-- 16 Abstracts, Including Three Oral
Presentations, Highlight Breadth of Company’s Innovation in
Immuno-Oncology for Patients with Blood Cancers --
-- Kite Data Highlight Yescarta® Long-Term
Efficacy in Relapsed/Refractory Large B-Cell Lymphoma, its
Potential as An Earlier Line of Therapy in DLBCL, as well as
Results in Other Cancers, and One-Year Follow-up Results for
Tecartus™ in Relapsed Mantle Cell Lymphoma --
-- Magrolimab Demonstrates Continued
Response Rates in Updated Results of Phase 1b Study of Acute
Myeloid Leukemia Patients, Including Those with TP53 Mutation
--
Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company,
today announced that 16 abstracts, including three oral
presentations from the companies’ combined immuno-oncology research
and development programs, have been accepted for presentation at
the 62nd American Society of Hematology (ASH) Annual Meeting and
Exposition. The meeting, which is being held virtually on December
5-8, 2020, will feature presentations on Yescarta® (axicabtagene
ciloleucel), Tecartus™ (brexucabtagene autoleucel, KTE-X19) and
other ongoing research from Kite’s chimeric antigen receptor (CAR)
T cell therapy development program, as well as magrolimab, Gilead’s
first-in-class, investigational anti-CD47 monoclonal antibody.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20201105005130/en/
“The evidence supporting our innovation in hematologic
malignancies continues to grow, providing assurance of the lasting
and positive impact our diverse oncology pipeline could achieve
over time,” said Merdad Parsey, MD, PhD, Chief Medical Officer,
Gilead Sciences. “We continue to see broad potential across our
oncology portfolio – anchored by Kite in cell therapy and Gilead’s
anti-CD47 monoclonal antibody – to transform care for patients with
hard-to-treat blood cancers.”
New Long-Term Efficacy Data and the Potential of CAR T
Therapy for More Patients
Building on three-year data presented at ASH 2019, overall
survival results at four years from the pivotal ZUMA-1 trial of
Yescarta in patients with refractory large B-cell lymphoma will be
presented (Abstract #1187). Additionally, new data include one-year
follow-up results from the ZUMA-2 study evaluating KTE-X19 in
relapsed or refractory mantle cell lymphoma (Abstract #1120), as
well as several studies evaluating the potential of Yescarta in new
indications include an interim analysis of ZUMA-12 in first-line
large B-cell lymphoma among patients with high-risk features
(Abstract #405) and the ZUMA-5 primary analysis in relapsed or
refractory indolent non-Hodgkin lymphoma (NHL), including
follicular lymphoma (FL) and marginal zone lymphoma (MZL; Abstract
#700).
Data from the ZUMA-5 primary analysis form the basis for the
supplemental Biologics License Application (sBLA) for Yescarta
currently under review by the U.S. Food & Drug Administration
(FDA). Yescarta has previously been granted a Breakthrough Therapy
Designation by the FDA for relapsed or refractory FL or MZL after
at least two prior therapies and has been granted a Priority Review
with a target action date, under the Prescription Drug User Fee Act
(PDUFA), of March 5, 2021.
“Our data at ASH build on the established strengths of our CAR T
franchise, including practice-changing potential in new cancers,”
said Ken Takeshita, MD, Kite’s Global Head of Clinical Development.
“As we become the first company to present four-year CAR T data
from a pivotal study in large B-cell lymphoma and continue to
expand our leadership in cell therapy across different hematologic
malignancies and into earlier lines of therapy, we remain committed
to bringing the benefits of cell therapies to as many patients as
possible.”
Harnessing Potential First-in-Class Anti-CD47 Antibody in
Difficult-to-Treat Malignancies
Researchers will give an oral presentation of updated results
from the Phase 1b study of magrolimab in patients with
previously-untreated acute myeloid leukemia (AML) who cannot
undergo treatment with intensive chemotherapy, including patients
with TP53-mutant AML (Abstract #330). The FDA recently assigned
Breakthrough Designation to magrolimab, in combination with
azacitidine for the treatment of adult patients with
newly-diagnosed MDS including intermediate-, high-, or very
high-risk tumor types to expedite the development and regulatory
review of this investigational treatment. Magrolimab also received
PRIME Designation for treatment of MDS from the European Medicines
Agency (EMA).
Dates and times for all accepted abstracts are as follows:
Area of Focus, Presentation
Number and Date/Time
Abstract Title
Oral Presentations
Acute Myeloid Leukemia
Abstract #330
Sunday, Dec 6
(12:30pm ET / 9:30am PT)
The First-in-Class Anti-CD47 Antibody
Magrolimab Combined with Azacitidine Is Well-Tolerated and
Effective in AML Patients: Phase 1b Results
Large B-cell Lymphoma
Abstract #405
Sunday, Dec 6
(4:15pm ET / 1:15pm PT)
Interim Analysis of ZUMA-12: A Phase 2
Study of Axicabtagene Ciloleucel (Axi-Cel) as First-Line Therapy in
Patients (Pts) with High-Risk Large B Cell Lymphoma (LBCL)
Non-Hodgkin Lymphoma Abstract #700
Monday, Dec 7
(4:30pm ET / 1:30pm PT)
Primary Analysis of ZUMA-5: A Phase 2
Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients With
Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL)
Poster Presentations
Follicular Lymphoma
Abstract #1145
Saturday, Dec 5
(10:00am ET / 7:00am PT)
Safety Profile of Idelalisib in Patients
with Refractory Follicular Lymphoma: Interim Analysis of a
Noninterventional Study
Large B-cell Lymphoma Abstract #1187
Saturday, Dec 5
(10:00am ET / 7:00am PT)
Long-Term Survival and Gradual Recovery of
B Cells in Patients With Refractory Large B Cell Lymphoma Treated
With Axicabtagene Ciloleucel (Axi-Cel)
Large B-cell Lymphoma Abstract #2100
Sunday, Dec 6
(10:00am ET / 7:00am PT)
Outcomes of Patients (Pts) in ZUMA-9, A
Multicenter, Open-Label Study of Axicabtagene Ciloleucel (Axi-Cel)
in Relapsed/Refractory Large B Cell Lymphoma (R/R LBCL) for
Expanded Access and Commercial Out-of-Specification (OOS)
Product
Large B-cell Lymphoma
Abstract #1224
Saturday, Dec 5
(10:00am ET / 7:00am PT)
The First Retrospective Commercial
Claims-Based Analysis of CAR T Treated Patients With Relapsed or
Refractory Large B-Cell Lymphoma (R/R LBCL)
Large B-cell Lymphoma
Abstract #2500
Sunday, Dec 6
(10:00am ET / 7:00am PT)
Cost and Healthcare Utilization in
Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Real-World
Analysis of Medicare Beneficiaries Receiving Chimeric Antigen
Receptor T-Cell Vs. Autologous and Allogeneic Hematopoietic Stem
Cell Transplants
Large B-cell Lymphoma
Abstract #2548
Sunday, Dec 6
(10:00am ET / 7:00am PT)
Burden of Illness and Outcomes in the 2nd
Line Treatment of Large B-Cell Lymphoma: A Real-World Comparison of
Medicare Beneficiaries with and without Stem Cell Transplants
Large B-cell Lymphoma
Abstract #1646
Saturday, Dec 5
(10:00am ET / 7:00am PT)
Lines of Therapy in Patients with Relapsed
or Refractory Large B-Cell Lymphoma and Stem Cell
Transplant-Intended Treatment
Mantle Cell Lymphoma
Abstract #1120
Saturday, Dec 5
(10:00am ET / 7:00am PT)
One-Year Follow-Up of ZUMA-2, the
Multicenter, Registrational Study of KTE-X19 in Patients With
Relapsed/Refractory Mantle Cell Lymphoma
Mantle Cell Lymphoma
Abstract #1126
Saturday, Dec 5
(10:00am ET / 7:00am PT)
Pharmacological Profile and Clinical
Outcomes of KTE-X19 by Prior Bruton Tyrosine Kinase Inhibitors
(BTKi) Exposure or Mantle Cell Lymphoma (MCL) Morphology in
Patients With Relapsed/Refractory (R/R) MCL in the ZUMA-2 Trial
Non-Hodgkin Lymphoma
Abstract #2036
Sunday, Dec 6
(10:00am ET / 7:00am PT)
Retreatment With Axicabtagene Ciloleucel
(Axi-Cel) in Patients With Relapsed/Refractory Indolent Non-Hodgkin
Lymphoma in ZUMA-5
Trials-In-Progress
Acute Lymphoblastic Leukemia &
Non-Hodgkin Lymphoma
Abstract #1896
Sunday, Dec 6
(10:00am ET / 7:00am PT)
ZUMA-4: A Phase 1/2 Multicenter Study of
KTE-X19 in Pediatric and Adolescent Patients With
Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia or
Non-Hodgkin Lymphoma
Large B-cell Lymphoma
Abstract #2103
Sunday, Dec 6
(10:00am ET / 7:00am PT)
ZUMA-19: A Phase 1/2 Multicenter Study of
Lenzilumab Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients
(Pts) With Relapsed or Refractory Large B Cell Lymphoma (R/R
LBCL)
Online Publication
Follicular Lymphoma
Efficacy Outcomes of Treatments for Double
Relapsed/Refractory Follicular Lymphoma (R/R FL): A Systematic
Literature Review
For more information, including a complete list of abstract
titles at the meeting, please visit:
https://ash.confex.com/ash/2020/webprogram/start.html.
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, 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. In July, Tecartus became the first CAR T
cell therapy to receive accelerated approval from the FDA for the
treatment of relapsed or refractory mantle cell lymphoma, based on
overall response rate and durability of response. Continued
approval for this indication may be contingent upon additional data
from a confirmatory trial. The U.S. Prescribing Information for
Yescarta and Tecartus each have BOXED WARNINGS for the risks of CRS
and neurologic toxicities, and Yescarta and Tecartus are each
approved with a risk evaluation and mitigation strategy (REMS) due
to these risks; see below for Important Safety Information.
The uses of Yescarta in relapsed or refractory FL or MZL or as a
first-line treatment for patients with large B-cell lymphoma and
high-risk genetics are investigational and not approved anywhere
globally. Its efficacy and safety have not been established for
these indications.
Magrolimab is investigational and not approved anywhere
globally. Its efficacy and safety have not been established. More
information about clinical trials with magrolimab is available at
www.clinicaltrials.gov.
ABOUT MAGROLIMAB
Magrolimab is a first-in-class, investigational monoclonal
antibody against CD47 and macrophage checkpoint inhibitor that is
designed to interfere with recognition of CD47 by the SIRPα
receptor on macrophages, thus blocking the “don't eat me” signal
used by cancer cells to avoid being ingested by macrophages.
Magrolimab is being developed in several hematologic and solid
tumor malignancies, including MDS. Magrolimab has been granted Fast
Track Designation for the treatment of MDS, AML, DLBCL and FL.
Magrolimab has also been granted Orphan Drug Designation by the FDA
and EMA for treatment of MDS and AML.
About Yescarta
Yescarta is a CD19-directed genetically modified autologous T
cell immunotherapy indicated for the treatment of adult patients
with relapsed or refractory large B-cell lymphoma after two or more
lines of systemic therapy, including DLBCL not otherwise specified,
primary mediastinal large B-cell lymphoma, high grade B-cell
lymphoma, and DLBCL arising from follicular lymphoma.
Limitation of Use: Yescarta
is not indicated for the treatment of patients with primary central
nervous system lymphoma.
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 accompanying full Prescribing Information, including
BOXED WARNING and Medication Guide.
About Tecartus
Tecartus is a CD19-directed genetically modified autologous T
cell immunotherapy indicated for the treatment of adult patients
with relapsed or refractory mantle cell lymphoma (MCL).
This indication is approved under accelerated approval based on
overall response rate and durability of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial.
U.S. Important Safety Information for
Tecartus
BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC
TOXICITIES
- Cytokine Release Syndrome (CRS), including life-threatening
reactions, occurred in patients receiving Tecartus. Do not
administer Tecartus to patients with active infection or
inflammatory disorders. Treat severe or life-threatening CRS with
tocilizumab or tocilizumab and corticosteroids.
- Neurologic toxicities, including life-threatening reactions,
occurred in patients receiving Tecartus, including concurrently
with CRS or after CRS resolution. Monitor for neurologic toxicities
after treatment with Tecartus. Provide supportive care and/or
corticosteroids as needed.
- Tecartus 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), including
life-threatening reactions, occurred following treatment with
Tecartus. In ZUMA-2, CRS occurred in 91% (75/82) of patients
receiving Tecartus, including ≥ Grade 3 CRS in 18% of patients.
Among the patients who died after receiving Tecartus, one had a
fatal CRS event. The median time to onset of CRS was three days
(range: 1 to 13 days) and the median duration of CRS was ten days
(range: 1 to 50 days). Among patients with CRS, key manifestations
(>10%) included fever (99%), hypotension (60%), hypoxia (37%),
chills (33%), tachycardia (37%), headache (24%), fatigue (19%),
nausea (13%), alanine aminotransferase increased (13%), aspartate
aminotransferase increased (12%), and diarrhea (11%). Serious
events associated with CRS included hypotension, fever, hypoxia,
acute kidney injury, and tachycardia.
Ensure that a minimum of two doses of tocilizumab are available
for each patient prior to infusion of Tecartus. Following infusion,
monitor patients for signs and symptoms of CRS daily for at least
seven days at the certified healthcare facility, and for four 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, including those that were
life-threatening, occurred following treatment with Tecartus. In
ZUMA-2, neurologic events occurred in 81% of patients, 37% of whom
experienced Grade ≥3 adverse reactions. The median time to onset
for neurologic events was six days (range: 1 to 32 days).
Neurologic events resolved for 52 out of 66 (79%) patients with a
median duration of 21 days (range: 2 to 454 days). Three patients
had ongoing neurologic events at the time of death, including one
patient with serious encephalopathy. The remaining unresolved
neurologic events were either Grade 1 or Grade 2. Fifty-four (66%)
patients experienced CRS by the onset of neurological events. Five
(6%) patients did not experience CRS with neurologic events and
eight patients (10%) developed neurological events after the
resolution of CRS. 85% of all treated patients experienced the
first CRS or neurological event within the first seven days after
Tecartus infusion.
The most common neurologic events (>10%) included
encephalopathy (51%), headache (35%), tremor (38%), aphasia (23%),
and delirium (16%). Serious events including encephalopathy,
aphasia, and seizures occurred.
Monitor patients daily for at least seven days at the certified
healthcare facility and for four weeks following infusion for signs
and symptoms of neurologic toxicities and treat promptly.
REMS Program: Because of the risk of CRS and neurologic
toxicities, Tecartus is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
Yescarta and Tecartus REMS Program which requires that:
- Healthcare facilities that dispense and administer Tecartus
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 two doses of tocilizumab
are available for each patient for infusion within two hours after
Tecartus infusion, if needed for treatment of CRS.
- Certified healthcare facilities must ensure that healthcare
providers who prescribe, dispense, or administer Tecartus are
trained in the management of CRS and neurologic toxicities. Further
information is available at www.YescartaTecartusREMS.com or
1-844-454-KITE (5483).
Hypersensitivity Reactions: Serious hypersensitivity
reactions, including anaphylaxis, may occur due to dimethyl
sulfoxide (DMSO) or residual gentamicin in Tecartus.
Severe Infections: Severe or life-threatening infections
occurred in patients after Tecartus infusion. In ZUMA-2, infections
(all grades) occurred in 56% of patients. Grade 3 or higher
infections, including bacterial, viral, and fungal infections,
occurred in 30% of patients. Tecartus 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
antimicrobials according to local guidelines.
Febrile neutropenia was observed in 6% of patients after
Tecartus infusion 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.
Viral Reactivation
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 Tecartus
infusion. In ZUMA-2, Grade ≥3 cytopenias not resolved by Day 30
following Tecartus infusion occurred in 55% of patients and
included thrombocytopenia (38%), neutropenia (37%), and anemia
(17%). Monitor blood counts after infusion.
Hypogammaglobulinemia and B-cell aplasia can occur in
patients receiving treatment with Tecartus. In ZUMA-2,
hypogammaglobulinemia occurred in 16% of patients. Monitor
immunoglobulin levels after treatment with Tecartus and manage
using infection precautions, antibiotic prophylaxis, and
immunoglobulin replacement. The safety of immunization with live
viral vaccines during or following Tecartus treatment has not been
studied. Vaccination with live virus vaccines is not recommended
for at least six weeks prior to the start of lymphodepleting
chemotherapy, during treatment, and until immune recovery following
treatment with Tecartus.
Secondary Malignancies may develop. Monitor life-long for
secondary malignancies. In the event that it 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 Tecartus
infusion. Advise patients to refrain from driving and engaging in
hazardous activities, such as operating heavy or potentially
dangerous machinery, during this period.
Adverse Reactions: The most common adverse reactions
(incidence ≥ 20%) were pyrexia, CRS, hypotension, encephalopathy,
fatigue, tachycardia, arrhythmia, infection – pathogen unspecified,
chills, hypoxia, cough, tremor, musculoskeletal pain, headache,
nausea, edema, motor dysfunction, constipation, diarrhea, decreased
appetite, dyspnea, rash, insomnia, pleural effusion, and aphasia.
Serious adverse reactions occurred in 66% of patients. The most
common serious adverse reactions (> 2%) were encephalopathy,
pyrexia, infection – pathogen unspecified, CRS, hypoxia, aphasia,
renal insufficiency, pleural effusion, respiratory failure,
bacterial infections, dyspnea, fatigue, arrhythmia, tachycardia,
and viral infections.
Please see full Prescribing Information, including BOXED
WARNING and Medication Guide.
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, 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.
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, Tecartus and
magrolimab and the possibility that Gilead and Kite may be unable
to initiate or complete one or more of such studies in the
currently anticipated timelines or at all. There is also the risk
that the FDA may not approve Yescarta for the treatment of relapsed
or refractory FL or MZL after at least two prior therapies in the
anticipated timelines or at all, and any marketing approvals if
granted, may have significant limitations on its use. Further, it
is possible that Gilead may make a strategic decision to
discontinue development of magrolimab or that the FDA and other
regulatory agencies may not approve magrolimab for the treatment of
MDS and other indications, and any marketing approvals, if granted,
may have significant limitations on its use. 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, are available at www.kitepharma.com
and www.gilead.com.
Kite, the Kite logo, Yescarta, and Tecartus are
trademarks of Kite Pharma, Inc. GILEAD is a trademark of Gilead
Sciences, 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/20201105005130/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Nathan Kaiser, Kite Media (650) 522-1853
Marian Cutler, Gilead Media (973) 517-0519
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