Biologics License Application Submitted for Mantle Cell Lymphoma CAR T-Therapy KTE-X19

A Biologics License Application (BLA) has been submitted to the FDA for the investigational CAR T-cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)resistant to prior therapies, according to the agent’s developer, Kite.¹

The submission is based on data from the phase II ZUMA-II trial, which demonstrated that 93% of the study participants responded to the autologous anti-CD19 CAR T-cell therapy, with 67% of participants achieving a complete response.²

“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,” Ken Takeshite, MD, global head of clinical development for Kite, said in a press release. 

Findings from the trial were presented on December 9, 2019 at the 61^st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida.

In the safety analysis, grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15% and 31% of patients, respectively. No grade 5 CRS or neurologic events occurred.

The most commonly reported treatment-related adverse events (AEs) included pyrexia (94%), neutropenia (87%), thrombocytopenia (74%), anemia (68%), and hypertension (51%). Two grade 5 AEs were seen – one case of pneumonia related to conditioning chemotherapy, and one case of staphylococcal bacteremia related to the CAR T-cell infusion.

Kite plans to submit a Marketing Authorization Application for KTE-X19 in the European Union in early 2020, according to the developer. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the European Medicines Agency (EMA) for relapsed or refractory MCL.

KTE-X19 is still investigational and not currently approved anywhere globally. Its efficacy and safety have not been established. The CAR T-cell therapy is currently in phase I/II trials in acute lymphoblastic leukemia (ALL), MCL, and chronic lymphocytic leukemia (CLL).

References:

1. Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy [news release]. Santa Monica, California. Published December 11, 2019. investors.gilead.com/news-releases/news-release-details/kite-submits-biologics-license-application-us-food-and-drug. Accessed December 13, 2019.

2. KTE-X19: A CAR T-Cell Option for Mantle Cell Lymphoma? [news release]. Orlando Florida. Published December 10, 2019. ashclinicalnews.org/on-location/ash-annual-meeting/kte-x19-car-t-cell-option-mantle-cell-lymphoma/. Accessed December 11, 2019.