U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cel...
February 10 2020 - 8:30AM
Business Wire
-- If Approved, Kite Could be First Company
with Multiple Commercialized CAR T Therapies --
Kite, a Gilead Company (Nasdaq: GILD), today announced that the
U.S. Food and Drug Administration (FDA) has accepted the Biologics
License Application (BLA) and granted Priority Review designation
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).
The BLA is supported by data from the single arm, open-label,
Phase 2 ZUMA-2 trial, which showed that 93 percent of patients
responded to a single infusion of KTE-X19, including 67 percent of
patients achieving a complete response, as assessed by an
Independent Radiologic Review Committee (IRRC; 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.
“Despite recent advances, patients with relapsed/refractory
mantle cell lymphoma currently face a significant lack of effective
treatment options once their disease no longer responds to
currently available therapy,” said Ken Takeshita, MD, Kite’s Global
Head of Clinical Development. “Based on the encouraging results for
KTE-X19, we are eager to continue discussions with the FDA on how
to bring this innovative treatment to these patients who may
benefit from CAR T therapy.”
The Prescription Drug User Fee Act (PDUFA), or target action
date, is August 10, 2020. The European Medicines Agency (EMA)
recently validated the Marketing Authorization Application for
KTE-X19 in the European Union. KTE-X19 has been granted
Breakthrough Therapy Designation (BTD) by the FDA and Priority
Medicines (PRIME) designation by the EMA for relapsed or refractory
MCL.
KTE-X19 is investigational and not yet approved in any country
globally. Its efficacy and safety have not been established. A
final decision by the FDA is anticipated by August. 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 and the European Commission may not
approve KTE-X19 for the treatment of adult patients with relapsed
or refractory MCL in the anticipated timelines or at all, 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/20200210005203/en/
Douglas Maffei, Investors (650) 522-2739 Nathan Kaiser, Media
(650) 522-1853
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