Kite's CAR-T Therapy KTE-X19 Receives FDA Priority Review for Relapsed or Refractory Mantle Cell Lymphoma

Today, Kite, a Gilead Sciences company, announced that the U.S. FDA has accepted its Biologics License Application (BLA) for the CAR-T therapy KTE-X19 for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL). The FDA has also granted Priority Review designation to this therapy, with a decision expected by August 10 of this year. The press release noted that if approved, Kite would become the first company to have multiple commercialized CAR-T therapies.

Mantle Cell Lymphoma (MCL) is a rare type of non-Hodgkin lymphoma that arises from the malignant transformation of cells in the mantle zone of lymph nodes, typically affecting men over the age of 60. Although various therapies are currently available for this cancer type, patients eventually develop resistance to existing treatments, necessitating innovative therapeutic options.

KTE-X19 is an autologous CAR-T therapy targeting CD19. It utilizes the XLP manufacturing process, which incorporates T-cell selection and lymphocyte enrichment. For certain B-cell malignancies with evidence of circulating lymphoblasts, lymphocyte enrichment is a critical step in CAR-T therapy manufacturing. Currently, KTE-X19 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and mantle cell lymphoma (MCL). KTE-X19 has previously received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and PRIME medicine designation from the European Medicines Agency (EMA).

▲R&D Plan and Progress of KTE-X19 (Image source: Kite official website)

This BLA submission is based on positive data from the Phase 2 clinical trial named ZUMA-2. The MCL patients enrolled in this trial had previously received five prior lines of therapy, including chemotherapy, anti-CD20 monoclonal antibody therapy, and BTK inhibitors (ibrutinib or acalabrutinib), but had developed resistance or experienced disease relapse. The trial results demonstrated that among 60 MCL patients evaluable for efficacy, the overall response rate (ORR) was 93%, with 67% achieving complete response (CR). At a median follow-up time of 12.3 months, 57% of patients maintained their response. Among the initial 28 treated patients (with at least 24 months of follow-up), 43% remained alive and in sustained remission without requiring additional treatment.

References:

[1] U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma, Retrieved February 10, 2020, from https://www.businesswire.com/news/home/20200210005203/en/U.S.-FDA-Grants-Priority-Review-Kite’s-KTE-X19

[2] Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy, Retrieved February 10, 2020, from https://www.businesswire.com/news/home/20191211005861/en/Kite-Submits-Biologics-License-Application-U.S.-Food

Note: The original text has been abridged.

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