Efficacy and safety of Wilms’ tumor 1 helper peptide OCV-501 in elderly patients with acute myeloid leukemia: a multicenter, randomized, double-blind, placebo-controlled phase 2 trial

Kiguchi, Toru; Takezako, Naoki; Miyawaki, Shuichi; Masui, Koichi; Ihara, Yuichiro; Hirota, Michio; Shimofurutani, Naoko; Naoe, Tomoki

doi:10.1007/s00262-021-03074-4

Cited by 5 publications

(3 citation statements)

References 41 publications

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“…The utility of the WT1 peptide vaccine in elderly patients was examined in a placebo-controlled Phase II study of the WT1 helper peptide (OCV-501) vaccine in AML-CR patients ( n = 134). 38 Although no significant difference was observed in the relapse rate or mDFS, a significant prolongation of OS was observed in patients who responded immunologically to OCV-501. This indicates that the effectiveness of the WT1 peptide vaccine in elderly patients may be limited.…”

Section: Wt1 Vaccine For Hematological Malignanciesmentioning

confidence: 87%

Wilms’ tumor 1 -targeting cancer vaccine: Recent advancements and future perspectives

Ogasawara

2023

Human Vaccines & Immunotherapeutics

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This mini-review explores recent advancements in cancer vaccines that target Wilms’ tumor (WT1). Phase I/II trials of WT1 peptide vaccines have demonstrated their safety and efficacy against various cancers. Early trials employing HLA class I peptides evolved through their combination with HLA class II peptides, resulting in improved clinical outcomes. Additionally, WT1-targeted dendritic cell vaccines have exhibited favorable results. Studies focusing on hematological malignancies have revealed promising outcomes, including long-term remission and extended survival times. The combination of vaccines with immune checkpoint inhibitors has shown synergistic effects. Current preclinical developments are focused on enhancing the effectiveness of WT1 vaccines, underscoring the necessity for future large-scale Phase III trials to further elucidate their efficacy.

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Section: Wt1 Vaccine For Hematological Malignanciesmentioning

confidence: 87%

Wilms’ tumor 1 -targeting cancer vaccine: Recent advancements and future perspectives

Ogasawara

2023

Human Vaccines & Immunotherapeutics

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“…Among the 58 surviving patients, updated information was obtained from 52 patients and censored data at the end of the trial were used in the remaining 6 patients. The study procedure and assessment were described previously [ 11 ].…”

Section: Methodsmentioning

confidence: 99%

“…Previous studies revealed that OCV-501 induces not only peptide-specific Th1 cells but also WT1-specific cytotoxic T-lymphocytes, suggesting its potential as a cancer vaccine [ 9 ]. From 2013 to 2017, a "multicenter, randomized, placebo-controlled, double-blind, comparative study (Phase II) to evaluate the efficacy and safety of OCV-501 in elderly patients with AML" (referred to as “OCV-501 Phase II trial”) was conducted [ 11 ]. Patients with AML aged 60 years or older who had achieved their first complete remission (CR) were randomized to receive OCV-501 (N = 69) or placebo (N = 65), administered the vaccine, and observed for 2 years.…”

Section: Introductionmentioning

confidence: 99%

Immunoreactivity to WT1 peptide vaccine is associated with prognosis in elderly patients with acute myeloid leukemia: follow-up study of randomized phase II trial of OCV-501, an HLA class II-binding WT1 polypeptide

Naoe

Saito

Hosono

et al. 2023

Cancer Immunol Immunother

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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.

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Peptide Antigen‐Surfaced TLR9‐Adjuvanting Nanovaccines as a Versatile Therapeutic Modality to Eradicate Acute Myeloid Leukemia

Sun,

Cui,

Shi

et al. 2024

Adv Funct Materials

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Peptide antigen vaccines constitute a promising clinical strategy for treating cancer patients. However, their anticancer immune response remains modest because of the suboptimal presentation of peptide antigens and/or insufficient activation of antigen‐presenting cells (APCs). The development of therapeutic vaccines for acute myeloid leukemia (AML) poses an even greater challenge because AML cells disseminate throughout the body. In this study, the peptide antigen‐surfaced TLR9‐adjuvanting nanovaccines (PASTA‐NV), which display multiple Wilm's tumor 1 (WT1) peptides on their surface and encapsulate CpG ODN adjuvants within their watery interior to simultaneously increase antigen presentation and APC activation/proliferation, are reported. Interestingly, systemic administration of PASTA‐NV induces strong cellular and humoral anticancer immune responses in orthotopic murine AML MLL‐AF9 models. When combined with an anti‐CTLA4 antibody, PASTA‐NV achieves complete regression of AML in mouse models and establishes durable anti‐AML immunity, effectively resisting rechallenge with leukemic cells. PASTA‐NV provides a new and general avenue to induce robust and specific anticancer immunity, which has the potential to revive peptide antigen‐based nanovaccines for tumor therapy.

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Efficacy and safety of Wilms’ tumor 1 helper peptide OCV-501 in elderly patients with acute myeloid leukemia: a multicenter, randomized, double-blind, placebo-controlled phase 2 trial

Cited by 5 publications

References 41 publications

Wilms’ tumor 1 -targeting cancer vaccine: Recent advancements and future perspectives

Wilms’ tumor 1 -targeting cancer vaccine: Recent advancements and future perspectives

Immunoreactivity to WT1 peptide vaccine is associated with prognosis in elderly patients with acute myeloid leukemia: follow-up study of randomized phase II trial of OCV-501, an HLA class II-binding WT1 polypeptide

Peptide Antigen‐Surfaced TLR9‐Adjuvanting Nanovaccines as a Versatile Therapeutic Modality to Eradicate Acute Myeloid Leukemia

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