-- 93 Percent of Patients with Relapsed or
Refractory Follicular Lymphoma and Marginal Zone Lymphoma Responded
to a Single Infusion of Yescarta, with 80 Percent Achieving a
Complete Response --
-- Data Presented in an Oral Session During
the 2020 American Society of Clinical Oncology Annual Meeting
--
Kite, a Gilead Company (Nasdaq: GILD), today announced results
from an interim analysis of ZUMA-5, a global, multicenter,
single-arm, open-label Phase 2 study evaluating Yescarta®
(axicabtagene ciloleucel) in adult patients with relapsed or
refractory indolent (slow growing) non-Hodgkin lymphoma (NHL) after
at least two prior lines of therapy. After a single infusion of
Yescarta, 93 percent of patients (n=96 evaluable for efficacy)
responded, with 80 percent of patients achieving a complete
response (CR) as assessed by an independent review committee. The
data were presented in an oral session during the 2020 American
Society of Clinical Oncology (ASCO) Annual Meeting held from May
29-31 (Abstract #8008). The presentation has also been selected for
a Highlights of the Day session as part of ASCO’s 2020 Virtual
Scientific Program on Saturday, May 30 at 11:30 am ET. The
Highlights sessions recap the most impactful science from the oral
sessions.
Pending results from the primary analysis at 12 months, Kite
plans to submit a supplemental Biologics License Application (sBLA)
to the U.S. Food and Drug Administration (FDA) later this year to
expand the indication for Yescarta. Yescarta has previously been
granted a Breakthrough Therapy Designation (BTD) by the FDA for
relapsed or refractory follicular lymphoma (FL) or marginal zone
lymphoma (MZL) (two types of indolent NHL) after at least two prior
therapies. If approved, Yescarta would become the first and only
chimeric antigen receptor (CAR) T therapy approved for the
treatment of relapsed or refractory indolent NHLs.
“People living with certain indolent non-Hodgkin lymphomas, such
as follicular lymphoma, can experience relapses with increasing
frequency and develop a more aggressive disease over time despite
available treatments,” said Caron A. Jacobson, MD, Medical
Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer
Institute and Assistant Professor of Medicine, Harvard Medical
School. “Thus, the strong overall response and complete response
rates demonstrating the potential of this therapy is extremely
promising for these patients.”
Ninety-five percent of patients with relapsed or refractory FL
(n=80) who had received at least two prior lines of systemic
therapy responded to Yescarta, including 81 percent of patients
achieving a CR and 68 percent of patients in an ongoing response
after at least nine months of follow-up as per independent review
committee assessment. Of patients with relapsed or refractory MZL
(n=16), 81 percent responded to Yescarta, with 75 percent achieving
a CR after at least one month of follow-up as per independent
review committee assessment. With a median follow-up of 15.3 months
in all patients, median duration of response (DOR) was 20.8 months,
median progression-free survival (PFS) was 23.5 months and median
overall survival (OS) was not reached.
In the safety analysis of 140 treated patients with FL or MZL,
Grade 3 or higher cytokine release syndrome (CRS) and neurologic
events occurred in 8 percent and 17 percent of patients,
respectively. There were two Grade 5 adverse events in patients
with FL, including one patient with multisystem organ failure in
the context of CRS related to treatment with Yescarta and one
patient with aortic dissection unrelated to Yescarta treatment. The
primary analysis with 12 months of follow-up is ongoing.
“Yescarta is substantially improving outcomes for people with
certain relapsed and refractory cancers, such as diffuse large
B-cell lymphoma,” said Ken Takeshita, MD, Kite’s Global Head of
Clinical Development. “These results from ZUMA-5 support our
assessment that Yescarta has the potential to provide benefit in
indolent NHL, and we look forward to sharing results from the
primary analysis in patients with relapsed or refractory disease
later this year.”
Yescarta has not been approved by any regulatory agency for the
treatment of indolent non-Hodgkin lymphoma, including follicular
lymphoma or marginal zone lymphoma. Its safety and efficacy have
not been established in these lymphomas.
Yescarta was the first 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 Indolent Non-Hodgkin
Lymphoma
Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are
both forms of indolent non-Hodgkin lymphoma (NHL) in which
malignant tumors slowly grow but can become more aggressive over
time.
FL is the most common form of indolent lymphoma and the second
most common type of lymphoma globally. It accounts for
approximately 22 percent of all lymphomas diagnosed worldwide. MZL
is the third most common lymphoma, accounting for 8 to 12 percent
of all B-cell NHLs.
Despite advances in management and substantial improvements in
long-term survival, patients living with FL have varied outcomes.
Currently, there are no standard of care treatments for relapsed
and refractory FL after two or more lines of therapy, and there are
limited options for the treatment of relapsed or refractory
MZL.
About ZUMA-5
ZUMA-5 is a single-arm, multicenter, open-label Phase 2 study
that aims to enroll up to 160 adult patients (≥18 years old) with
relapsed or refractory iNHL of either follicular lymphoma (FL) or
marginal zone lymphoma (MZL) subtypes, who received at least two
prior lines of systemic therapy, including an anti-CD20 monoclonal
antibody combined with an alkylating agent. The objectives of the
study are to evaluate the efficacy and safety of a single infusion
of Yescarta in this patient population. The primary endpoint of the
trial is objective response rate (ORR) as assessed by an
independent review committee per the 2014 Lugano Classification.
Secondary endpoints include CR rate, DOR, PFS, OS, safety and CAR T
cell and cytokines levels. 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 REMS.
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 REMS 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.YESCARTAREMS.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.
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 submit an sBLA to the FDA to expand the
indication of Yescarta for the treatment of adult patients with
relapsed or refractory iNHL in the anticipated timelines or at all
and the risk that FDA may not approve the sBLA in the anticipated
timelines or at all, and any marketing approvals, if granted, may
have significant limitations on its use. There is also the
possibility of unfavorable results from other ongoing and
additional clinical trials involving Yescarta for the treatment of
relapsed or refractory iNHL and other indications and the
possibility that Kite may be unable to complete such trials in the
currently anticipated timelines or at all. 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, 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.
Yescarta is a trademark of Kite Pharma,
Inc.
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/20200529005008/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Nathan Kaiser, Media (650) 522-1853
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