The European Medicines Agency (EMA) has begun its review of Gilead subsidiary Kite’s next-generation CAR-T therapy KTE-X19.
Kite is seeking approval for the CAR-T therapy for the treatment of adult patients with replapsed or refractory mantle cell lymphoma (MCL) – according to the company, if KTE-X19 is approved it will become the first CAR-T for this indication.
The marketing application was supported by data from the phase 2 ZUMA-2 trial, which demonstrated an overall response rate in the patient population of 93%, including 67% with complete response.
“Relapse rates in mantle cell lymphoma remain overwhelmingly high and there is a significant need for new therapies that may improve patients’ prognosis,” said Ken Takeshita, Kite’s global head of clinical development.
“The EMA validation of our marketing application brings us closer to delivering on the promise of our industry-leading cell therapy development program, with the hope that we can bring KTE-X19 to appropriate patients in Europe as quickly as possible,” he added.
Gilead/Kite already have one approved CAR-T therapy in the arsenal – Yescarta (axicabtagene ciloleucel) – which is approved for diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma.
Current treatment options for MCL include AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) and Johnson & Johnson/AbbVie’s BTK inhibitor Imbruvica (ibrutinib).
CAR-T therapies work differently to these drugs – in CAR-T therapies, patients’ cells are harvested and modified so they are more likely to seek out and destroy cancer cells expressing a particular antigen. Once reprogrammed, the T cells are infused back into the patient in order to fight the cancer.
The first CAR-T therapy to be approved was Novartis’ Kymriah back in August 2017, with Yescarta following a few months later, gaining approval in October.
Uptake of CAR-T therapies can prove difficult, as companies face significant challenges in manufacturing these treatments, a process which requires patients’ own T cells to be extracted and genetically modified, and eventually re-infused back into the patient.
Both Kymriah and Yescarta are available on for use on the NHS in England, with the health service quickly recommending these treatments – which NHS England chief executive Simon Stevens hauled as “revolutionary”.
Kite also submitted a biologics license application for KTE-X19 to the US Food and Drug Administration (FDA) on 11 December for the same indication.