Kite Pharma Presents Phase 1 Results From ZUMA-1 at the 57th American Society of Hematology (ASH) Annual Meeting
December 07 2015 - 10:00AM
Kite Pharma, Inc. (Nasdaq:KITE) today announced clinical results
and biomarker data for the phase 1 portion of Kite's ZUMA-1 trial
of KTE-C19 in patients with refractory, aggressive non-Hodgkin
lymphoma (NHL). KTE-C19 is an investigational therapy in which a
patient's T cells are genetically modified to express a chimeric
antigen receptor (CAR) designed to target the antigen CD19, a
protein expressed on the cell surface of B cell lymphomas and
leukemias.
David Chang, M.D., Ph.D., Kite Pharma's Executive Vice
President, Research and Development, and Chief Medical Officer,
commented, "We are encouraged by these early clinical findings from
our first company-sponsored, multi-center clinical trial in this
highly refractory patient population. The overall safety, efficacy,
and biomarker data were generally consistent with previously
published data from the National Cancer Institute (NCI) and
supported advancing ZUMA-1 to the pivotal phase. We look forward to
providing interim data from the pivotal phase 2 portion of the
study in 2016."
A summary of the ZUMA-1 Poster Presentations at ASH:
"Phase 1 Clinical Results of the ZUMA-1 (KTE-C19-101)
Study: A Phase 1-2 Multi-Center Study Evaluating the Safety and
Efficacy of Anti-CD19 CAR T Cells (KTE-C19) in Subjects with
Refractory Aggressive Non-Hodgkin Lymphoma (NHL)."
Abstract #3991; Presenter: Frederick Locke M.D., Moffitt Cancer
Center; Monday, December 7, 2015: 6:00-8:00pm Eastern.
- Phase 1 of the ZUMA-1 study treated a total of 7 patients with
refractory, aggressive diffuse large B cell lymphoma (DLBCL)
- KTE-C19 was administered at a target dose of 2 x 106 (minimum 1
x 106) anti-CD19 CAR T cells/kg body weight after a fixed-dose
conditioning chemotherapy regimen
- KTE-C19 was successfully manufactured for all leukapheresed
subjects
- KTE-C19 related adverse events consisted predominantly of
cytokine release syndrome (CRS) and neurotoxicity, which were
self-limited and generally reversible
- One subject experienced dose-limiting toxicities of grade 4
encephalopathy and CRS, and grade 5 intracranial hemorrhage. The
grade 5 event was deemed unrelated to KTE-C19 per the study
investigator
- Four complete remissions (CRs) and one partial remission (PR)
were observed, representing an overall objective response rate of
71% (5/7)
- All CRs were observed at one month
- Three subjects had ongoing CRs at three months.
"Phase 1 Biomarker Analysis of the ZUMA-1 (KTE-C19-101)
Study: A Phase 1-2 Multi-Center Study Evaluating the Safety and
Efficacy of Anti-CD19 CAR T Cells (KTE-C19) in Subjects with
Refractory Aggressive Non-Hodgkin Lymphoma (NHL)."
Abstract number #2730; Presenter: Sattva S. Neelapu, M.D., The
University of Texas MD Anderson Cancer Center; Sunday, December 6,
2015: 6:00-8:00pm Eastern.
- In vitro and in vivo characteristics of KTE-C19 from 7 subjects
in the Phase 1 portion of ZUMA-1 study were evaluated by flow
cytometry, co-culture, and a panel of cytokines, chemokines and
immune effector related markers
- KTE-C19 contains naïve and central memory T cells. CAR T cells
peaked within 2 weeks post infusion and were detectable at 1-3+
months post-infusion
- Select homeostatic, pro-inflammatory/regulatory cytokines,
tumor homing chemokines and effector molecules peaked within 1-2
weeks post-infusion and generally decreased within 3 weeks
- The overall product characteristics and pharmacodynamic profile
of KTE-C19 in ZUMA-1 phase 1 subjects were consistent with what has
been observed with anti-CD19 CAR T cell therapy in the ongoing NCI
study.
About Kite's ZUMA Clinical Programs
|
Study |
Phase |
Indication |
Status |
ZUMA-1
NCT02348216 |
Phase 2 Pivotal (N=112) |
Refractory DLBCL, PMBCL, TFL |
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 |
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.
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. 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 success and timing of ZUMA-1, including obtaining and
reporting results from the trial. 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, 2015. 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.
CONTACT: Kite Pharma
Cynthia M. Butitta
Chief Financial Officer and Chief Operating Officer
310-824-9999
For Media: Justin Jackson
For Investor Inquiries: Lisa Burns
Burns McClellan
212-213-0006
jjackson@burnsmc.com
lburns@burnsmc.com
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