Study Met Primary Endpoint of Objective
Response Rate (p<0.0001) at Interim Analysis
First Multicenter Pivotal Trial of CAR-T
Therapy to Report Positive Outcome
Company Plans to Present Additional Data at
Upcoming Scientific Meeting
Kite Pharma, Inc., (Nasdaq:KITE) today announced positive
topline results from a pre-planned interim analysis of ZUMA-1 for
its lead product candidate, KTE-C19, in patients with
chemorefractory diffuse large B-cell lymphoma (DLBCL). KTE-C19 met
the primary endpoint of objective response rate (ORR), p<0.0001,
with ORR of 76 percent, including 47 percent complete remissions
(CR).
ZUMA-1 enrolled patients with chemorefractory aggressive NHL
into two cohorts. Cohort 1 included patients with DLBCL, and Cohort
2 enrolled patients with transformed follicular lymphoma (TFL) and
primary mediastinal B-cell lymphoma (PMBCL). Kite’s intent is to
seek regulatory approval of KTE-C19 in DLBCL, TFL and PMBCL based
upon the combined data of both cohorts.
The interim analysis of ZUMA-1 evaluated the ORR in the first 51
patients in Cohort 1 with at least three months of follow-up. This
analysis also included an additional 11 patients in Cohort 2. The
table below summarizes the response rates from this interim
analysis together with the previously reported results from the
Phase 1 portion of ZUMA-1 (Neelapu ASCO 2016).
ZUMA-1 Phase 1 ZUMA-1 Phase 2
DLBCL (n=7)
DLBCL (n=51) TFL/PMBCL (n=11) Combined (n=62)
ORR
(%)
CR
(%)
ORR
(%)
CR
(%)
ORR
(%)
CR
(%)
ORR
(%)
CR
(%)
ORR 71 57 76 47 91 73
79 52 Month 3 43 43 39 33
64 64 44 39 Months 6 and
9 43 43 Data Pending
Across the combined 62 patients, the most common grade 3 or
higher adverse events included neutropenia (66 percent), anemia (40
percent), febrile neutropenia (29 percent), thrombocytopenia (29
percent), and encephalopathy (26 percent). Grade 3 or higher
cytokine release syndrome (CRS) and neurological toxicity was
observed in 18 percent and 34 percent of patients, respectively.
Two patients died from KTE-C19 related adverse events
(hemophagocytic lymphohistiocytosis and cardiac arrest in the
setting of CRS).
The Phase 2 interim outcomes in ZUMA-1 are largely consistent
with results from the Phase 1 portion of the study and the National
Cancer Institute (NCI) study based on the same CAR construct, a
low-dose cyclophosphamide-fludaribine conditioning regimen, and
Kite’s proprietary manufacturing process (Kochenderfer ASCO
2016).
“ZUMA-1 enrolled patients with chemorefractory aggressive NHL, a
disease that is very difficult to treat. The combined CR rate
of 39 percent at three months is very exciting as it represents
nearly a five-fold increase from the CR rate of 8 percent seen in
the SCHOLAR-1 study in a similar patient population,” said Jeff
Wiezorek, M.D., Senior Vice President of Clinical Development.
“ZUMA-1 is the largest CAR-T study reported in NHL. We were able to
manufacture KTE-C19 for 99 percent of patients enrolled in the
study, and successfully handle the study logistics and adverse
event management at over 20 sites, most of which had no prior
experience in CAR-T therapy.”
Additional data from this interim analysis will be submitted for
presentation at an upcoming scientific meeting. The primary
analysis of 101 patients with chemorefractory aggressive NHL
(DLBCL, TFL and PMBCL) will include approximately six months of
follow-up and is expected in the first quarter of 2017.
“We are grateful to the study participants and investigators who
have made this important research possible. What started at the NCI
over a decade ago with the pioneering work of Steven A. Rosenberg,
M.D., Ph.D., has evolved into a technology that has the potential
to fundamentally change the outlook of patients with cancer. For
patients with aggressive NHL, every day matters and a new treatment
option like KTE-C19 is desperately needed,” said Arie Belldegrun,
M.D., FACS, Chairman, President and Chief Executive Officer of
Kite. “I am proud of what we have achieved to date and excited to
apply our advanced learnings from ZUMA-1 to our ongoing clinical
development programs to bring continued innovation to patients and
the scientific community at large.”
ZUMA-1 is supported in part by funding from The Leukemia &
Lymphoma Society (LLS) Therapy Acceleration Program®.
Conference Call and Webcast Details
Kite will host a live conference call and webcast today
at 4:30PM Eastern Time (1:30PM Pacific Time) to discuss
the results of this interim analysis. To access the live conference
call by telephone, please dial (877) 301-8565 (U.S.) or (678)
562-4240 (International). The conference ID number for the live
call is 88811489. The webcast will be made available on the
Company's website at www.kitepharma.com under the Investors tab in
the Events and Presentations section. Following the live audio
webcast, a replay will be available on the Company's website for
approximately 30 days.
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 chimeric antigen receptor (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 DLBCL, TFL, and 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.
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: expectations regarding the clinical effectiveness and
safety of KTE-C19 and timing of the primary analysis of ZUMA-1.
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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160926006368/en/
Kite Pharma, Inc.Christine CassianoSVP, Corporate Communications
& Investor Relationsccassiano@kitepharma.comorGreg MannVP,
Investor Relationsgmann@kitepharma.com
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