Kite Pharma Provides Update on KTE-C19 Clinical Trial

Kite Pharma has provided an update from its ongoing Phase I/II clinical trial of KTE-C19 in patients with refractory aggressive non-Hodgkin's lymphoma (NHL) who have failed prior chemotherapy treatments and have a poor prognosis. KTE-C19 is an investigational therapy in which a patient's T cells are genetically modified to express a Chimeric Antigen Receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

In May, Kite announced that the first patient was treated with KTE-C19 in the Phase I portion of the trial and we have since treated multiple patients. Complete responses have been observed by investigators. The responses happened shortly after treatment was administered and Kite is monitoring these patients to determine durability of treatment. To date, toxicities associated with treatment have been similar to those observed in the National Cancer Institute's study of anti-CD19 CAR T cell therapy. There was one patient death early in the study, which was determined to be unrelated to KTE-C19 by the study investigator. After appropriate discussions with FDA, Kite continued to enroll and treat patients in its study and the study was never placed on clinical hold. Kite has submitted an abstract and plans to present top-line data from the Phase I portion of the trial at the upcoming 2015 American Society of Hematology (ASH) Annual Meeting, to take place in Orlando, FL, 5–8 December 2015.

"We are encouraged by the progress of the KTE-C19 clinical trial and excited by the responses we have seen so far. We believe the KTE-C19 clinical findings are in line with previous results demonstrating the potential of this promising therapeutic approach," said Arie Belldegrun, Chairman, President and CEO of Kite. "In agreement with ASH, we have taken this exceptional step of providing an update on the trial to address recent misinformation in the market related to our clinical program. We are on track to transition to the Phase II portion of the trial and plan to present Phase I data at ASH later this year."

Kite's Phase I/II clinical trial of KTE-C19 is a single arm, open-label, multi-center study, designed to determine the safety and efficacy of KTE-C19 in patients with refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL). Upon completion of the Phase I portion of the study, Kite expects to proceed with the Phase II portion that will include a total of approximately 112 patients. Additional information about Kite's Phase I/II study may be found at ClinicalTrials.gov, using Identifier NCT: 02348216.