Rather like Kite’s (NASDAQ:KITE) registrational Zuma-1 trial of KTE-C19 in lymphoma, Novartis’ (NYSE:NVS) Eliana study has generated a fileable response rate. In the case of the Swiss firm’s rival CAR-T therapy, CTL019, this is in childhood leukemia patients.
While safety has likely taken on fresh importance with the US FDA, Novartis confirmed that CTL019 would be submitted early next year, putting it neck and neck with Kite to bring the first CAR product to market. But perhaps underappreciated is Eliana’s demonstration that a complex autologous cell therapy has real-world potential, with one commercial site manufacturing product for three continents.
The University of Pennsylvania’s Dr Stephan Grupp, who presented the interim Eliana readout at Ash on Saturday, said the trial was the first of a CAR-T product to be truly global. It took in 25 hospitals at sites in North America, Europe and the Asia/Pacific region.
