Kite Pharma Initiates Phase 1b/2 Combination Study for KTE-C19 & Atezolizumab in Patients with Refractory Diffuse Large B-cel...
October 06 2016 - 8:30AM
Business Wire
First patient enrolled in ZUMA-6 study
evaluating safety and efficacy of anti-CD19 CAR (KTE-C19) therapy
in combination with anti-PD-L1 monoclonal antibody atezolizumab
Kite Pharma, Inc. (Nasdaq:KITE) today announced the first
patient was enrolled in ZUMA-6, a Phase 1b/2 clinical study of
KTE-C19 in combination with atezolizumab, Genentech’s anti-PD-L1
cancer immunotherapy. The trial is designed to evaluate the safety
and efficacy of the combination in patients with refractory diffuse
large B-cell lymphoma (DLBCL).
PD-L1 expression in DLBCL is associated with high-risk disease
and poor outcomes. The interaction of PD-L1 and PD-1, which is
expressed on KTE-C19, may dampen T-cell activity in some patients.
As a result, use of the two compounds in combination could provide
a synergistic effect since inhibiting PD-L1 with atezolizumab may
enhance and prolong the activity and proliferation of KTE-C19.
“The ZUMA-6 combination study is a core element of our broad
strategy to optimize KTE-C19 treatment outcomes and to
significantly extend the important potential benefits of KTE-C19
monotherapy,” said David Chang, M.D., Ph.D., Kite's Executive Vice
President, Research and Development, and Chief Medical Officer. “We
view the scientific rationale for this combination study as
compelling and look forward to advancing the study based on our
extensive clinical experience.”
Kite entered a clinical collaboration in March 2016 with
Genentech, a member of the Roche Group, to evaluate the safety and
efficacy of KTE-C19 in combination with atezolizumab. The first
ZUMA-6 patient was enrolled at the end of September 2016.
About ZUMA-6
ZUMA-6 is the first industry-sponsored clinical trial to enroll
patients to study the combination of an anti-CD19 engineered
chimeric antigen receptor (CAR) T-cell and a checkpoint inhibitor.
The study will proceed as a single-arm, open-label, multi-center
study in patients with chemotherapy-refractory DLBCL. The Phase 1b
portion of ZUMA-6 will assess the safety of KTE-C19 and
atezolizumab given in sequence. The primary objective of the Phase
2 portion is to evaluate the combination’s safety and efficacy. The
study also includes secondary analyses of key biomarkers of T-cell
activity and other safety and efficacy endpoints. Kite will be the
sponsor of the study, and the results will be used to evaluate
options for further development of the combination. Additional
information about the ZUMA-6 study will be available at
www.clinicaltrials.gov by searching on NCT 02926833.
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 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.
Kite Pharma, Inc. 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,"
"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 advance the Phase 1b/2
combination study and expectations regarding the clinical
effectiveness and safety of the combination therapy. 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 June 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/20161006005320/en/
Kite Pharma, Inc.Christine CassianoSVP, Corporate Communications
& Investor Relationsccassiano@kitepharma.comorGreg MannVP,
Investor Relationsgmann@kitepharma.com
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