Kite Pharma, Inc.
Jul 7, 2016

Kite Pharma Completes Enrollment of All Patients with Diffuse Large B-Cell Lymphoma (DLBCL) in Pivotal Multi-Center Phase 2 Study of KTE-C19 (ZUMA-1)

Interim Efficacy Results and BLA Filing Expected in 2016

SANTA MONICA, Calif.--(BUSINESS WIRE)-- 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.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and timing of obtaining interim KTE-C19 data and submitting a BLA with the U.S. Food and Drug Administration for regulatory approval based on the ZUMA-1 study of KTE-C19. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended March 31, 2016. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Kite Pharma
Greg Mann
VP, Investor Relations
gmann@kitepharma.com
or
For Media:
inVentiv Health
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Source: Kite Pharma, Inc.

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