Intratumoral oncolytic herpes virus G47∆ for residual or recurrent glioblastoma: a phase 2 trial

Abstract This investigator-initiated, phase 2, single-arm trial primarily assessed the efficacy of G47∆, a triple-mutated, third-generation oncolytic herpes simplex virus type 1, in 19 adult patients with residual or recurrent, supratentorial glioblastoma after radiation therapy and temozolomide (UMIN-CTR Clinical Trial Registry UMIN000015995). G47Δ was administered intratumorally and repeatedly for up to six doses. The primary endpoint of 1-yr survival rate after G47∆ initiation was 84.2% (95% confidence interval, 60.4–96.6; 16 of 19). The prespecified endpoint was met and the trial was terminated early. Regarding secondary endpoints, the median overall survival was 20.2 (16.8–23.6) months after G47∆…

• JA
  Japan Agency for Medical Research and Development

  Awards: JP18ck0106416, JP15ck0106144, JP20lm0203140
• KU
  Kanazawa University
• UO
  University of Tokyo
• SM
  Saitama Medical University
• IO
  Institute of Medical Science, University of Tokyo