Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia
December 11 2017 - 7:30PM
Business Wire
-- Phase 1 Data for KTE-C19 Demonstrates
High Rates of Response --
-- Results Presented at the Annual Meeting
of the American Society of Hematology --
Kite, a Gilead Company (Nasdaq: GILD), announced updated results
from the ongoing Phase 1/2 ZUMA-3 study of KTE-C19, a CD19 chimeric
antigen receptor T (CAR T) cell therapy, which is investigational
for the treatment of adult patients with relapsed or refractory
acute lymphoblastic leukemia (ALL). With a minimum of eight weeks
of follow-up, 71 percent of ALL patients (n=17/24) who received a
single infusion of KTE-C19 achieved complete tumor remission
(complete remission (CR) or CR with incomplete hematological
recovery). The ZUMA-3 study results were presented in an oral
session at the Annual Meeting of the American Society of Hematology
(ASH) in Atlanta.
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ALL is an aggressive type of blood cancer which can also involve
the lymph nodes, spleen, liver, central nervous system and other
organs.
“Approximately half of new ALL cases occur in adults age 20 or
older and a majority of adult ALL patients relapse and have poor
subsequent outcomes,” said Bijal Shah, MD, ZUMA-3 investigator and
medical oncologist, Moffitt Cancer Center, Tampa, Fla. “The deep
remissions seen with these early study results offer promise that
adults with this aggressive disease may benefit from personalized
cell therapy with KTE-C19. Pending further clinical evaluation,
this has the potential to be an advance for adults with no other
treatment options.”
ZUMA-3 is an ongoing multicenter Phase 1/2 study in patients
with ALL whose disease is refractory to or has relapsed following
standard chemotherapy or hematopoietic stem cell transplantation.
The objectives of the study are to evaluate the safety and efficacy
of KTE-C19 in this patient population.
At the time of data cutoff, 24 patients were evaluable for
response. KTE-C19 demonstrated a 71 percent (n=17/24) rate of
complete remission, with 100 percent of responders having no
detectable minimal residual disease, including in those with high
tumor burden and high risk genetic abnormalities.
In the safety analysis of 29 patients, adverse events were
consistent with the known toxicities of CD19 CAR T treatment,
including Grade 3 or higher cytokine release syndrome (CRS) and
neurologic toxicities in 28 percent (n=8/29) and 52 percent of
patients (n=15/29), respectively. Two patients receiving KTE-C19
died due to adverse events, including one patient with a
cerebrovascular accident not related to KTE-C19 treatment
approximately seven weeks after treatment and a previously reported
patient who experienced fatal CRS.
“We believe personalized cell therapy has the potential to
become a cornerstone of cancer treatment and are rapidly advancing
CAR T studies in ALL and in other cancers,” said David Chang, MD,
PhD, Worldwide Head of Research and Development and Chief Medical
Officer at Kite. “ZUMA-3 is reflective of our continued commitment
to cell therapy cancer treatment and we are pleased to see these
early results for people living with ALL.”
KTE-C19 for ALL is investigational and has not been proven safe
or efficacious.
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 is a biopharmaceutical company that
discovers, develops and commercializes innovative therapeutics in
areas of unmet medical need. The company’s mission is to advance
the care of patients suffering from life-threatening diseases.
Gilead has operations in more than 30 countries worldwide, with
headquarters in Foster City, California.
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 future clinical trials involving KTE-C19
may have unfavorable results. As a result, KTE-C19 may not be
commercialized for ALL or other investigational indications. All
statements other than statements of historical fact are statements
that could be deemed forward-looking statements. Investors are
cautioned that any such forward-looking statements are not
guarantees of future performance and involve risks and
uncertainties and are cautioned not to place undue reliance on
these forward-looking statements. Actual results may differ
materially from those currently anticipated due to a number of
risks and uncertainties. Risks and uncertainties that could cause
the actual results to differ from expectations contemplated by
forward-looking statements include risks and uncertainties detailed
from time to time in Gilead Sciences, Inc.’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2017 as filed with
the 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 and disclaim any
intent to update any such forward-looking statements.
For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com, follow
Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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version on businesswire.com: http://www.businesswire.com/news/home/20171211005311/en/
Gilead SciencesSung Lee, 650-524-7792InvestorsorNathan Kaiser,
650-522-1853Media
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