Key clinical point: Wilms’ tumor 1 helper peptide OCV-501 was well tolerated, but did not significantly improve clinical outcomes in elderly patients with acute myeloid leukemia (AML) in first complete remission (CR1). However, immune responders may benefit from OCV-501.
Major finding: The median disease-free survival ( P = .7671) and overall survival ( P = .8540) were not significantly different between OCV-501 vs. placebo groups. However, those with an immune response to OCV-501 had better survival outcomes ( P < .0001). Adverse drug reactions were more frequent in patients receiving OCV-501 vs. placebo (91.2% vs. 58.5%) and were mainly injection-site reactions.
Study details: This phase 2 study included 134 elderly (age ³60 years) patients with AML who achieved CR1 within 1 or 2 courses of standard induction therapies and were randomly assigned to either OCV-501 (n = 69) or placebo (n = 65).
Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd (OPCL). K Masui, Y Ihara, M Hirota, and N Shimofurutani reported being employees of OPCL. Some investigators, including the lead author, reported receiving grants and personal fees from various sources including OPCL.
Source: Kiguchi T et al. Cancer Immunol Immunother. 2021(Oct 22). Doi: 10.1007/s00262-021-03074-4.