Levetiracetam (Keppra) + standard of care, single-arm phase 2

A pilot study of levetiracetam as a sensitizer of temozolomide for newly diagnosed glioblastoma: A prospective, open-label, phase II study (KBTS-1601 study).
https://meetinglibrary.asco.org/record/189964/abstract

This was reported at the recent ASCO virtual conference.

• Eligible patients were aged 18 years or older and had newly diagnosed glioblastoma with an ECOG performance status of 0-2
• The first dose of levetiracetam was given just after the surgery at 250mg orally twice a day and increased up to 500mg twice a day prior to radiation
• Forty-six patients were enrolled between August 2016 and January 2019
• Median overall survival (OS) was 30.0 months, and median PFS was 15.0 months

This was a single arm trial, with outcomes compared to a historical control group. A median overall survival of 30 months and median progression-free survival of 15 months does seem to be an improvement on historical results. 

For comparison, the unblinded results of the phase 3 DCVax trial (preliminary report based on 331 patients) had a median overall survival of 23.1 months from surgery. The historical control group used by the Korean team that conducted this levetiracetam trial had median OS of 17.5 months.