mesothelioma, and thymic epithelial tumor. Clinical trials were indexed according to monotherapy versus combination approaches, PD-(L)1 agents under investigation, clinical settings, trial start date, and partner drug(s). We assessed redundancy among the clinical trials. Results We found 686 clinical trials investigating anti–PD-(L)1 agents for intrathoracic tumors (540 trials in NSCLC, 96 in SCLC, 38 in mesothelioma, and 12 in thymic epithelial tumor). A total of 23 PD-(L)1 inhibitors are undergoing clinical development. A total of 81% of trials assess combination treatment. The number of clinical trials has been growing exponentially in the past decade. PD-(L)1 blockade was frequently combined with chemotherapy or immunomodulatory therapy. Various strategies are in development to overcome resistance to PD-(L)1 blockade in metastatic NSCLC. PD-(L)1 blockade is also increasingly evaluated in neoadjuvant and adjuvant settings. After the U.S. Food and Drug Administration’s approval of an anti–PD-(L)1 agent for a specific indication, 14 trials were launched thereafter, which continued to randomize patients to treatments that were inferior to the best available therapy. Conclusions The number of clinical trials investigating anti–PD-(L)1 agents in intrathoracic tumors has experienced a steep increase over the past decade with a notable upward trend for combination trials. To reduce duplicative research efforts and accelerate the development of effective immunotherapeutics, improved coordination among key stakeholders and the adoption of innovative trial designs will be vital.

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“…Anti-PD-1/PD-L1 treatment is now the standard of care for many cancer types worldwide [1,2]. Based on the feasibility of checkpoint blockade in the earlier stage of cancer [3][4][5][6], neoadjuvant and adjuvant immunotherapy has attracted more attention, especially neoadjuvant settings [3].…”

Section: To the Editormentioning

confidence: 99%

The global landscape of neoadjuvant and adjuvant anti-PD-1/PD-L1 clinical trials

Huang

Zhang

et al. 2022

J Hematol Oncol

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The neoadjuvant and adjuvant anti-PD-1/PD-L1 treatment has been increasingly noticed. To summarize the global landscape of these clinical trials will provide essential data for all the stakeholders of drug development. Based on the Trialtrove database, a total of 668 clinical trials initiated by the end of 2020 were retrospectively analyzed. We found that a rising capability of global neoadjuvant and adjuvant anti-PD-1/PD-L1 clinical development has been achieved. High prevalent cancer types were extensively studied though the priorities in China and the United States were different. However, a lack of phase III trials and industry-sponsored trials was addressed. The confirmatory neoadjuvant trials were particularly insufficient, and the combination strategy mainly focused on chemotherapy. Thus, more public funding and accelerated regulatory strategies are needed in this field. Efforts should be made to confirm the benefit of neoadjuvant treatment and explore novel combination strategies.

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Clinical development of immuno-oncology in China

Cited by 17 publications

References 7 publications

Availability and Affordability of Oncology Drugs in 2012-2021 in China and the United States

Availability and Affordability of Oncology Drugs in 2012-2021 in China and the United States

Current Landscape of Immunotherapy Trials Involving the Programmed Cell Death Protein 1/Programmed Death-Ligand 1 Axis in Intrathoracic Tumors

The global landscape of neoadjuvant and adjuvant anti-PD-1/PD-L1 clinical trials

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