– Eight Presentations on Yescarta® and
Tecartus® Advance Kite’s Cell Therapy Leadership –
– New Data Highlight Magrolimab’s Potential
to Alter the Tumor Microenvironment –
Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company,
will present 17 abstracts from its industry-leading cell therapy
portfolio and growing blood cancer pipeline at the upcoming 2023
European Hematology Association (EHA) Annual Congress being held in
Frankfurt, Germany, June 8-11, and virtually June 14-15.
Real-World Evidence and Multi-Year Follow-Up of Pivotal
Studies Reinforce Confidence in CAR T
Four real-world evidence presentations include Yescarta®
(axicabtagene ciloleucel) vein-to-vein time in large B-cell
lymphoma (LBCL) and early outcomes in follicular lymphoma (FL).
Presentations for Tecartus® (brexucabtagene autoleucel) include
outcomes in relapsed/refractory (R/R) mantle cell lymphoma (MCL)
and long-term results from the Phase 3 ZUMA-3 trial in R/R B-cell
acute lymphoblastic leukemia (ALL). Additional data to be presented
include trials-in-progress on the use of Yescarta in FL versus
standard of care (ZUMA-22), as a first-line treatment in high-risk
LBCL (ZUMA-23) and in the outpatient setting (ZUMA-24).
“The presentation of longer-term follow-up data from our pivotal
studies and real-world evidence reinforce the potential of cell
therapy across different blood cancers, lines of treatment and
settings,” said Frank Neumann, MD, PhD, Senior Vice President,
Global Head of Clinical Development, Kite. “We are committed to
providing ongoing insights to clinicians to support the management
of patients living with difficult-to-treat blood cancers who, with
few treatments currently available, face a poor prognosis.”
Magrolimab Demonstrates Potential to Improve Bone Marrow
Function
Gilead will highlight data showing magrolimab’s potential effect
on the tumor microenvironment to improve bone marrow function in
patients with acute myeloid leukemia (AML) and higher-risk
myelodysplastic syndrome (HR-MDS). Other data include efficacy and
safety information, healthcare resource use in patients with AML
and MDS, and proof-of-concept of magrolimab on calreticulin in
myelofibrosis CD34-positive cells.
“Our data at EHA demonstrate the growing breadth and promise of
our development program across many different blood cancers,” said
Carol O’Hear, MD, Vice President, Clinical Development, Gilead
Oncology. “Important results from our CAR T-cell therapies and new
data for magrolimab continue to drive innovation within our
pipeline and reinforce our commitment to addressing unmet needs
within hematology.”
At EHA, Gilead and Kite Oncology will present the latest data
for investigational and approved blood cancer therapies including
(all times CEST):
Tumor Type
Abstract Title
Acute Myeloid Leukemia and Higher-Risk
Myelodysplastic Syndromes
Abstract #P699
Date: June 9
Time: 6:00p.m.–7:00p.m. CEST
Magrolimab Alters the Tumor
Microenvironment to Improve Bone Marrow Functions in Patients with
Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic
Syndromes (HR-MDS)
Abstract #P746
Date: June 9
Time: 6:00p.m.–7:00p.m. CEST
Real-World Analysis of a Large Electronic
Medical Record Database of Patients With Higher-Risk
Myelodysplastic Syndromes (HR-MDS): Treatment Profiles, Clinical
Effectiveness, and Key Adverse Events
Abstract #P1003
Date: June 9
Time: 6:00p.m.–7:00p.m. CEST
Ruxolitinib and Magrolimab increases
Calreticulin in Myelofibrosis CD34+ Cells In Vitro: Proof of
Concept for Combination Therapy
Abstract #PB2008
Online Publication Only
Incidence of Drug-Induced Myelosuppression
and Associated Adverse Events, Quality of Life, and Medical
Resource use in Myelodysplastic Syndromes and Acute Myeloid
Leukemia
Abstract #PB1888
Online Publication Only
Trial in Progress: Phase 1b/2 Study of
Pivekimab Sunirine (PVEK, IMGN632) in Combination with
Venetoclax/Azacitidine or Magrolimab for Patients with
CD123-Positive Acute Myeloid Leukemia (AML)
Abstract #PB2021
Online Publication Only
Phase 2 Study of Oral
Decitabine/Cedazuridine in Combination With Magrolimab For
Previously Untreated Subjects With Intermediate to Very High-risk
Myelodysplastic Syndromes (MDS)
Follicular Lymphoma
Abstract #S223
Date: June 9
Time: 3:30p.m.–3:45p.m. CEST
Real-world Early Outcomes of Axicabtagene
Ciloleucel for Relapsed or Refractory Follicular Lymphoma
Abstract #P1107
Date: June 9
Time: 6:00p.m.–7:00p.m. CEST
ZUMA-22: A Phase 3, Randomized Controlled
Study of Axicabtagene Ciloleucel Versus Standard-of-Care Therapy in
Patients with Relapsed or Refractory Follicular Lymphoma
B-Cell Lymphoma
Abstract #P1204
Date: June 9
Time: 6:00p.m.–7:00p.m. CEST
Axicabtagene Ciloleucel Vein-to-Vein Time
in Trial or Real-World Settings vs Other CAR T-cell Therapies for
Relapsed/Refractory Large B-cell Lymphoma: A Systematic Literature
Review and Meta-Analysis
Abstract #PB2319
Online Publication Only
ZUMA-23: A Global Phase 3, Randomized
Controlled Study of Axicabtagene Ciloleucel Versus Standard of Care
as First-Line Therapy in Patients with High-Risk Large B-Cell
Lymphoma
Abstract #PB2346
Online Publication Only
ZUMA-24: A Phase 2, Open-Label,
Multicenter Study of Axicabtagene Ciloleucel in Patients with
Relapse/Refractory Large B-Cell Lymphoma Given with Corticosteroids
in the Outpatient Setting
Abstract #PB2306
Online Publication Only
Real-World First-Line Treatment and
Outcomes Among Patients with High-Risk Diffuse Large B-Cell
Lymphoma Treated with Standard Of Care
Abstract #P1694
Date: June 9
Time: 6:00p.m.–7:00p.m. CEST
Cost-Effectiveness of Axicabtagene
Ciloleucel Vs. Tisagenlecleucel for the Treatment of
Relapsed/Refractory large B-Cell Lymphoma: Updated survival results
from the ZUMA-1 and Juliet Trials
Acute Lymphoblastic Leukemia
Abstract #P367
Date: June 9
Time: 6:00p.m.–7:00p.m. CEST
Long-Term Outcomes of Adults with Relapsed
or Refractory B-Cell Acute Lymphoblastic Leukemia Treated with
Brexucabtagene Autoleucel in ZUMA-3 by age, Prior Therapies and
Subsequent Transplant
Mantle Cell Lymphoma
Abstract #S220
Date: June 9
Time: 2:45p.m.–3:00p.m. CEST
Real-World Outcomes of Brexucabtagene
Autoleucel (brexu-cel) for Relapsed or Refractory Mantle Cell
Lymphoma: A CIBMTR Subgroup Analysis by Prior Treatment
ALYCANTE (sponsored by
LYSA/LYSARC)
Abstract #S233
Date: June 10
Time: 5:15p.m.–5:30p.m. CEST
Axicabtagene Ciloleucel as Second-Line
Therapy for Large B-cell Lymphoma in Transplant-Ineligible
Patients: Final Analysis of ALYCANTE, a Phase 2 Lysa study
Abstract #P1123
Date: June 9
Time: 6:00p.m.–7:00p.m. CEST
Early ctDNA Clearance After CAR T-cell
Infusion Predicts Outcome in Patients with Large B-cell Lymphoma:
Results from ALYCANTE, a Phase 2 Lysa study
Magrolimab is investigational and is not approved by the U.S.
Food and Drug Administration or any other regulatory authority. Its
safety and efficacy have not been established.
About Yescarta
Please see full FDA Prescribing Information, including BOXED
WARNING and Medication Guide.
YESCARTA is a CD19-directed genetically modified autologous T
cell immunotherapy indicated for the treatment of:
- Adult patients with large B-cell lymphoma that is refractory to
first-line chemoimmunotherapy or that relapses within 12 months of
first-line chemoimmunotherapy.
- 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, high grade B-cell
lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: YESCARTA is not
indicated for the treatment of patients with primary central
nervous system lymphoma.
- Adult patients with relapsed or refractory follicular lymphoma
(FL) after two or more lines of systemic therapy. This indication
is approved under accelerated approval based on response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trial(s).
U.S. IMPORTANT SAFETY INFORMATION
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)
CRS, including fatal or life-threatening reactions, occurred.
CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma
(NHL), including ≥ Grade 3 in 9%. CRS occurred in 93% (256/276) of
patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in
9%. Among patients with LBCL who died after receiving YESCARTA, 4
had ongoing CRS events at the time of death. For patients with LBCL
in ZUMA-1, the median time to onset of CRS was 2 days following
infusion (range: 1-12 days) and the median duration was 7 days
(range: 2-58 days). For patients with LBCL in ZUMA-7, the median
time to onset of CRS was 3 days following infusion (range: 1-10
days) and the median duration was 7 days (range: 2-43 days). CRS
occurred in 84% (123/146) of patients with indolent non-Hodgkin
lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 in 8%. Among
patients with iNHL who died after receiving YESCARTA, 1 patient had
an ongoing CRS event at the time of death. The median time to onset
of CRS was 4 days (range: 1-20 days) and median duration was 6 days
(range: 1-27 days) for patients with iNHL.
Key manifestations of CRS (≥ 10%) in all patients combined
included fever (85%), hypotension (40%), tachycardia (32%), chills
(22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious
events that may be associated with CRS include cardiac arrhythmias
(including atrial fibrillation and ventricular tachycardia), renal
insufficiency, cardiac failure, respiratory failure, cardiac
arrest, capillary leak syndrome, multi-organ failure, and
hemophagocytic lymphohistiocytosis/macrophage activation
syndrome.
The impact of tocilizumab and/or corticosteroids on the
incidence and severity of CRS was assessed in 2 subsequent cohorts
of LBCL patients in ZUMA-1. Among patients who received tocilizumab
and/or corticosteroids for ongoing Grade 1 events, CRS occurred in
93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients
experienced a Grade 4 or 5 event. The median time to onset of CRS
was 2 days (range: 1-8 days) and the median duration of CRS was 7
days (range: 2-16 days). Prophylactic treatment with
corticosteroids was administered to a cohort of 39 patients for 3
days beginning on the day of infusion of YESCARTA. Thirty-one of
the 39 patients (79%) developed CRS and were managed with
tocilizumab and/or therapeutic doses of corticosteroids with no
patients developing ≥ Grade 3 CRS. The median time to onset of CRS
was 5 days (range: 1-15 days) and the median duration of CRS was 4
days (range: 1-10 days). Although there is no known mechanistic
explanation, consider the risk and benefits of prophylactic
corticosteroids in the context of pre-existing comorbidities for
the individual patient and the potential for the risk of Grade 4
and prolonged neurologic toxicities.
Ensure that 2 doses of tocilizumab are available prior to
YESCARTA 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
Neurologic toxicities (including immune effector cell-associated
neurotoxicity syndrome) that were fatal or life-threatening
occurred. Neurologic toxicities occurred in 78% (330/422) of all
patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%.
Neurologic toxicities occurred in 87% (94/108) of patients with
LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of
patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to
onset was 4 days (range: 1-43 days) and the median duration was 17
days for patients with LBCL in ZUMA-1. The median time to onset for
neurologic toxicity was 5 days (range: 1-133 days) and median
duration was 15 days in patients with LBCL in ZUMA-7. Neurologic
toxicities occurred in 77% (112/146) of patients with iNHL,
including ≥ Grade 3 in 21%. The median time to onset was 6 days
(range: 1-79 days) and the median duration was 16 days.
Ninety-eight percent of all neurologic toxicities in patients with
LBCL and 99% of all neurologic toxicities in patients with iNHL
occurred within the first 8 weeks of YESCARTA infusion. Neurologic
toxicities occurred within the first 7 days of infusion for 87% of
affected patients with LBCL and 74% of affected patients with iNHL.
The most common neurologic toxicities (≥ 10%) in all patients
combined included encephalopathy (50%), headache (43%), tremor
(29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia
(10%). Prolonged encephalopathy lasting up to 173 days was noted.
Serious events, including aphasia, leukoencephalopathy, dysarthria,
lethargy, and seizures occurred. Fatal and serious cases of
cerebral edema and encephalopathy, including late-onset
encephalopathy, have occurred.
The impact of tocilizumab and/or corticosteroids on the
incidence and severity of neurologic toxicities was assessed in 2
subsequent cohorts of LBCL patients in ZUMA-1. Among patients who
received corticosteroids at the onset of Grade 1 toxicities,
neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had
Grade 3 neurologic toxicities; no patients experienced a Grade 4 or
5 event. The median time to onset of neurologic toxicities was 6
days (range: 1-93 days) with a median duration of 8 days (range:
1-144 days). Prophylactic treatment with corticosteroids was
administered to a cohort of 39 patients for 3 days beginning on the
day of infusion of YESCARTA. Of those patients, 85% (33/39)
developed neurologic toxicities, 8% (3/39) developed Grade 3, and
5% (2/39) developed Grade 4 neurologic toxicities. The median time
to onset of neurologic toxicities was 6 days (range: 1-274 days)
with a median duration of 12 days (range: 1-107 days). Prophylactic
corticosteroids for management of CRS and neurologic toxicities may
result in higher grade of neurologic toxicities or prolongation of
neurologic toxicities, delay the onset and decrease the duration of
CRS.
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 45% of patients with NHL. ≥ Grade 3 infections
occurred in 17% of patients, including ≥ Grade 3 infections with an
unspecified pathogen in 12%, bacterial infections in 5%, viral
infections in 3%, and fungal infections in 1%. 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 antimicrobials according to local
guidelines.
Febrile neutropenia was observed in 36% of all patients with NHL
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.
In immunosuppressed patients, including those who have received
YESCARTA, life-threatening and fatal opportunistic infections
including disseminated fungal infections (e.g., candida sepsis and
aspergillus infections) and viral reactivation (e.g., human herpes
virus-6 [HHV-6] encephalitis and JC virus progressive multifocal
leukoencephalopathy [PML]) have been reported. The possibility of
HHV-6 encephalitis and PML should be considered in immunosuppressed
patients with neurologic events and appropriate diagnostic
evaluations should be performed.
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, including
YESCARTA. 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 39% of all patients with NHL and included neutropenia
(33%), thrombocytopenia (13%), and anemia (8%). Monitor blood
counts after infusion.
HYPOGAMMAGLOBULINEMIA
B-cell aplasia and hypogammaglobulinemia can occur.
Hypogammaglobulinemia was reported as an adverse reaction in 14% of
all patients with NHL. 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
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 non-laboratory adverse reactions (incidence ≥
20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue,
hypotension, encephalopathy, tachycardia, diarrhea, headache,
musculoskeletal pain, nausea, febrile neutropenia, chills, cough,
infection with unspecified pathogen, dizziness, tremor, decreased
appetite, edema, hypoxia, abdominal pain, aphasia, constipation,
and vomiting.
The most common adverse reactions (incidence ≥ 20%) in patients
with LBCL in ZUMA-1 included CRS, fever, hypotension,
encephalopathy, tachycardia, fatigue, headache, decreased appetite,
chills, diarrhea, febrile neutropenia, infections with pathogen
unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness,
constipation, and cardiac arrhythmias.
The most common non-laboratory adverse reactions (incidence ≥
20%) in patients with iNHL in ZUMA-5 included fever, CRS,
hypotension, encephalopathy, fatigue, headache, infections with
pathogen unspecified, tachycardia, febrile neutropenia,
musculoskeletal pain, nausea, tremor, chills, diarrhea,
constipation, decreased appetite, cough, vomiting, hypoxia,
arrhythmia, and dizziness.
About Tecartus
Please see full FDA Prescribing Information, including BOXED
WARNING and Medication Guide.
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.
- Adult patients with relapsed or refractory B-cell precursor
acute lymphoblastic leukemia (ALL).
U.S. IMPORTANT SAFETY INFORMATION
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, the key
manifestations (>10%) were similar in MCL and ALL and included
fever (93%), hypotension (62%), tachycardia (59%), chills (32%),
hypoxia (31%), headache (21%), fatigue (20%), and nausea (13%).
Serious events associated with CRS included hypotension, fever,
hypoxia, tachycardia, and dyspnea.
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 Events, including those that were fatal or
life-threatening, occurred following treatment with Tecartus.
Neurologic events occurred in 81% (66/82) of patients with MCL,
including ≥ Grade 3 in 37% of patients. The median time to onset
for neurologic events was six days (range: 1 to 32 days) with a
median duration of 21 days (range: 2 to 454 days) in patients with
MCL. Neurologic events occurred in 87% (68/78) of patients with
ALL, including ≥ Grade 3 in 35% of patients. The median time to
onset for neurologic events was seven days (range: 1 to 51 days)
with a median duration of 15 days (range: 1 to 397 days) in
patients with ALL. For patients with MCL, 54 (66%) patients
experienced CRS before 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. Neurologic events resolved for 119 out of 134 (89%)
patients treated with Tecartus. Nine patients (three patients with
MCL and six patients with ALL) had ongoing neurologic events at the
time of death. For patients with ALL, neurologic events occurred
before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of
patients; respectively. Three patients (4%) had neurologic events
without CRS. The onset of neurologic events can be concurrent with
CRS, following resolution of CRS or in the absence of CRS.
The most common neurologic events (>10%) were similar in MCL
and ALL and included encephalopathy (57%), headache (37%), tremor
(34%), confusional state (26%), aphasia (23%), delirium (17%),
dizziness (15%), anxiety (14%), and agitation (12%). Serious events
including encephalopathy, aphasia, confusional state, and seizures
occurred after treatment with Tecartus.
Monitor patients daily for at least seven days for patients with
MCL and at least 14 days for patients with ALL 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. Infections (all
grades) occurred in 56% (46/82) of patients with MCL and 44%
(34/78) of patients with ALL. Grade 3 or higher infections,
including bacterial, viral, and fungal infections, occurred in 30%
of patients with ALL and MCL. Tecartus should not be administered
to patients with clinically significant active systemic infections.
Monitor patients for signs and symptoms of infection before and
after Tecartus infusion and treat appropriately. Administer
prophylactic antimicrobials according to local guidelines.
Febrile neutropenia was observed in 6% of patients with MCL and
35% of patients with ALL after Tecartus infusion and may be
concurrent with CRS. The febrile neutropenia in 27 (35%) of
patients with ALL includes events of “febrile neutropenia” (11
(14%)) plus the concurrent events of “fever” and “neutropenia” (16
(21%)). In the event of febrile neutropenia, evaluate for infection
and manage with broad spectrum antibiotics, fluids, and other
supportive care as medically indicated.
In immunosuppressed patients, life-threatening and fatal
opportunistic infections have been reported. The possibility of
rare infectious etiologies (e.g., fungal and viral infections such
as HHV-6 and progressive multifocal leukoencephalopathy) should be
considered in patients with neurologic events and appropriate
diagnostic evaluations should be performed.
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 patients with MCL, Grade 3 or higher cytopenias not
resolved by Day 30 following Tecartus infusion occurred in 55%
(45/82) of patients and included thrombocytopenia (38%),
neutropenia (37%), and anemia (17%). In patients with ALL who were
responders to Tecartus treatment, Grade 3 or higher cytopenias not
resolved by Day 30 following Tecartus infusion occurred in 20%
(7/35) of the patients and included neutropenia (12%) and
thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved
by Day 60 following Tecartus infusion occurred in 11% (4/35) of the
patients and included neutropenia (9%) and thrombocytopenia (6%).
Monitor blood counts after Tecartus infusion.
Hypogammaglobulinemia: B cell aplasia and
hypogammaglobulinemia can occur in patients receiving treatment
with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of
patients with MCL and 9% (7/78) of patients with ALL. 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 Tecartus
treatment, and until immune recovery following treatment with
Tecartus.
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 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 non-laboratory adverse
reactions (≥ 20%) were fever, cytokine release syndrome,
hypotension, encephalopathy, tachycardia, nausea, chills, headache,
fatigue, febrile neutropenia, diarrhea, musculoskeletal pain,
hypoxia, rash, edema, tremor, infection with pathogen unspecified,
constipation, decreased appetite, and vomiting. The most common
serious adverse reactions (≥ 2%) were cytokine release syndrome,
febrile neutropenia, hypotension, encephalopathy, fever, infection
with pathogen unspecified, hypoxia, tachycardia, bacterial
infections, respiratory failure, seizure, diarrhea, dyspnea, fungal
infections, viral infections, coagulopathy, delirium, fatigue,
hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema,
and paraparesis.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis and cancer. Gilead operates in more than 35
countries worldwide, with headquarters in Foster City,
California.
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company
based in Santa Monica, California, focused on cell therapy to treat
and potentially cure cancer. As the global cell therapy leader,
Kite has treated more patients with CAR T-cell therapy than any
other company. Kite has the largest in-house cell therapy
manufacturing network in the world, spanning process development,
vector manufacturing, clinical trial supply and commercial product
manufacturing. For more information on Kite, please visit
www.kitepharma.com. Follow Kite on social media on Twitter
(@KitePharma) and LinkedIn.
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 ability of Gilead and Kite to initiate, progress or
complete clinical trials within currently anticipated timelines or
at all, and the possibility of unfavorable results from ongoing or
additional clinical studies, including those involving Tecartus,
Yescarta and magrolimab; the possibility that Gilead and Kite may
make a strategic decision to discontinue development of these
programs and, as a result, these programs may never be successfully
commercialized for the indications currently under evaluation; and
any assumptions underlying any of the foregoing. These and other
risks, uncertainties and factors are described in detail in
Gilead’s Quarterly Report on Form 10-Q for the quarter ended March
31, 2023, as filed with the U.S. Securities and Exchange
Commission. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. The reader is cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties, and is cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements are based on information currently
available to Gilead and Kite, and Gilead and Kite assume no
obligation and disclaim any intent to update any such
forward-looking statements.
Tecartus, Yescarta, Gilead, the Gilead logo,
Kite and the Kite logo are trademarks of Gilead Sciences, Inc., or
its related companies.
For more information about Gilead, please visit
the company’s website 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/20230531006043/en/
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Gilead Media public_affairs@gilead.com
Cressida Robson, Kite Media cressida.robson@gilead.com
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Sep 2023 to Sep 2024