Interim Efficacy Results and BLA Filing Expected in 2016
SANTA MONICA, CA, USA I July 7, 2016 I Kite Pharma, Inc. (Nasdaq: KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous cell therapy (eACT™) products for the treatment of cancer, announced today that it has completed enrollment of 72 patients in DLBCL cohort in the Phase 2 portion of ZUMA-1. KTE-C19 is an investigational therapy in which a patient’s T-cells are genetically modified to express a chimeric antigen receptor (CAR) that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.
The DLBCL cohort of ZUMA-1 enrolled patients whose disease is chemorefractory (no response to last line of therapy or has relapsed within 12 month of autologous stem cell therapy). Patients received a lymphodepletion regimen that consisted of “low-dose” chemotherapy regimen of cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) daily for 3 days prior to infusion of the target KTE-C19 dose of 2 x 106 cells/kg.
“We are excited to complete enrollment in our first multi-center KTE-C19 study, an important milestone toward bringing this potential breakthrough therapy to patients with an urgent need for better treatment,” said David Chang, M.D., Ph.D., Kite’s Executive Vice President, Research and Development, and Chief Medical Officer. “We are grateful to the patients and investigators who participated in our study. We look forward to announcing top-line data from the first 50 DLBCL patients in the ZUMA-1 study, and, subject to these results, plan on submitting our Biologics License Application (BLA) with the U.S. Food and Drug Administration by the end of 2016.”
About Kite’s ZUMA Clinical Programs for KTE-C19
KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.
| Study | Phase | Indication | Status |
| ZUMA-1 NCT02348216 |
Phase 2 Pivotal (N=112) | Chemorefractory DLBCL (N=72) PMBCL, TFL (N=40) | Phase 2 enrollment complete Phase 2 enrolling |
| ZUMA-2 NCT02601313 |
Phase 2 Pivotal (N=70) |
Relapsed/refractory MCL | Phase 2 enrolling |
| ZUMA-3 NCT02614066 |
Phase 1/2 Pivotal (N=75) |
Relapsed/refractory Adult ALL | Phase 1/2 enrolling |
| ZUMA-4 NCT02625480 | Phase 1/2 Pivotal (N=75) |
Relapsed/refractory Pediatric ALL | Phase 1/2 enrolling |
| DLBCL = diffuse large B-cell lymphoma | |||
| PMBCL = primary mediastinal B-cell lymphoma | |||
| TFL = transformed follicular lymphoma | |||
| MCL = mantle cell lymphoma | |||
| ALL = acute lymphoblastic leukemia | |||
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system’s ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
SOURCE: Kite Pharma
