-- 85 Percent of Patients Responded to a
Single Infusion of Yescarta, Including 74 Percent of Patients
Achieving Complete Response --
-- ZUMA-12 Results Are First to Support
Potential of CAR T in Earlier Lines of Therapy --
Kite, a Gilead Company (Nasdaq: GILD), today announced results
from the interim analysis of ZUMA-12, a multicenter, open-label,
single-arm Phase 2 study evaluating Yescarta® (axicabtagene
ciloleucel) as first-line therapy in patients with high-risk large
B-cell lymphoma (LBCL). After a single infusion of Yescarta, 85
percent of patients achieved a response (n=27 evaluable for
efficacy), including 74 percent of patients with a complete
response. The data were presented in an oral session during the
62nd American Society of Hematology (ASH) Annual Meeting and
Exposition (Abstract #405).
“Despite well-established standard treatment regimens in newly
diagnosed large B-cell lymphoma, patients with high-risk disease
are underserved by currently available treatment options,” said
Sattva S. Neelapu, MD, Professor, Department of Lymphoma and
Myeloma at The University of Texas MD Anderson Cancer Center. “Only
half of these patients achieve long-term remission with standard
first-line therapy, so there is a major need for therapies with
potential to improve outcomes for more patients. These early
results from the ZUMA-12 trial are highly encouraging for the
potential of CAR T in this earlier setting in patients with high
risk.”
Among evaluable patients with centrally confirmed high-risk LBCL
with at least one month of follow-up (n=27), 85 percent of patients
responded, including 74 percent with a complete response. With a
median follow-up of 9.3 months, 70 percent of response-evaluable
patients were in an ongoing response at data cut-off, per
investigator assessment. Median progression-free survival, median
overall survival and median duration of response were not reached
after a median follow-up of 9.5 months.
Among all safety-evaluable patients who received any dose of
Yescarta with at least one month of follow-up (n=32), Grade 3 or
higher cytokine release syndrome (CRS) and neurologic events (NE)
occurred in 9 percent and 25 percent of patients, respectively. No
Grade 5 CRS or NEs occurred. There was one Grade 5 adverse event
due to COVID-19.
“Yescarta has already presented four-year survival data in
patients with third-line refractory LBCL and we are now excited for
what these ZUMA-12 results signal for its potential in earlier
lines of treatment,” said Ken Takeshita, MD, Kite’s Global Head of
Clinical Development. “As the first positive results for a CAR T as
a first-line therapy, these data are a tremendous step forward as
we work to bring the benefits of Yescarta to more patients with
this disease.”
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 chimeric antigen receptor (CAR) T cell
therapy to be approved by the 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 (PMBCL), and high grade B-cell
lymphoma and DLBCL arising from FL. 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 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.
About ZUMA-12
ZUMA-12 is a multicenter, open-label, single-arm Phase 2 study
that aims to enroll approximately 40 adult patients (≥18 years old)
with high-risk LBCL. Patients who met the following criteria for
high-risk LBCL were considered eligible for the study: double- or
triple-hit lymphoma by fluorescent in situ hybridization per
investigator or LBCL with IPI score ≥3; and positive interim PET
per Lugano Classification after two cycles of an anti-CD20
monoclonal antibody- and anthracycline-containing regimen. Patients
underwent leukapheresis (≥ two weeks after prior systemic therapy)
and optional non-chemotherapy bridging at investigator discretion,
followed by conditioning chemotherapy.
The primary endpoint of the trial is complete response rate per
the Lugano Classification. Key secondary objectives include
objective response rate, duration of response, event-free survival
(EFS), progression-free survival, overall survival, frequency of
adverse events, and levels of CAR T cells and cytokines in blood
and serum. The study is ongoing.
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 of unfavorable results from the ongoing trial of
Yescarta as part of first-line therapy in LBCL. There is also the
possibility of unfavorable results from other ongoing and
additional clinical trials 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/20201206005008/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Nathan Kaiser, Media (650) 522-1853
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