-- Unparalleled 44 Percent Estimated
Four-Year Overall Survival Rate Among Refractory Large B-cell
Lymphoma Patients After a Single Infusion of Yescarta --
-- Findings Support Yescarta as the First
Commercially Available CAR T-Cell Therapy to Demonstrate Four-Year
Survival Results in Large B-cell Lymphoma --
Kite, a Gilead Company (Nasdaq: GILD), today announced four-year
follow-up data from the pivotal ZUMA-1 trial of Yescarta®
(axicabtagene ciloleucel) in adult patients with refractory large
B-cell lymphoma (LBCL). Among Yescarta-treated patients (modified
intent to-treat analysis, n=101) with a minimum follow-up of four
years after a single infusion of Yescarta (median follow-up of 51.1
months), the Kaplan-Meier estimate of the four-year overall
survival (OS) rate was 44 percent. The data were presented today at
the 62nd American Society of Hematology (ASH) Annual Meeting and
Exposition (Abstract #1187).
Of 111 patients enrolled in the ZUMA-1 Phase 2 cohorts, Yescarta
was administered to 101 patients with refractory LBCL, and the
median time from leukapheresis to complete response (CR) was less
than two months. There have been no Yescarta-related secondary
malignancies reported.
“With close to half of patients still alive after a single
infusion of axicabtagene ciloleucel, we are transforming the way
relapsed or refractory large B-cell lymphoma can be treated,” said
Frederick L. Locke, MD, ZUMA-1 Co-Lead Investigator and Vice Chair
of the Department of Blood and Marrow Transplant and Cellular
Immunotherapy at Moffitt Cancer Center in Tampa, Florida. “As a
practicing oncologist I continue to see these patients in the
clinic, and this overall survival data confirms the durability of
CAR T-cell therapy in a patient population that previously
exhausted all viable treatment options.”
Blood sample analyses provided by 21 patients who were treated
with Yescarta and showed an ongoing response at a minimum of three
years follow-up also demonstrated that 67 percent (n=14/21) had
detectable CAR gene-marked cells and polyclonal B cells in blood.
Additionally, normal B-cells were present in 91 percent (n=21/23)
of evaluable patients. These results suggest that persistence of
functional CAR T cells is not necessary for durable remissions in
patients with refractory LBCL and may support long-term safety of
the therapy.
“With these first-ever four-year data from a pivotal CAR T
clinical trial in lymphoma, we continue to show the potential
long-term survival of Yescarta in relapsed/refractory large B-cell
lymphoma and push the boundaries of what is possible with this CAR
T treatment,” said Ken Takeshita, MD, Kite’s Global Head of
Clinical Development. “And equally importantly, we are encouraged
by similar trends in long-term survival with real-world experience,
with thousands of patients treated since Yescarta first became
available.”
Kite has presented four-year survival data for Yescarta in the
ZUMA-1 study of patients with refractory large B-cell lymphoma.
Based on these data and other data presented at ASH, Kite believes
that Yescarta could bring the hope of survival to patients with a
number of other hematological malignancies.
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
(CRS) and neurologic toxicities, and Yescarta is approved with a
risk evaluation and mitigation strategy (REMS) due to these risks;
see below for Important Safety Information.
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 and Tecartus REMS Program.
CYTOKINE RELEASE SYNDROME (CRS) occurred in 94% of
patients, with 13% ≥ 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 Yescarta infusion.
Following infusion, monitor patients for signs and symptoms of CRS
at least daily for 7 days at the certified healthcare facility, and
for 4 weeks thereafter. 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 occurred in 87% of patients, 98% of
which 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 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, as well as fatal and serious cases of cerebral edema have
occurred. Following Yescarta infusion, monitor patients for signs
and symptoms of neurologic toxicities at least daily for 7 days at
the certified healthcare facility, and for 4 weeks thereafter, and
treat promptly.
REMS: Because of the risk of CRS and neurologic
toxicities, Yescarta is available only through a restricted program
called the Yescarta and Tecartus REMS Program which requires that:
Healthcare facilities that dispense and administer Yescarta must be
enrolled and comply with the REMS requirements and must have
on-site, immediate access to a minimum of 2 doses of tocilizumab
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.YescartaTecartusREMS.com or 1-844-454-KITE (5483).
HYPERSENSITIVITY REACTIONS: Allergic reactions, including
serious hypersensitivity reactions or anaphylaxis, may occur with
the infusion of Yescarta.
SERIOUS INFECTIONS: Severe or life-threatening infections
occurred. Infections (all grades) occurred in 38% of patients.
Grade ≥3 infections occurred in 23% of patients; those due to 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 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 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 infusion.
HYPOGAMMAGLOBULINEMIA and B-cell aplasia 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 may develop. Monitor life-long for
secondary malignancies. In the event that one 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 (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.
Please see full Prescribing Information, including BOXED
WARNING and Medication Guide.
About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in
Santa Monica, California, with commercial manufacturing operations
in North America and Europe. 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 risk that physicians and patients may not see the
potential benefits of Yescarta therapy and the possibility of
unfavorable results from other ongoing and additional clinical
studies involving Yescarta. 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 September 30, 2020, 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.
Kite, the Kite logo, Yescarta, Tecartus and
GILEAD are trademarks of Gilead Sciences, Inc. or its related
companies.
For more information on Kite, please visit the
company’s website at www.kitepharma.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social
media on Twitter (@KitePharma) and LinkedIn.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201205005006/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Nathan Kaiser, Media (650) 522-1853
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