Kite Pharma: 82% R/r ALL Patients In KTE-C19 Trials Achieve Complete Remission

(RTTNews) - Kite Pharma, Inc. (KITE), a clinical-stage biopharmaceutical company, announced late Sunday that, in a preliminary analysis of the Phase 1 ZUMA-3 and ZUMA-4 trials of KTE-C19, 82 percent of patients achieved complete remission or complete remission with incomplete or partial hematological recovery.

The trials of KTE-C19 were in adult and pediatric relapsed/refractory acute lymphoblastic leukemia or r/r ALL. In these patients, 100 percent of responders tested negative for minimal residual disease or MRD, which has been shown to correlate with risk of disease relapse in ALL.

Kite Pharma's lead product candidate, KTE-C19, is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor or CAR to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells.

The company presented the data at the American Society of Hematology or ASH Annual Meeting in San Diego, CA.

David Chang, Chief Medical Officer, said, "We are encouraged by the KTE-C19 safety and efficacy profile in ALL that is suggested by these data. In the Phase 1 portion of these studies, we are enrolling patients with high disease burden to rigorously evaluate safety and efficacy of KTE-C19. We look forward to initiating the Phase 2 portions of these studies in 2017."

KTE-C19 has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma by the U.S. Food and Drug Administration and Priority Medicines regulatory support for DLBCL in the EU.

Separately, Kite Pharma said it has initiated the rolling submission with the FDA of the Biologics License Application or BLA for KTE-C19 as a treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma or NHL who are ineligible for autologous stem cell transplant.

The company expects to complete its BLA submission by the end of the first quarter of 2017.