-- 93 Percent of Patients in ZUMA-2 Pivotal
Trial Responded to Single Infusion of Tecartus --
-- Tecartus is First CAR T Therapy in
Relapsed or Refractory MCL and Kite Becomes the First Company with
Multiple Approved Cell Therapies in Europe --
Kite, a Gilead Company (Nasdaq: GILD), today announced that the
European Commission has granted conditional marketing authorization
for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells;
formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T
cell therapy for adult patients with relapsed or refractory mantle
cell lymphoma after two or more lines of systemic therapy including
a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional
authorization is granted in the interest of public health where the
benefit of immediate availability outweighs the risk of less
comprehensive data available.
The conditional marketing authorization is supported from the
multinational, single-arm, Phase 2 open-label ZUMA-2 pivotal trial
in patients with relapsed or refractory mantle cell lymphoma who
had previously received anthracycline- or bendamustine-containing
chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor.
ZUMA-2 demonstrated an overall response rate (complete or partial)
of 93 percent, with 67 percent of patients achieving a complete
response, as assessed by an Independent Radiologic Review Committee
following a single infusion of Tecartus. In the safety analyses,
Grade 3 or higher cytokine release syndrome (CRS) and neurologic
events were observed in 15 percent and 33 percent of patients,
respectively.
“Significant gaps in treatment remain for patients with mantle
cell lymphoma who progress following initial therapies,” said
Professor John G. Gribben, Consultant Haematologist and Medical
Oncologist at Barts and The London NHS Trust, London. “The
availability of this first cell therapy for relapsed or refractory
mantle cell lymphoma, following at least two lines of systemic
therapy including a BTK inhibitor, provides an important option for
patients in Europe.”
“Kite is committed to bringing the curative intent potential of
CAR T-cell therapy to patients with hematological cancers,” said
Ken Takeshita, MD, Kite’s Global Head of Clinical Development. We
are proud our second cell therapy has been approved for use in
Europe, and I extend my thanks to the patients who participated in
the clinical trial and their families and caregivers, clinical
researchers, regulators and dedicated colleagues at Kite who helped
make this approval possible for patients living with relapsed or
refractory mantle cell lymphoma.”
Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that
arises from cells originating in the “mantle zone” of the lymph
node and predominantly affects men over the age of 60. Patients
with relapsed or refractory mantle cell lymphoma after two or more
lines of systemic therapy including a BTK inhibitor have a poor
prognosis, with a median overall survival of 6 to 10 months. In
Europe, it is estimated that at least 7,400 people are diagnosed
with mantle cell lymphoma each year.
Tecartus is a CAR T-cell therapy, an individualized method of
treatment that harnesses the body’s own immune system to target
cancer cells. The therapy uses the XLP™ manufacturing process that
includes T cell enrichment, a necessary step in certain B cell
malignancies in which circulating lymphoblasts are a common
feature. In recognition of its potential to benefit patients with
significant unmet medical need, Tecartus was granted Priority
Medicines (PRIME) designation by the EMA.
Conditional marketing authorization in Europe is initially valid
for one year but can be extended or converted into an unconditional
marketing authorisation after the submission and assessment of
additional confirmatory data. Conditional approval is granted to a
medicinal product that fulfils an unmet medical need where the
benefit of immediate availability outweighs the risk of less
comprehensive data than normally required. It requires additional
monitoring and post-marketing data before full approval is
granted.
For full details on the Special Warnings and Precautions for Use
and Adverse Reactions (including appropriate management), please
refer to the EU Summary of Product Characteristics (SmPC).
About ZUMA-2
ZUMA-2 is an ongoing, multinational, single arm, Phase 2
open-label pivotal trial. The study enrolled 74 adult patients with
relapsed or refractory mantle cell lymphoma who had previously
received anthracycline- or bendamustine-containing chemotherapy, an
anti-CD20 antibody therapy and a BTK inhibitor (ibrutinib or
acalabrutinib). The treatment was manufactured for 71 patients and
administered to 68 patients. The primary endpoint was objective
response rate per the Lugano Classification (2014), defined as the
combined rate of complete response and partial responses as
assessed by an Independent Radiologic Review Committee.
About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in
Santa Monica, California, with commercial manufacturing operations
in North America and Europe. 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 the European Commission may not extend or
convert the conditional marketing authorization into an
unconditional marketing authorization for Tecartus for the
treatment of relapsed or refractory mantle cell lymphoma. In
addition, physicians and patients may not see the potential
benefits of Tecartus, and there is the possibility of unfavorable
results from other ongoing and additional clinical studies
involving Tecartus. 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, 2020, 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.
Kite, the Kite logo, Tecartus, XLP and GILEAD
are trademarks 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/20201216005245/en/
Monica Tellado, Investors (650) 219-3882
Nathan Kaiser, Media (650) 522-1853
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