December 11, 2017
-- Phase 1 Data for KTE-C19 Demonstrates High Rates of Response --
-- Results Presented at the Annual Meeting of the
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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
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
KTE-C19 for ALL is investigational and has not been proven safe or efficacious.
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,
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
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.
Sung Lee, 650-524-7792
Nathan Kaiser, 650-522-1853