Gilead Subsidiary Kite Submits BLA for Second CAR-T Therapy KTE-X19 to Treat Relapsed/Refractory Mantle Cell Lymphoma

On December 11, Kite, a Gilead company, announced the submission of a Biologics License Application (BLA) to the FDA for its CAR-T therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). If approved, it would become the first CAR-T therapy for the treatment of relapsed or refractory MCL.

Mantle Cell Lymphoma: A Rare Non-Hodgkin Lymphoma Characterized by High Aggressiveness and Poor Prognosis, Primarily Affecting Elderly Men Over 60 Years of Age. Clinical Manifestations Include Lymphadenopathy, Hepatosplenomegaly, and Bone Marrow Involvement; More Than 80% of Patients Are Diagnosed at an Advanced Stage, Underscoring the Urgent Need for Novel Innovative Therapies.

KTE-X19 is a CD19-targeted CAR-T cell therapy that has received Breakthrough Therapy designation from the FDA. In this Phase II clinical study, codenamed ZUMA-2, enrolled patients had received multiple prior therapies, including chemotherapy, anti-CD20 monoclonal antibodies, and the BTK inhibitors ibrutinib or acalabrutinib, but experienced disease relapse or developed resistance.

Results from the Phase II ZUMA-2 clinical study showed that patients treated with KTE-X19 achieved an overall response rate (ORR) of 93%, including a complete response (CR) rate of 67%. At a median follow-up of 12.3 months, 57% of patients maintained their response. Among the initial cohort of 28 treated patients, 43% remained alive and in continued remission without receiving additional therapy, with a median follow-up of 24 months for this subgroup. The estimated 12-month progression-free survival (PFS) and overall survival (OS) rates were 61% and 83%, respectively. Median duration of response (DoR), PFS, and OS had not been reached.

Regarding safety, the incidence rates of grade 3 or higher cytokine release syndrome (CRS) and neurological events were 15% and 31%, respectively, with no occurrences of grade 5 CRS or neurological events.