Kite Pharma’s (NASDAQ:KITE) use of prophylactic levetiracetam to control severe neurotoxicity associated with the chimeric antigen receptor T-cell (CAR-T) therapy KTE-C19 has valid rationale but uncertainties remain on its overall effectiveness.
Experts said their uncertainty stemmed from the lack of complete understanding of what is behind the neurological toxicities – including seizures – that have been common with CAR-T therapies. However, in the absence of that understanding, it makes sense to try the anti-seizure approach, they said.
This news service reported 30 September that the protocol for Kite's Phase I/II ZUMA-1 study of KTE-C19 in aggressive non-Hodgkin’s lymphoma (NHL) was mandating prophylactic use of levetiracetam to control seizures. The company subsequently announced plans to administer prophylactic levetiracetam at 750mg daily at its 18 October investor day to investigate its potential to mitigate neurotoxicity, several analyst reports noted.
Competing NHL studies of Juno Therapeutics’ (NASDAQ:JUNO) Phase I JCAR017 (NCT02631044) and Novartis’ (VTX:NOVN) Phase II tisagenlecleucel-T (NCT02445248) do not carry such mandates.