November 21, 2016
Kite Pharma to Present Interim Results from the ZUMA-1 Pivotal Trial of KTE-C19 in a Late-Breaking Session at the 2016 American Society of Hematology Annual Meeting
- KTE-C19 Significantly Improved Objective Response Rate in Patients with Chemorefractory DLBCL at Pre-Defined Interim Analysis
- Represents One of Only Six Abstracts Accepted as a Late-Breaking Presentation
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite Pharma, Inc. (Nasdaq:KITE) today announced that data from the interim analysis of the pivotal ZUMA-1 trial of KTE-C19 in patients with chemorefractory aggressive non-Hodgkin lymphoma (NHL) have been accepted as an oral late-breaking presentation at the American Society of Hematology (ASH) 58th Annual Meeting in San Diego, CA, on December 6, 2016. The abstract was one of only six accepted in this category and will be included in the December 1 online issue of Blood.
"Outcomes for patients with aggressive NHL depend on whether their disease is sensitive to chemotherapy. The ZUMA-1 study was designed to support registration of KTE-C19 by enrolling a well-defined chemorefractory patient population," said Jeff Wiezorek, M.D., Senior Vice President of Clinical Development of Kite. "We are pleased with the outcome of the study to date and thank the patients and investigators for their participation in the first positive pivotal study in CAR-T therapy."
The abstract, titled "KTE-C19 (anti-CD19 CAR T Cells) Induces Complete Remissions in Patients with Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Results from the Pivotal Phase 2 ZUMA-1," will be presented by Sattva S. Neelapu, M.D., Associate Professor at the University of Texas MD Anderson Cancer Center, Houston, TX.
Session Name: Late-Breaking Abstracts Session
Session Date: Tuesday, December 6, 2016
Session Time: 7:30 AM - 9:00 AM PT
Presentation Time: 8:45 AM PT
Room: San Diego Convention Center, Hall AB
This oral presentation will feature interim results from the ZUMA-1 Phase 2 trial. In September 2016, Kite announced ZUMA-1 positive interim topline results (objective response rate 79 percent; complete remission rate 52 percent) from 62 patients with 3 months of follow-up in both Cohort 1 and Cohort 2. Cohort 1 included patients with DLBCL, and Cohort 2 enrolled patients with transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL). Details of data available at the time of interim analysis, including 93 patients who had the opportunity to be followed for one month, will be presented in the late-breaker presentation on December 6, 2016. Cohort 2 data will be covered in a separate oral presentation on December 5, 2016: Abstract #998, A Phase 2 Multicenter Trial of KTE-C19 (anti-CD19 CAR T Cells) in Patients with Chemorefractory Primary Mediastinal B-Cell Lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL): Interim Results From ZUMA-1, https://ash.confex.com/ash/2016/webprogram/Paper94812.html
Kite Pharma's lead product candidate, KTE-C19, is an investigational therapy in which a patient's T cells are engineered to express a 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. KTE-C19 has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
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.
Cautionary Note on 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. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "expected," "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 intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to obtain regulatory approval based on the ZUMA-1 trial 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 September 30, 2016. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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VP, Investor Relations
Source: Kite Pharma, Inc.
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