European Medicines Agency Validates Kite’s Marketing Application for Company’s Second CAR T Cell Therapy
January 28 2020 - 4:15PM
Business Wire
-- Investigational KTE-X19 To Be First
Chimeric Antigen Receptor (CAR) T Cell Therapy for Mantle Cell
Lymphoma in Europe if Approved --
-- Filing for Kite’s Second CAR T Therapy
Marks Potential Expansion of Company’s Cell Therapy Portfolio
--
Kite, a Gilead Company (Nasdaq: GILD), today announced that the
company’s Marketing Authorization Application (MAA) for KTE-X19, an
investigational chimeric antigen receptor (CAR) T cell therapy for
the treatment of adult patients with relapsed or refractory mantle
cell lymphoma (MCL), has been fully validated and is now under
evaluation by the European Medicines Agency (EMA).
The MAA is supported by data from the single arm, open-label,
Phase 2 ZUMA-2 trial, which demonstrated an overall response rate
of 93 percent, including 67 percent with complete response, as
assessed by an Independent Radiologic Review Committee (IRRC)
following a single infusion of KTE-X19 (median follow-up of 12.3
months). In the safety analysis, Grade 3 or higher cytokine release
syndrome (CRS) and neurologic events were seen in 15 percent and 31
percent of patients, respectively. No Grade 5 CRS or neurologic
events occurred. Detailed findings from this trial were recently
presented during an oral session at the 61st American Society of
Hematology (ASH) Annual Meeting & Exposition in Orlando.
“Relapse rates in mantle cell lymphoma remain overwhelmingly
high and there is a significant need for new therapies that may
improve patients’ prognosis,” said Ken Takeshita, MD, Kite’s Global
Head of Clinical Development. “The EMA validation of our marketing
application brings us closer to delivering on the promise of our
industry-leading cell therapy development program, with the hope
that we can bring KTE-X19 to appropriate patients in Europe as
quickly as possible.”
Kite submitted a Biologics License Application (BLA) for KTE-X19
to the U.S. Food and Drug Administration (FDA) on December 11, 2019
for the treatment of adult patients with relapsed or refractory
MCL. KTE-X19 has been granted Breakthrough Therapy Designation
(BTD) by the FDA and Priority Medicines (PRIME) by the EMA.
KTE-X19 is investigational and not approved anywhere globally.
Its efficacy and safety have not been established. More information
about clinical trials with KTE-X19 is available at
www.clinicaltrials.gov.
About MCL
MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises
from cells originating in the “mantle zone” of the lymph node and
typically affects men over the age of 60.
About ZUMA-2
ZUMA-2 is a single-arm, multicenter, open-label Phase 2 study
involving 74 enrolled/leukapheresed adult patients (≥18 years old)
with MCL whose disease is refractory to or has relapsed following
up to five prior lines of therapy, including anthracycline or
bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody
therapy and the BTK inhibitors ibrutinib or acalabrutinib. The
objectives of the study are to evaluate the efficacy (60 patients)
and safety (68 patients) after a single infusion of KTE-X19 in this
patient population. The primary endpoint for the study is objective
response rate (ORR). ORR in this trial is defined as the combined
rate of complete responses and partial responses as assessed by an
IRRC.
Secondary endpoints include duration of response,
progression-free survival, overall survival, incidence of adverse
events, incidence of anti-CD19 CAR antibodies, levels of anti-CD19
CAR T cells in blood, levels of cytokines in serum, and changes
over time in the EQ-5D scale score and visual analogue scale score.
The study is ongoing.
About KTE-X19
KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell
therapy. KTE-X19 uses the XLP™ manufacturing process that includes
T-cell selection and lymphocyte enrichment. Lymphocyte enrichment
is a necessary step in certain B-cell malignancies in which
circulating lymphoblasts are a common feature. KTE-X19 is currently
in Phase 1/2 trials in acute lymphoblastic leukemia (ALL), mantle
cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in
Santa Monica, California. Kite is engaged in the development of
innovative cancer immunotherapies. The company is focused on
chimeric antigen receptor and T cell receptor engineered cell
therapies. For more information on Kite, please visit
www.kitepharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com.
Forward-Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the risk that FDA, EMA and other regulatory agencies may
not approve KTE-X19 for the treatment of adult patients with
relapsed or refractory MCL, and any marketing approvals, if
granted, may have significant limitations on its use. There is also
the possibility of unfavorable results from other ongoing and
additional clinical trials involving KTE-X19. All statements other
than statements of historical fact are statements that could be
deemed forward-looking statements. These risks, uncertainties and
other factors could cause actual results to differ materially from
those referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements. These
and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2019, as
filed with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to Gilead and Kite, and Gilead and Kite assume no
obligation to update any such forward-looking statements.
XLP is a trademark of Gilead Sciences, Inc., or
its related companies.
For more information on Kite, please visit the
company’s website at www.kitepharma.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social
media on Twitter (@KitePharma) and LinkedIn.
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version on businesswire.com: https://www.businesswire.com/news/home/20200128005723/en/
Douglas Maffei, Investors (650) 522-2739
Nathan Kaiser, Media (650) 522-1853
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