-- New Safety Data Involving Steroid Use and
New Subpopulation Analyses from Pivotal ZUMA-1 Trial to Provide
Greater Understanding of Yescarta® in Patients with
Relapsed or Refractory Large B-cell Lymphoma --
-- End of Phase 1 Results from ZUMA-3
Evaluating KTE-X19 in Adults with Relapsed or Refractory Acute
Lymphoblastic Leukemia to be Presented --
Kite, a Gilead Company (Nasdaq: GILD), today announced
that new data from its cell therapy programs will be presented at
the 55th Annual Meeting of the American Society of Clinical
Oncology (ASCO) being held in Chicago from May 31 – June 4, 2019.
Six abstracts highlighting updated Yescarta® (axicabtagene
ciloleucel) efficacy and safety results, and ongoing research from
the company’s chimeric antigen receptor T (CAR T) cell therapy
development program in hematologic malignancies will be presented
at the meeting.
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the full release here:
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“Our CAR T research program is progressing at a rapid pace and
we are excited to share the latest data at ASCO,” said John
McHutchison, AO, MD, Chief Scientific Officer and Head of Research
and Development, Gilead Sciences. “Our data at this year’s meeting
will include new analyses from the pivotal ZUMA-1 trial of
Yescarta, early results from a novel approach to improve the
Yescarta safety profile and results from the ZUMA-3 trial of our
investigational CAR T therapy KTE-X19 in adults with acute
lymphoblastic leukemia. These findings will help physicians better
assess the potential role of CAR T in patients with high unmet need
and continue to build upon our understanding of cell therapy.”
Data from the ZUMA CAR T cell therapy development program to be
presented at the meeting include new results evaluating earlier
steroid use on the rates of adverse events in patients with
relapsed or refractory large B-cell lymphoma treated with Yescarta,
as well as a separate subpopulation analysis of efficacy and safety
results in refractory large B-cell lymphoma patients over the age
of 65 in the ZUMA-1 trial. End of Phase 1 data from the ZUMA-3
trial of investigational KTE-X19 in adult patients with relapsed or
refractory acute lymphoblastic leukemia (ALL) will also be
presented.
Details on Kite cell therapy data to be presented at the meeting
include:
Area of Focus,
PresentationNumber and Date/Time(CDT)
Abstract Title Presentations
Acute Lymphoblastic LeukemiaAbstract #7006
(Oral)Saturday, June 1 (5:00-5:12 pm)
End of Phase 1 Results of ZUMA-3, a Phase 1/2 Study of
KTE-X19, Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in
Adult Patients with Relapsed/Refractory Acute Lymphoblastic
Leukemia
Large B-Cell LymphomaAbstract #7555
(Poster)Monday, June 3 (8:00-11:00 am)
Outcomes of Patients ≥ 65 Years of Age in ZUMA-1, a Pivotal
Phase 1/2 Study of Axicabtagene Ciloleucel in Refractory Large
B-Cell Lymphoma
Large B-Cell LymphomaAbstract #7558
(Poster)Monday, June 3 (8:00-11:00 am)
Preliminary Results of Earlier Steroid Use with Axicabtagene
Ciloleucel in Patients with Relapsed/Refractory Large B-Cell
Lymphoma
Large B-Cell LymphomaAbstract #7545
(Poster)Monday, June 3 (8:00-11:00 am)
Hematopoietic Recovery and Immune Reconstitution After
Axicabtagene Ciloleucel Chimeric Antigen Receptor T Cell Therapy in
Patients with Relapsed/Refractory Large B-cell Lymphoma
Trials-In-Progress
Chronic Lymphocytic LeukemiaAbstract
#TPS7566 (Poster)Monday, June 3 (8:00-11:00 am)
ZUMA-8: A Phase 1/2 Multicenter Study Evaluating KTE-X19 in
Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
Large B-Cell LymphomaAbstract #TPS7574
(Poster)Monday, June 3 (8:00-11:00 am)
ZUMA-12: A Phase 2 Multicenter Study of Axicabtagene
Ciloleucel as a First-Line Therapy in Patients with High-Risk Large
B-Cell Lymphoma
For more information, including a complete list of abstract
titles at the meeting, please visit:
https://meetinglibrary.asco.org/.
Yescarta was the first CAR T cell therapy to be approved by the
U.S. Food and Drug Administration (FDA) for the treatment of adult
patients with relapsed or refractory large B-cell lymphoma after
two or more lines of systemic therapy, including diffuse large
B-cell lymphoma (DLBCL) not otherwise specified, primary
mediastinal large B-cell lymphoma, and high grade B-cell lymphoma
and DLBCL arising from follicular lymphoma. Yescarta is not
indicated for the treatment of patients with primary central
nervous system lymphoma. The Yescarta U.S. Prescribing Information
has a BOXED WARNING for the risks of cytokine release syndrome and
neurologic toxicities; see below for Important Safety
Information.
KTE-X19 is an investigational agent that has not been approved
by the U.S. Food and Drug Administration or any regulatory
authority for any uses. Efficacy and safety have not yet been
established.
U.S. Important Safety Information for
Yescarta
BOXED WARNING: CYTOKINE RELEASE SYNDROME AND
NEUROLOGIC TOXICITIES
- Cytokine Release Syndrome (CRS),
including fatal or life-threatening reactions, occurred in patients
receiving Yescarta. Do not administer Yescarta to patients with
active infection or inflammatory disorders. Treat severe or
life-threatening CRS with tocilizumab or tocilizumab and
corticosteroids.
- Neurologic toxicities, including
fatal or life-threatening reactions, occurred in patients receiving
Yescarta, including concurrently with CRS or after CRS resolution.
Monitor for neurologic toxicities after treatment with Yescarta.
Provide supportive care and/or corticosteroids as needed.
- Yescarta is available only through a
restricted program under a Risk Evaluation and Mitigation Strategy
(REMS) called the Yescarta REMS.
CYTOKINE RELEASE SYNDROME (CRS): CRS occurred in 94% of
patients, including 13% with ≥ Grade 3. Among patients who died
after receiving Yescarta, 4 had ongoing CRS at death. The median
time to onset was 2 days (range: 1-12 days) and median duration was
7 days (range: 2-58 days). Key manifestations include fever (78%),
hypotension (41%), tachycardia (28%), hypoxia (22%), and chills
(20%). Serious events that may be associated with CRS include
cardiac arrhythmias (including atrial fibrillation and ventricular
tachycardia), cardiac arrest, cardiac failure, renal insufficiency,
capillary leak syndrome, hypotension, hypoxia, and hemophagocytic
lymphohistiocytosis/macrophage activation syndrome. Ensure that 2
doses of tocilizumab are available prior to infusion of Yescarta.
Monitor patients at least daily for 7 days at the certified
healthcare facility following infusion for signs and symptoms of
CRS. Monitor patients for signs or symptoms of CRS for 4 weeks
after infusion. Counsel patients to seek immediate medical
attention should signs or symptoms of CRS occur at any time. At the
first sign of CRS, institute treatment with supportive care,
tocilizumab or tocilizumab and corticosteroids as indicated.
NEUROLOGIC TOXICITIES: Neurologic toxicities occurred in
87% of patients. Ninety-eight percent of all neurologic toxicities
occurred within the first 8 weeks, with a median time to onset of 4
days (range: 1-43 days) and a median duration of 17 days. Grade 3
or higher occurred in 31% of patients. The most common neurologic
toxicities included encephalopathy (57%), headache (44%), tremor
(31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia
(9%) and anxiety (9%). Prolonged encephalopathy lasting up to 173
days was noted. Serious events including leukoencephalopathy and
seizures occurred with Yescarta. Fatal and serious cases of
cerebral edema have occurred in patients treated with
Yescarta. Monitor patients at least daily for 7 days at the
certified healthcare facility following infusion for signs and
symptoms of neurologic toxicities. Monitor patients for signs or
symptoms of neurologic toxicities for 4 weeks after infusion and
treat promptly.
YESCARTA REMS: Because of the risk of CRS and neurologic
toxicities, Yescarta is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
Yescarta REMS. The required components of the Yescarta REMS are:
Healthcare facilities that dispense and administer Yescarta must be
enrolled and comply with the REMS requirements. Certified
healthcare facilities must have on-site, immediate access to
tocilizumab, and ensure that a minimum of 2 doses of tocilizumab
are available for each patient for infusion within 2 hours after
Yescarta infusion, if needed for treatment of CRS. Certified
healthcare facilities must ensure that healthcare providers who
prescribe, dispense or administer Yescarta are trained about the
management of CRS and neurologic toxicities. Further information is
available at www.YESCARTAREMS.com or 1-844-454-KITE (5483).
HYPERSENSITIVITY REACTIONS: Allergic reactions may occur.
Serious hypersensitivity reactions including anaphylaxis may be due
to dimethyl sulfoxide (DMSO) or residual gentamicin in
Yescarta.
SERIOUS INFECTIONS: Severe or life-threatening infections
occurred. Infections (all grades) occurred in 38% of patients, and
in 23% with ≥ Grade 3. Grade 3 or higher infections with an
unspecified pathogen occurred in 16% of patients, bacterial
infections in 9%, and viral infections in 4%. Yescarta should not
be administered to patients with clinically significant active
systemic infections. Monitor patients for signs and symptoms of
infection before and after Yescarta infusion and treat
appropriately. Administer prophylactic anti-microbials according to
local guidelines. Febrile neutropenia was observed in 36% of
patients and may be concurrent with CRS. In the event of febrile
neutropenia, evaluate for infection and manage with broad spectrum
antibiotics, fluids and other supportive care as medically
indicated. Hepatitis B virus (HBV) reactivation, in some cases
resulting in fulminant hepatitis, hepatic failure and death, can
occur in patients treated with drugs directed against B cells.
Perform screening for HBV, HCV, and HIV in accordance with clinical
guidelines before collection of cells for manufacturing.
PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for
several weeks following lymphodepleting chemotherapy and Yescarta
infusion. Grade 3 or higher cytopenias not resolved by Day 30
following Yescarta infusion occurred in 28% of patients and
included thrombocytopenia (18%), neutropenia (15%), and anemia
(3%). Monitor blood counts after Yescarta infusion.
HYPOGAMMAGLOBULINEMIA: B-cell aplasia and
hypogammaglobulinemia can occur. Hypogammaglobulinemia occurred in
15% of patients. Monitor immunoglobulin levels after treatment and
manage using infection precautions, antibiotic prophylaxis and
immunoglobulin replacement. The safety of immunization with live
viral vaccines during or following Yescarta treatment has not been
studied. Vaccination with live virus vaccines is not recommended
for at least 6 weeks prior to the start of lymphodepleting
chemotherapy, during Yescarta treatment, and until immune recovery
following treatment.
SECONDARY MALIGNANCIES: Patients may develop secondary
malignancies. Monitor life-long for secondary malignancies. In the
event that a secondary malignancy occurs, contact Kite at
1-844-454-KITE (5483) to obtain instructions on patient samples to
collect for testing.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the
potential for neurologic events, including altered mental status or
seizures, patients are at risk for altered or decreased
consciousness or coordination in the 8 weeks following Yescarta
infusion. Advise patients to refrain from driving and engaging in
hazardous occupations or activities, such as operating heavy or
potentially dangerous machinery, during this initial period.
ADVERSE REACTIONS: The most common adverse reactions
(incidence ≥ 20%) include CRS, fever, hypotension, encephalopathy,
tachycardia, fatigue, headache, decreased appetite, chills,
diarrhea, febrile neutropenia, infections-pathogen unspecified,
nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation,
and cardiac arrhythmias.
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 the possibility of unfavorable results from ongoing and
additional clinical trials involving Yescarta or KTE-X19. 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.
U.S. Prescribing Information for Yescarta,
including BOXED WARNING, is available at www.kitepharma.com
and www.gilead.com.
Yescarta is a registered trademark
of Gilead Sciences, Inc., or its related companies.
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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version on businesswire.com: https://www.businesswire.com/news/home/20190515005176/en/
Sung Lee, Investors(650) 524-7792
Nathan Kaiser, Media(650) 522-1853
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