Kite Pharma has treated its first European patient with axicabtagene ciloleucel (KTE-C19 or axi-cel), its CAR-T therapy for B-cell lymphomas.
The start of the trial comes after Kite has already filed for approval of axi-cel in the EU based on the results of its ZUMA-1 trial of the therapy, which was conducted in the US. The first European patients are being treated with the CAR-T as part of a safety expansion cohort from that study.
ZUMA-1 trial showed that in a heavily-treated population with refractory aggressive non-Hodgkin’s lymphoma (NHL) – with few treatment options – axi-cel achieved an overall response rate of 82%, with 44% of patients still responding, including 39% in complete response (CR) after a median follow-up of 8.7 months.
The use of axi-cel in Europe “signifies an important step in making this ground-breaking and potentially curative therapy available … to patients suffering from NHL who have no other therapeutic options [and] previously faced a dismal outlook”, said Kite in a statement.
CAR-T is a new approach to immuno-oncology that uses modified versions of a patient’s own white blood cells to attack cancer, and has shown dramatic results in trials, but also side effects such as cytokine-release syndrome, which can sometimes follow the infusion of large numbers of white blood cells. The new EU safety cohort will support the ZUMA-1 trial in Kite’s EU application.
Kite is currently enrolling adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL) at multiple EU medical centres, with the first patient undergoing treatment at the Academic Medical Center (AMC) in Amsterdam, the Netherlands.
Axi-cel has been granted an accelerated assessment by the EMA under its PRIME (priority medicines) initiative, which supports the development and speeds up the review of new therapies for areas of high unmet medical need.
In Europe Kite has a slight lead over its main rival in the race to bring the first CAR-T therapy to market – Novartis with its tisagenlecleucel-T (CTL019) for relapsed and refractory B-cell acute lymphoblastic leukemia (ALL), although the latter has the edge in the US having cleared an FDA advisory committee vote.
Kite has described the market opportunity for its CAR-T as “highly compelling”, with an estimated 7,000 patients apiece eligible for treatment in the US and EU.
The company hired Chris Nowers – formerly head of immuno-oncology and haematology at Bristol-Myers Squibb (BMS) in France, as head of Europe to spearhead the roll-out of the therapy in the region.