Kite Pharma to Present Interim Results from the ZUMA-1 Pivotal Trial of KTE-C19 in a Late-Breaking Session at the 2016 Americ...
November 21 2016 - 9:19AM
Business Wire
- 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
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 Information
Session Name: Late-Breaking Abstracts SessionSession Date:
Tuesday, December 6, 2016Session Time: 7:30 AM - 9:00 AM
PTPresentation Time: 8:45 AM PTRoom: 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
About KTE-C19
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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version on businesswire.com: http://www.businesswire.com/news/home/20161121005641/en/
Kite PharmaChristine CassianoSVP, Corporate Communications &
Investor Relationsccassiano@kitepharma.comorGreg MannVP, Investor
Relationsgmann@kitepharma.com
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