European CHMP Adopts Positive Opinion for Kite’s KTE-X19 for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
October 16 2020 - 7:28AM
Business Wire
-- If Approved, KTE-X19 will be an Important
New Advance for this Disease with a Poor Prognosis --
-- Kite would Become the First Company with
Multiple Approved CAR T Therapies in Europe --
Kite, a Gilead Company (Nasdaq: GILD), today announced that the
European Medicines Agency (EMA) Committee for Medicinal Products
for Human Use (CHMP) has issued a positive opinion on the company’s
Marketing Authorization Application for KTE-X19, a chimeric antigen
receptor (CAR) T cell therapy, as a potential treatment 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. The CHMP opinion recommends conditional
authorization, an early access pathway for medicines that show
promising therapeutic effects, but for which comprehensive data are
not available. The CHMP recommendation was based on the positive
benefit-risk for KTE-X19 as demonstrated from the safety and
efficacy results of the ZUMA-2 trial.
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 Bruton’s tyrosine kinase
(BTK) 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.
“This opinion is an important milestone for patients in Europe
living with relapsed or refractory mantle cell lymphoma,” said Ken
Takeshita, MD, Kite’s Global Head of Clinical Development. “Kite is
committed to bringing the promise of CAR T cell therapy to patients
with hematological cancers and, pending approval by European
Commission, we hope to bring this innovative treatment option
forward for patients in Europe as quickly as possible.”
KTE-X19 is an autologous, anti-CD19 CAR T cell therapy, an
individualized method of treatment that harnesses the body’s own
immune system to target cancer cells. KTE-X19 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, KTE-X19
was granted Priority Medicines (PRIME) designation by the EMA.
In Europe, KTE-X19 is not yet approved and remains
investigational with its efficacy and safety not established. The
European Commission will now review the CHMP recommendation and the
final decision on the Marketing Authorization is expected in the
coming months.
Conditional marketing authorization in Europe is initially valid
for one year but can be extended or converted into an unconditional
marketing authorization 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.
About ZUMA 2
The Marketing Authorization Application of KTE-X19 is supported
by data from the ongoing, multinational, single arm, Phase 2,
open-label ZUMA-2 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 Bruton tyrosine
kinase inhibitor (ibrutinib or acalabrutinib). 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. KTE-X19 was manufactured for 71 patients and
administered to 68 patients.
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 physicians and patients may not see the
potential benefits of KTE-X19 therapy and the possibility of
unfavorable results from other ongoing and additional clinical
studies involving KTE-X19 for the treatment of adult patients with
relapsed or refractory mantle cell lymphoma and other potential
indications. There is also the risk that the European Commission
may not approve KTE-X19 for the treatment of relapsed or refractory
mantle cell lymphoma in the anticipated timelines or at all, and
the marketing approval, if granted, may have significant
limitations on its use. 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 June 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.
In the EU, KTE-X19 is investigational and not
approved. Its efficacy and safety have not been established. More
information about clinical trials with KTE-X19 is available at
www.clinicaltrials.gov.
Kite, the Kite logo, 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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Douglas Maffei, PhD, Investors (650) 522-2739
Nathan Kaiser, Media (650) 522-1853
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