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. 2022 Feb 8;15(1):16.
doi: 10.1186/s13045-022-01227-1.

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

Dawei Wu #  1 , Huiyao Huang #  1 , Minghui Zhang #  2 , Ziwei Li  1   3 , Shuhang Wang  1 , Yue Yu  1 , Yuan Fang  1 , Ning Jiang  1 , Huilei Miao  1 , Peiwen Ma  1 , Yu Tang  1 , Ning Li  4
Affiliations

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

Dawei Wu et al. J Hematol Oncol. .

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.

Keywords: Adjuvant; Anti-PD-1/PD-L1 treatment; Clinical trial; Neoadjuvant.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Annual numbers of initiated neoadjuvant and adjuvant anti-PD-1/PD-L1 trials worldwide, overall and by study phase. The compound annual growth rates of overall, phase I, phase II and phase III trials were 73.6%, 44.6%, 91.9% and 71.0%, respectively
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References

    1. Yu JX, Hodge JP, Oliva C, Neftelinov ST, Hubbard-Lucey VM, Tang J. Trends in clinical development for PD-1/PD-L1 inhibitors. Nat Rev Drug Discov. 2020;19(3):163–164. doi: 10.1038/d41573-019-00182-w. - DOI - PubMed
    1. Wu DW, Huang HY, Tang Y, et al. Clinical development of immuno-oncology in China. Lancet Oncol. 2020;21(8):1013–1016. doi: 10.1016/S1470-2045(20)30329-6. - DOI - PubMed
    1. O'Donnell JS, Hoefsmit EP, Smyth MJ, Blank CU, Teng MWL. The promise of neoadjuvant immunotherapy and surgery for cancer treatment. Clin Cancer Res. 2019;25(19):5743–5751. doi: 10.1158/1078-0432.CCR-18-2641. - DOI - PubMed
    1. Keung EZ, Ukponmwan EU, Cogdill AP, Wargo JA. The rationale and emerging use of neoadjuvant immune checkpoint blockade for solid malignancies. Ann Surg Oncol. 2018;25(7):1814–1827. doi: 10.1245/s10434-018-6379-8. - DOI - PMC - PubMed
    1. Topalian SL, Taube JM, Pardoll DM. Neoadjuvant checkpoint blockade for cancer immunotherapy. Science. 2020;367(6477):eaax082. doi: 10.1126/science.aax0182. - DOI - PMC - PubMed

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