National Hospital Organization Nagoya Medical Center, 4-1-1 San-No-Maru, Naka-Ku, Nagoya, Japan.
Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Cancer Immunol Immunother. 2023 Aug;72(8):2865-2871. doi: 10.1007/s00262-023-03432-4. Epub 2023 Apr 24.
We previously conducted a randomized phase II trial of OCV-501, a WT1 peptide presented by helper T cells, in elderly AML (acute myeloid leukemia) patients in first remission, indicating no difference in 2-year disease-free survival (DSF) between the OCV-501 and placebo groups. Here, we analyzed 5-year outcome and biomarkers. Five-year DFS was 36.0% in the OCV-501 group (N = 52) and 33.7% in the placebo group (N = 53), with no significant difference (p = 0.74). The peripheral WT1 mRNA levels were marginally suppressed in the OCV-501 group compared with the placebo group. Enhanced anti-OCV-501 IgG response by the 25th week was an independent favorable prognostic factor. Anti-OCV-501 IFNγ responses were less frequent than the IgG reactions. These findings suggest that host immunoreactivity has a significant impact on the prognosis of AML and that further improvement of the WT1 peptide vaccine is needed.
我们之前进行了一项随机的 OCV-501 二期临床试验，OCV-501 是一种由辅助性 T 细胞呈递的 WT1 肽，用于治疗首次缓解的老年 AML（急性髓系白血病）患者，结果表明，OCV-501 组和安慰剂组在 2 年无病生存率（DFS）方面没有差异。在这里，我们分析了 5 年的结果和生物标志物。OCV-501 组（N=52）的 5 年 DFS 为 36.0%，安慰剂组（N=53）为 33.7%，无显著差异（p=0.74）。与安慰剂组相比，OCV-501 组外周 WT1 mRNA 水平略有抑制。第 25 周时，对 OCV-501 的增强型抗 IgG 反应是一个独立的有利预后因素。抗 OCV-501 IFNγ 反应比 IgG 反应更少见。这些发现表明，宿主免疫反应对 AML 的预后有重大影响，需要进一步改进 WT1 肽疫苗。
