-- Nine Abstracts, Including Three Oral
Presentations, Highlight Leadership in Hematologic Malignancies and
Early Progress in Solid Tumors --
-- Interim Analysis from Phase 2 Study
Investigating Yescarta® in Indolent Non-Hodgkin Lymphoma and New
Phase 1b Data for Investigational Magrolimab Among Oral
Presentations --
Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company,
today announced the acceptance of nine abstracts, including three
oral presentations across its immuno-oncology research and
development program, during the 2020 American Society of Clinical
Oncology (ASCO) Annual Meeting being held from May 29-31, 2020.
Data at ASCO include abstracts highlighting Kite’s leading cell
therapy portfolio and magrolimab, an investigational anti-CD47
monoclonal antibody developed by Forty Seven, Inc., which was
recently acquired by Gilead.
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“Gilead has a deep commitment to innovation in oncology. Our
colleagues at Kite are driving advances in cell therapy, and our
growing immuno-oncology portfolio at Gilead now includes
magrolimab, which has the potential to bring significant benefit to
patients with certain hematologic malignancies,” said Merdad
Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The
presentations at ASCO underscore the strength of our scientific
approach in immuno-oncology, and we look forward to sharing this
latest research.”
Continuing Scientific Advances in Hematologic
Malignancies
Updated results from a Phase 1b study of magrolimab in patients
with myelodysplactic syndrome (MDS) and acute myeloid leukemia
(AML), including highly under-served AML patients with P53
mutations, will be the focus of an oral presentation (Abstract
#7507). Magrolimab has the potential to be a first-in-class
anti-CD47 antibody based on its mechanism of action and emerging
clinical data.
Additionally, new data building on Kite’s leadership in chimeric
antigen receptor (CAR) T cell therapy include an interim analysis
from the Phase 2 ZUMA-5 study evaluating an investigational use of
Yescarta® (axicabtagene ciloleucel) in patients with relapsed or
refractory indolent non-Hodgkin lymphoma (iNHL). These data will
also be featured in an oral presentation (Abstract #8008). Yescarta
has been granted Breakthrough Therapy Designation (BTD) by the U.S.
Food and Drug Administration (FDA) for relapsed or refractory
follicular lymphoma or marginal zone lymphoma (two subtypes of
iNHL) after at least two prior systemic therapies.
“At Kite, we are committed to advancing science to bring
potentially curative therapies to patients with hematologic
malignancies and other cancers,” said Ken Takeshita, MD, Kite’s
Global Head of Clinical Development. “Our data at ASCO represent
important progress as we work toward this goal.”
Early Progress with Cell Therapy in Solid Tumors
Data focused on T cell receptor (TCR) technology, a promising
approach to solid tumor-directed cell therapy under investigation,
also will be featured in an oral presentation. Results from a Phase
1 clinical trial conducted by the National Cancer Institute (NCI),
as part of a Cooperative Research and Development Agreement (CRADA)
between the Experimental Transplantation and Immunology Branch
(ETIB) of the NCI and Kite, describe the safety and clinical
activity of E7 TCR T cells in patients with highly refractory
metastatic human papillomavirus (HPV)-16 cancers, such as vulvar,
anal, head and neck, and cervical cancer (Abstract #101).
Additionally, Kite has an IND for its own candidate, KITE-439,
based on the NCI E7 TCR, and is currently conducting a Phase 1
study of investigational KITE-439 in patients with relapsed or
refractory HPV-16-positive cancers (Abstract #TPS3149).
Accepted abstracts are as follows:
Area of Focus and Presentation
Number
Abstract Title
Presentations
MDS and AML Abstract #7507 (Oral)*
Tolerability and Efficacy of the
First-in-Class Anti-CD47 Antibody Magrolimab Combined with
Azacitidine in MDS and AML Patients: Phase 1b Results
Non-Hodgkin Lymphoma Abstract #8008
(Oral)*
Interim Analysis of ZUMA-5: A Phase 2
Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with
Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (R/R iNHL)
Solid Tumors Abstract #101 (Oral)* (NCI
study: NCT02858310)
Safety and Clinical Activity of
Gene-engineered T-Cell Therapy Targeting HPV-16 E7 for Epithelial
Cancers
Large B-cell Lymphoma Abstract #8012
(Poster 345)*
Retreatment of Patients with Refractory
Large B-cell Lymphoma with Axicabtagene Ciloleucel (Axi-Cel) in
ZUMA-1
Mantle Cell Lymphoma Abstract #3023
(Poster 87)*
Product Characteristics and
Pharmacological Profile of KTE-X19 in Patients With
Relapsed/Refractory Mantle Cell Lymphoma (MCL) in the Phase 2
Registrational ZUMA-2 Trial
Large B-cell Lymphoma Abstract #3022
(Poster 86)*
Tumor Microenvironment Associated With
Increased Pretreatment Density of Activated PD-1+ LAG-3+/− TIM-3−
CD8+ T Cells Facilitates Clinical Response to Axicabtagene
Ciloleucel (Axi-Cel) in Patients with Large B-cell Lymphoma
Trials-In-Progress
Solid Tumors Abstract #TPS3149 (Poster
213)*
KITE-439: A Phase 1 Study of HPV16 E7 T
Cell Receptor-Engineered T Cells in Patients with
Relapsed/Refractory HPV16-Positive Cancers
Online Publication
Lymphoma (Online only)
Health-Related Quality of Life Burden in
Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma and
Non-Hodgkin’s Lymphoma
MDS and AML (Online only)
Pharmacokinetic-Pharamcodynamic Analysis
and Receptor Occupancy Data to Support Every Other Week Maintenance
Dosing of Magrolimab in Combination with Azacitidine in MDS/AML
Patients
*Presentation will be made available on-demand beginning Friday,
May 29 at 8:00 am ET.
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
(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.
The use of Yescarta in relapsed or refractory iNHL is
investigational and not approved globally. It’s efficacy and safety
have not been established in this indication. Magrolimab, KTE-X19
and KITE-439 are investigational and not approved anywhere
globally. Their efficacy and safety have not been established. More
information about clinical trials with magrolimab, KTE-X19 and
KITE-439 is available at www.clinicaltrials.gov.
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 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.
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.
Gilead and Kite Forward-Looking
Statements
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 studies involving Yescarta, magrolimab, KTE-X19
and KITE-439. 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 and Axi-Cel are trademarks of Kite
Pharma, Inc.
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. For more information
on Kite, please visit the company’s website at www.kitepharma.com.
Follow Kite on social media on Twitter (@KitePharma) and
LinkedIn.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200513005577/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Nathan Kaiser, Media (650) 522-1853
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