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Kite files first CAR-T candidate in Europe

But will need to play catch up in the US, where Novartis has a slight lead

Kite PharmaKite Pharma has claimed the prize of filing the first chimeric antigen receptor T cell (CAR-T) therapy in Europe, seeking approval of its axicabtagene ciloleucel (KTE-C19) for two types of non-Hodgkin's lymphoma (NHL).

The application keeps Kite's nose in front of Novartis in the EU, as the big pharma company has not yet submitted its application for its leukaemia CAR-T therapy tisagenlecleucel-T (CTL019) with the EMA.

Kite has filed axicabtagene ciloleucel in the EU as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for autologous stem cell transplant.

Novartis is thought to have a slim edge in the US market, with Kite eyeing an FDA verdict by November 29 and Novartis - which hasn't revealed a review date - estimated to be looking at a possible approval in September. Novartis has filed tisagenlecleucel-T for relapsed and refractory B-cell acute lymphoblastic leukemia (ALL) in the US - clearing an FDA advisory panel earlier this month - and the firm says it is planning to file for DLBCL later this year.

Both therapies are a new approach to immuno-oncology that use modified versions of a patient's own white blood cells to attack cancer. If approved, the highly-personalised therapy could offer new hope to patients with hard-to-treat cancers, with trials suggesting they can keep them in remission for months or even years. That could translate to sales worth several billion dollars per year, according to analysts.

They do have side effects however, as infusing large numbers of white cells into a patient can push the immune system into a high gear, with some patients in trials developing cytokine-release syndrome (CRS), which can be fatal if not managed but has also been seen with antibody therapies such as Roche's MabThera (rituximab).

Side effects have already claimed one pipeline casualty, with Juno Therapeutics giving up on its lead candidate JCAR015 earlier this year after patient deaths in trials.

Axicabtagene ciloleucel has been granted an accelerated assessment by the EMA under its PRIME (priority medicines) initiative, and Kite chief executive Arie Belldegrun said the EU filing "marks an important global milestone in the development of engineered T cell therapy".

The application is supported by data from the ZUMA-1 trial, which saw 82% of patients achieving a response with the CAR-T after a single infusion. At a median follow-up of 8.7 months, 44% of patients were in ongoing response, including 39% who had complete responses.

Article by
Phil Taylor

1st August 2017

From: Regulatory

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