Kite Pharma to Submit BLA for CAR-T Lymphoma Therapy, Using Phase II Data

Kite Pharma announced positive interim results from a Phase II clinical trial of its immunotherapy in patients with aggressive non-Hodgkin’s lymphomas, and said the study would form the basis of its marketing submissions to the FDA.

The trial met its primary endpoint, demonstrating an objective response rate of 79 percent, including about 52 percent complete remissions, in patients with diffuse large B-cell lymphoma, transformed follicular lymphoma, or primary mediastinal B-cell lymphoma.

Kite Pharma’s product — KTE-C19, known as a chimeric antigen receptor T-cell therapy, or CAR-T — involves genetically engineering samples of the patient’s own T-cells, which are then reintroduced into the bloodstream to target an immune response against certain lymphoma and leukemia cells.