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Four hundred people with a brain tumour that had come back were randomly given either a virus-delivered enzyme plus a pill it converts into chemotherapy, or standard treatment; survival was the same.
Randomised, open-label phase 2/3 trial at 58 centres in the United States, Canada, Israel and South Korea. 403 patients having resection for a first or second recurrence of glioblastoma or anaplastic astrocytoma were randomised 1:1 to vocimagene amiretrorepvec, a retroviral replicating vector injected into the resection cavity wall, followed by cycles of oral flucytosine starting six weeks after surgery, or to investigator's choice of lomustine, temozolomide or bevacizumab.
Median overall survival was 11.10 months with the virus and prodrug and 12.22 months with standard of care, hazard ratio 1.06 (95% CI 0.83 to 1.35), p = 0.62. No secondary endpoint showed a significant difference. Adverse event rates were similar.
The design was the best case for the approach: the virus is injected under direct vision into the cavity where the tumour was, the prodrug converts to fluorouracil only where the virus has spread, and the trial was properly randomised and adequately sized. It still failed.
The clearest randomised refutation in the field. Phase 1 data had looked encouraging, the delivery problem was solved by surgical access, and the killing mechanism was a well-understood chemotherapy released in place. None of it translated. Any claim that oncolytic virotherapy works in glioma has to be read against this trial.
Shares Oncolytic viruses, Glioma & glioblastoma.
Shares Oncolytic viruses, Glioma & glioblastoma.
Shares Oncolytic viruses, Glioma & glioblastoma.
Shares Oncolytic viruses, Glioma & glioblastoma.
Shares Oncolytic viruses, Glioma & glioblastoma.
Shares Oncolytic viruses, Glioma & glioblastoma.
Shares Oncolytic viruses, Glioma & glioblastoma.