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The global landscape of neoadjuvant and adjuvant anti-PD-1/PD-L1 clinical trials
Dawei Wu1, Huiyao Huang1, Minghui Zhang2
1Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Abstract:
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.
Insights
Global clinical trials for neoadjuvant and adjuvant anti-PD-1/PD-L1 cancer treatments are increasing. However, there
Area of Science:
- Oncology
- Clinical Trials
- Immunotherapy
Background:
- Analysis of 668 global clinical trials initiated by end of 2020 for neoadjuvant and adjuvant anti-PD-1/PD-L1 therapies.
- Identified a growing global capacity in developing these immunotherapies for cancer treatment.
Discussion:
- Cancer type priorities differ between China and the United States.
- Shortage of Phase III trials and industry-sponsored studies noted.
- Insufficient confirmatory trials for neoadjuvant treatments and limited combination strategies, primarily with chemotherapy.
Key Insights:
- Significant increase in neoadjuvant and adjuvant anti-PD-1/PD-L1 clinical development globally.
- High prevalence cancer types are well-represented, but regional differences exist.
- Gaps identified in late-stage trials and novel combination strategies.
Outlook:
- Need for increased public funding and expedited regulatory pathways.
- Focus required on confirming neoadjuvant treatment benefits.
- Exploration of novel combination strategies beyond chemotherapy is essential.
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