December 03, 2018
-- Ongoing Phase 1/2 Study Continues to Demonstrate High Rates of Response to a Single Infusion of KTE-X19 in a Patient Population with Limited Treatment Options --
-- Based on these Data, the Phase 2 Portion of ZUMA-3 is Now Enrolling --
-- Findings Presented in an Oral Session at the Annual Meeting of
the
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“We are encouraged by the high number of patients who achieved complete
leukemia remission following a single KTE-X19 infusion on this trial,”
said William G. Wierda, MD, PhD, Executive Medical Director and
Professor,
Adverse events were consistent with the known toxicities of CD19 CAR T treatment, including Grade 3 or higher cytokine release syndrome (CRS) and neurologic events in 23 percent (n=10/44) and 39 percent (n=17/44) of patients, respectively. The majority of these adverse events were resolved, with the exception of two patients who had ongoing neurological events at the time of death from other causes. Two patients died from adverse events deemed by the treating investigator to be related to KTE-X19.
“These updated results from ZUMA-3 provide continued support for the
potential of our CD19-directed CAR T therapies in new types of cancers
and reinforce our leadership in cell therapy,” said
KTE-X19 is an investigational agent that has not been approved for any uses. Efficacy and safety have not been established.
About ALL
ALL is an aggressive type of blood cancer which can also involve the lymph nodes, spleen, liver, central nervous system and other organs.
About ZUMA-3
ZUMA-3 is an ongoing multicenter, registrational Phase 1/2 study in adult patients (≥18) 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-X19 in this patient population.
About Kite
Kite, a
About
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 Kite’s
ability to complete its Phase 2 clinical trial program evaluating
KTE-X19 in the currently anticipated timeline or at all. In addition,
there is the possibility of unfavorable results from ongoing and
additional clinical trials involving KTE-X19. Further, it is possible
that Kite may make a strategic decision to discontinue development of
KTE-X19, and as a result, this compound may never be successfully
commercialized. 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
For more information on Kite, please visit the company’s website at www.kitepharma.com. Learn more about Gilead 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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Source:
Sung Lee, Investors
(650) 524-7792
Nathan Kaiser, Media
(650) 522-1853