KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell therapy that uses the XLP manufacturing process
Image: FDA centre for drug evaluation and research. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
Kite, a subsidiary of Gilead, has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for its KTE-X19, intended for relapsed mantle cell lymphoma (MCL) in adults.
KTE-X19 is an investigational, autologous, anti-CD19 chimeric antigen receptor (CAR) T cell therapy, which uses the XLP manufacturing process, including T-cell selection and lymphocyte enrichment.
Kite said that the investigational drug KTE-X19 is currently subject to the Phase 1/2 trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
Kite clinical development global head Ken Takeshita said: “There remains a significant need for new treatments for patients with relapsed/refractory MCL despite recent advances, so this regulatory filing is an especially important milestone for the MCL community.
“We look forward to working with the FDA to bring KTE-X19 to appropriate patients as quickly as possible and continuing to deliver on the promise of our industry-leading cell therapy development program with a second CAR T therapy.”
KTE-X19 demonstrated positive results in Phase 2 ZUMA-2 clinical study
The company said that the BLA submission is supported by the data from Phase 2 ZUMA-2 trial, which showed 93% overall response rate, including 67% complete response.
In the study, the response was evaluated by an Independent Radiologic Review Committee (IRRC), after a single infusion of KTE-X19.
The safety analysis has found Grade 3 or higher cytokine release syndrome (CRS) in 15% and neurologic events in 31% of patients. No Grade 5 CRS or neurologic events are reported.
Kite said that its KTE-X19 has secured the FDA Breakthrough Therapy Designation and the European Medicines Agency (EMA) Priority Medicines (PRIME) approval.
Also, it intends to submit a marketing authorisation application for KTE-X19 in the European Union (EU) in early 2020.
The biopharmaceutical company is specialised in chimeric antigen receptor and T cell receptor engineered cell therapies, and develops advanced cancer immunotherapies.