-- Data Show High Rates of Response to
Single Infusion of KTE-X19 --
-- Phase 2 Portion of ZUMA-3 is Ongoing and
Includes Dosing and Revised Safety Management Protocol Studied in
Phase 1 --
Kite, a Gilead Company (Nasdaq: GILD), today announced results
from the completed Phase 1 of the ZUMA-3 study evaluating KTE-X19,
an investigational CD19 chimeric antigen receptor T (CAR T) cell
therapy. ZUMA-3 is a single-arm Phase 1/2 study in adult patients
with relapsed or refractory acute lymphoblastic leukemia (ALL). The
results provide guidance on dosing and safety management for
KTE-X19 to inform the ongoing Phase 2 study. The data were
presented during an oral session at the 2019 American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31 – June 4
(Abstract #7006).
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By the end of Phase 1, 45 patients received KTE-X19 at one of
three different doses levels [2 x 106 cells/kg (n=6), 1 x 106
cells/kg (n=23), or 0.5 x 106 cells/kg (n=16)]. Patients enrolled
in this study were primary refractory or relapsed/refractory after
at least two prior lines of therapy. Of 41 patients who were
evaluable for efficacy after a minimum two months of follow-up
(median follow-up of 16 months), 68 percent achieved complete
response (CR) or CR with incomplete hematological recovery (CRi)
and 100 percent of responders had undetectable minimal residual
disease (MRD). Of the 23 patients treated with the dose level that
will be used in the ongoing Phase 2 study (1 x 106 cells/kg), 19
were evaluable for efficacy. At the time of data cut-off (median
duration of remission = 12.9 months), 16 (84 percent) patients
achieved CR or CRi, and 12 patients (75 percent) were in ongoing
response.
No dose-limiting toxicities (DLTs) were identified. Grade ≥3
cytokine release syndrome (CRS) events and neurologic events
occurred in 29 percent and 38 percent of all patients,
respectively. As previously reported, two patients experienced
KTE-X19–related Grade 5 adverse events (AEs) during the study; one
developed stroke in the context of CRS and neurologic events, and
one experienced multiorgan failure secondary to CRS. Among patients
receiving 1 x 106 cell/kg (n=23), 26 percent experienced Grade ≥3
CRS, and 43 percent experienced Grade ≥3 neurologic events.
A revised AE management protocol was implemented in nine
patients treated with 1 x106 cells/kg of KTE-X19 during the study.
In this revised protocol, corticosteroids were initiated at onset
of Grade ≥2 neurologic events (versus previous onset of Grade 3)
and tocilizumab was only given for management of toxicities in the
context of CRS (versus prophylactic administration in Cohort 2). Of
those patients, two (22 percent) had Grade 3 CRS and one (11
percent) had Grade 3 neurologic events. There were no Grade 4/5
events.
“Adults with relapsed or refractory ALL represent an extremely
difficult-to-treat patient population,” said Bijal Shah, MD, ZUMA-3
investigator and medical oncologist, Moffitt Cancer Center, Tampa,
Florida. “We’re encouraged by the high response rates in this
study, as well as the reduced incidence and severity of CRS and
neurologic events that were observed following implementation of
the revised safety management protocol. We are now evaluating the
use of KTE-X19 at the selected dose with this safety management
protocol in the ongoing ZUMA-3 Phase 2 study.”
“The completion of the Phase 1 portion of the ZUMA-3 trial is an
important milestone for our second investigational CAR T cell
therapy,” said John McHutchison, AO, MD, Chief Scientific Officer,
Head of Research and Development, Gilead. “We are pleased with the
high response rates observed with KTE-X19 in this trial, and the
progress of our broader effort aimed to further improve the
benefit/risk profile of CAR T therapy through the investigation of
novel safety management approaches.”
This abstract has also been selected to be included in the 2019
Best of ASCO® program, which will be held this summer following the
ASCO Annual Meeting.
KTE-X19 is an investigational therapy that has not been approved
by the U.S. Food and Drug Administration (FDA) or any regulatory
authority 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 years old) 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 KTE-X19
KTE-X19 is an investigational CD19 CAR T cell therapy. KTE-X19
has the same construct as axicabtagene ciloleucel; however, the
manufacturing process for KTE-X19 differs from that of axicabtagene
ciloleucel and includes the enrichment of lymphocytes. Lymphocyte
enrichment is necessary in certain B-cell malignancies for which
KTE-X19 in under investigation. KTE-X19 is currently in Phase 1/2
trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma
(MCL) and chronic lymphocytic leukemia (CLL).
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, 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 Kite’s ability to complete Phase 2 of the ZUMA-3 study of
KTE-X19 in adult patients with relapsed or refractory acute
lymphoblastic leukemia in the currently anticipated timelines, or
at all. In addition, there is the possibility of unfavorable
results from other ongoing and additional clinical trials involving
KTE-X19. Further, Kite may be unable to obtain regulatory approval
for KTE-X19 from the FDA or other regulatory authorities. 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 March 31, 2019, 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.
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 1-650-574-300
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version on businesswire.com: https://www.businesswire.com/news/home/20190601005017/en/
Sung Lee, Investors(650) 524-7792Nathan Kaiser, Media(650)
522-1853
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