– Non-Small Cell Lung Cancer Development
Program Data to be Presented, Including the Phase 3 EVOKE-01 Study
–
– Updated Results from Phase 2 EDGE-Gastric
Study of Fc-Silent Anti-TIGIT Domvanalimab Plus
Anti-PD-1 Zimberelimab, to be Presented –
– Pilot Study Results of Yescarta® in
Relapsed/Refractory Primary and Secondary Central Nervous System
Lymphomas, an Area of Unmet Clinical Need, to be Presented Orally
–
Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company,
will present 18 abstracts during the 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting. These data showcase the
ongoing commitment to developing differentiated approaches to
transform how cancer is treated and span solid tumors and blood
cancers, including lung, breast, gastrointestinal, colorectal,
leukemia and lymphoma.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240506028033/en/
New Data Provide Detail on Trodelvy in Non-Small Cell Lung
Cancer (NSCLC)
Gilead is presenting primary results from the global Phase 3
EVOKE-01 study of Trodelvy® (sacituzumab govitecan-hziy) versus
docetaxel in patients with advanced or metastatic NSCLC that has
progressed on or after platinum-based chemotherapy and checkpoint
inhibitor therapy. In addition, Gilead will present longer-term
results from Cohort A of the Phase 2 EVOKE-02 study of Trodelvy in
combination with KEYTRUDA® (pembrolizumab) in first-line advanced
or metastatic squamous/non-squamous PD-L1-high NSCLC.
Gilead Highlights Progress in Gastrointestinal
Pipeline
An updated analysis from the Phase 2 EDGE-Gastric study will be
featured as a rapid oral presentation in partnership with Arcus
Biosciences. These longer-term efficacy and safety results for
domvanalimab, an Fc-silent anti-TIGIT antibody, plus the anti-PD-1
antibody zimberelimab and chemotherapy, as a potential first-line
treatment for upper gastrointestinal cancers follow the encouraging
ORR and six-month PFS rate results from the preliminary analysis
presented during the November 2023 virtual ASCO Plenary Series.
Additionally, an oral presentation with our partner Arcus
Biosciences will feature data from Cohort B of ARC-9, a Phase 1b/2
study evaluating the safety and efficacy of etrumadenant, a dual
A2a/b adenosine receptor antagonist, plus zimberelimab, and
FOLFOX/bevacizumab in third-line metastatic colorectal cancer
(mCRC).
Kite Showcases New Data on CAR T-cell Therapies
A pilot collaborative study evaluating Yescarta® (axicabtagene
ciloleucel) for the treatment of patients with relapsed/refractory
(R/R) primary and secondary central nervous system lymphoma (PCNSL
and SCNSL) will be presented orally. These updated data will
highlight the efficacy and safety of Yescarta in this patient
population with important unmet need.
Additionally, updated overall survival outcomes for Tecartus®
(brexucabtagene autoleucel) from the pivotal Phase 1/2 ZUMA-3
trial, now with more than four years of follow-up, will be
presented. The ZUMA-3 trial is the longest follow-up in an
adult-only study of a CAR T-cell therapy for R/R B-cell
lymphoblastic leukemia (B-ALL). These data continue to support the
long-term survival and durability of Tecartus.
Summary of Presentations
Accepted abstracts at the 2024 ASCO Annual Meeting include:
Tumor Types
Abstract Title
B-cell Acute Lymphoblastic
Leukemia
Abstract #6531
June 3, 2024
9:00 AM – 12:00 PM CDT
(Poster)
Long-term Survival Outcomes of Patients
(pts) with Relapsed or Refractory B-cell Acute Lymphoblastic
Leukemia (R/R B-ALL) Treated with Brexucabtagene Autoleucel
(brexu-cel) in ZUMA-3
Biliary Tract Cancer
Abstract #TPS4195
June 1, 2024
1:30 – 4:30 PM CDT (TiP)
Phase 2 Study of Gemcitabine, Cisplatin,
Quemliclustat (AB680) and Zimberelimab (AB122) During First-Line
Treatment of Advanced Biliary Tract Cancers (BTC) – Big Ten Cancer
Research Consortium Study BTCRC-GI22-564
Breast Cancer
Abstract #LBA1004
June 1, 2024
3:00-6:00 PM CDT (Oral Presentation)
SACI-IO HR+: A Randomized Phase II Trial
of Sacituzumab Govitecan with or without Pembrolizumab in Patients
with Metastatic Hormone Receptor-positive/HER2-negative Breast
Cancer*
Abstract #1101
June 2, 2024
9:00 AM – 12:00 PM CDT (Poster)
Prevention of Sacituzumab Govitecan
(SG)-related Neutropenia and Diarrhea in Patients (pts) with
Triple-negative or HR+/HER2- Advanced Breast Cancer (ABC) (PRIMED):
a Phase 2 Trial**
Abstract #1075
June 2, 2024
9:00 AM – 12:00 PM CDT (Poster)
Genomic Alterations in DNA Damage Response
(DDR) Genes in HR+/HER2- Metastatic Breast Cancer (mBC) and Impact
on Clinical Efficacy with Sacituzumab Govitecan (SG): Biomarker
Results from TROPiCS-02 Study
Abstract #1102
June 2, 2024
9:00 AM – 12 PM CDT
(Poster)
Sequential Combination of Sacituzumab
Govitecan and PARP Inhibitor Talazoparib in Metastatic Triple
Negative Breast Cancer (mTNBC): Results from the Phase II Study
Abstract #TPS1140
June 2, 2024
9:00 AM – 12 PM CDT
(TiP)
Trial in Progress: Phase I/II Study of
Stereotactic Radiation and Sacituzumab Govitecan with Zimberelimab
in the Management of Metastatic Triple Negative Breast Cancer with
Brain Metastases
Central Nervous System Lymphoma
Abstract #2006
June 3, 2024
8:00 – 11:00 AM CDT
(Oral Presentation)
A Pilot Study of Axicabtagene Ciloleucel
(axi-cel) for the Treatment of Relapsed/Refractory Primary and
Secondary Central Nervous System Lymphoma (PCNSL and SCNSL)*
Colorectal Cancer
Abstract #3508
June 2, 2024
8:00 – 11:00 AM CDT (Oral
Presentation)
Randomized Phase 1b/2 Study to Evaluate
Etrumadenant Based Treatment Combinations in Previously Treated
Metastatic Colorectal Cancer (mCRC)
Gastroesophageal Cancers
Abstract #433248
June 1, 2024
12:30 – 1:30 PM CDT (Oral
Presentation)
EDGE-Gastric Arm A1: Phase 2 Study of
Domvanalimab, Zimberelimab, and FOLFOX in First-Line Advanced
Gastroesophageal Cancer
Lung Cancer
Abstract #LBA8500
May 31, 2024
2:45 – 5:45 PM CDT (Oral Presentation)
Sacituzumab Govitecan (SG) vs Docetaxel
(doc) in Patients (pts) with Metastatic Non-small Cell Lung Cancer
(mNSCLC) Previously Treated with Platinum (PT)-based Chemotherapy
(chemo) and PD(L)-1Inhibitors (IO): Primary Results from the Phase
3 EVOKE-01 Study
Abstract #8592
June 3, 2024
1:30 – 4:30 PM CDT
(Poster)
Sacituzumab Govitecan (SG) + Pembrolizumab
(pembro) in First-line (1L) Metastatic Non-small Cell Lung Cancer
(mNSCLC): Results from Longer Follow-up of Cohort A of EVOKE-02
Abstract #TPS8121
June 3, 2024
1:30 – 4:30 PM CDT (TiP)
VELOCITY-Lung Substudy-03: a Phase 2 Study
Evaluating Safety and Efficacy of Domvanalimab (Dom) + Zimberelimab
(Zim) or Zim Alone in Combination with Chemotherapy (Chemo) in the
Neoadjuvant Phase and Dom+Zim or Zim Alone in the Adjuvant Phase in
Patients with Resectable Stage II-III Non-small Cell Lung Cancer
(NSCLC)
Rare Genitourinary Tumors
Abstract #TPS4627
June 2, 2024
9:00 AM – 12 PM CDT
(TiP)
SMART: A Phase II Study of Sacituzumab
Govitecan (SG) with or without Atezolizumab Immunotherapy in Rare
Genitourinary (GU) Tumors such as Small Cell, Adenocarcinoma, and
Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary
Carcinoma (RMC) and Penile Cancer*
Solid Tumors
Abstract #3029
June 1, 2024
9:00 AM – 12:00 PM CDT (Poster)
Pooled Safety Analysis of Sacituzumab
Govitecan (SG) in Multiple Solid Tumor Types
Thyroid Cancer
Abstract #TPS6130
June 2, 2024
9:00 AM – 12:00 PM CDT
(TiP)
Sacituzumab Govitecan in Patients with
Advanced or Metastatic Radioactive-iodine Refractory Thyroid
Carcinoma: The Phase 2 SETHY, GETNE-T2318 Trial
Urothelial Cancer
Abstract #e16500
May 23, 2024
4:00 PM CDT
(Online Publication Only)
Treatment Patterns of Metastatic
Urothelial Cancer in the United States
Abstract #TPS4618
June 2, 2024
9:00 AM – 12:00 PM CDT (TiP)
Sacituzumab Govitecan (SG) plus Enfortumab
Vedotin (EV) for Metastatic Urothelial Carcinoma (mUC) Treatment
Experienced (DAD) and with Pembrolizumab (P) in Treatment Naïve UC
(DAD-IO)**
*Collaborative study with Dana-Farber Cancer Institute
**Collaborative study
Domvanalimab, zimberelimab and etrumadenant are investigational
molecules. Neither Gilead nor Arcus has received approval from any
regulatory authority for any use of these molecules, and their
safety and efficacy for the treatment of gastrointestinal and lung
cancers have not been established.
Trodelvy has not been approved by any regulatory agency for the
treatment of metastatic NSCLC. Its safety and efficacy have not
been established for this indication. Trodelvy has a Boxed Warning
for severe or life-threatening neutropenia and severe diarrhea;
please see below for the approved U.S. Indication and additional
Important Safety Information.
About Trodelvy
Trodelvy® (sacituzumab govitecan-hziy) is a first-in-class
Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface
antigen highly expressed in multiple tumor types, including in more
than 90% of breast, bladder and lung cancers. Trodelvy is
intentionally designed with a proprietary hydrolyzable linker
attached to SN-38, a topoisomerase I inhibitor payload. This unique
combination delivers potent activity to both Trop-2 expressing
cells and the tumor microenvironment through a bystander
effect.
Trodelvy is approved in almost 50 countries, with multiple
additional regulatory reviews underway worldwide, for the treatment
of adult patients with unresectable locally advanced or metastatic
triple-negative breast cancer (TNBC) who have received two or more
prior systemic therapies, at least one of them for metastatic
disease.
Trodelvy is also approved to treat certain patients with
pre-treated HR+/HER2- metastatic breast cancer in Australia,
Brazil, Canada, the European Union, Israel, United Arab Emirates
and the United States. In the U.S., Trodelvy has an accelerated
approval for treatment of certain patients with second-line
metastatic urothelial cancer; see below for full indication
statements.
Trodelvy is being explored for potential investigational use in
other TNBC, HR+/HER2- and metastatic UC populations, as well as a
range of tumor types where Trop-2 is highly expressed, including
metastatic non-small cell lung cancer (NSCLC), head and neck
cancer, gynecological cancer, and gastrointestinal cancers.
U.S. Indications for
Trodelvy
In the United States, Trodelvy is indicated for the treatment of
adult patients with:
- Unresectable locally advanced or metastatic triple-negative
breast cancer (mTNBC) who have received two or more prior systemic
therapies, at least one of them for metastatic disease.
- Unresectable locally advanced or metastatic hormone receptor
(HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who
have received endocrine-based therapy and at least two additional
systemic therapies in the metastatic setting.
- Locally advanced or metastatic urothelial cancer (mUC) who have
previously received a platinum-containing chemotherapy and either
programmed death receptor-1 (PD-1) or programmed death-ligand 1
(PD-L1) inhibitor. This indication is approved under accelerated
approval based on tumor response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
U.S. Important Safety Information for
Trodelvy
BOXED WARNING: NEUTROPENIA AND DIARRHEA
- Severe or life-threatening neutropenia may occur. Withhold
Trodelvy for absolute neutrophil count below 1500/mm3 or
neutropenic fever. Monitor blood cell counts periodically during
treatment. Consider G-CSF for secondary prophylaxis. Initiate
anti-infective treatment in patients with febrile neutropenia
without delay.
- Severe diarrhea may occur. Monitor patients with diarrhea and
give fluid and electrolytes as needed. At the onset of diarrhea,
evaluate for infectious causes and, if negative, promptly initiate
loperamide. If severe diarrhea occurs, withhold Trodelvy until
resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS
- Severe hypersensitivity reaction to Trodelvy.
WARNINGS AND PRECAUTIONS
Neutropenia: Severe, life-threatening, or fatal neutropenia can
occur and may require dose modification. Neutropenia occurred in
64% of patients treated with Trodelvy. Grade 3-4 neutropenia
occurred in 49% of patients. Febrile neutropenia occurred in 6%.
Neutropenic colitis occurred in 1.4%. Withhold Trodelvy for
absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or
neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold
Trodelvy for neutropenic fever. Administer G-CSF as clinically
indicated or indicated in Table 1 of USPI.
Diarrhea: Diarrhea occurred in 64% of all patients treated with
Trodelvy. Grade 3-4 diarrhea occurred in 11% of patients. One
patient had intestinal perforation following diarrhea. Diarrhea
that led to dehydration and subsequent acute kidney injury occurred
in 0.7% of all patients. Withhold Trodelvy for Grade 3-4 diarrhea
and resume when resolved to ≤Grade 1. At onset, evaluate for
infectious causes and if negative, promptly initiate loperamide, 4
mg initially followed by 2 mg with every episode of diarrhea for a
maximum of 16 mg daily. Discontinue loperamide 12 hours after
diarrhea resolves. Additional supportive measures (e.g., fluid and
electrolyte substitution) may also be employed as clinically
indicated. Patients who exhibit an excessive cholinergic response
to treatment can receive appropriate premedication (e.g., atropine)
for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: Serious
hypersensitivity reactions including life-threatening anaphylactic
reactions have occurred with Trodelvy. Severe signs and symptoms
included cardiac arrest, hypotension, wheezing, angioedema,
swelling, pneumonitis, and skin reactions. Hypersensitivity
reactions within 24 hours of dosing occurred in 35% of patients.
Grade 3-4 hypersensitivity occurred in 2% of patients. The
incidence of hypersensitivity reactions leading to permanent
discontinuation of Trodelvy was 0.2%. The incidence of anaphylactic
reactions was 0.2%. Pre-infusion medication is recommended. Have
medications and emergency equipment to treat such reactions
available for immediate use. Observe patients closely for
hypersensitivity and infusion-related reactions during each
infusion and for at least 30 minutes after completion of each
infusion. Permanently discontinue Trodelvy for Grade 4
infusion-related reactions.
Nausea and Vomiting: Nausea occurred in 64% of all patients
treated with Trodelvy and Grade 3-4 nausea occurred in 3% of these
patients. Vomiting occurred in 35% of patients and Grade 3-4
vomiting occurred in 2% of these patients. Premedicate with a two
or three drug combination regimen (e.g., dexamethasone with either
a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well
as other drugs as indicated) for prevention of chemotherapy-induced
nausea and vomiting (CINV). Withhold Trodelvy doses for Grade 3
nausea or Grade 3-4 vomiting and resume with additional supportive
measures when resolved to Grade ≤1. Additional antiemetics and
other supportive measures may also be employed as clinically
indicated. All patients should be given take-home medications with
clear instructions for prevention and treatment of nausea and
vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced
UGT1A1 Activity: Patients homozygous for the uridine
diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at
increased risk for neutropenia, febrile neutropenia, and anemia and
may be at increased risk for other adverse reactions with Trodelvy.
The incidence of Grade 3-4 neutropenia was 58% in patients
homozygous for the UGT1A1*28, 49% in patients heterozygous for the
UGT1A1*28 allele, and 43% in patients homozygous for the wild-type
allele. The incidence of Grade 3-4 anemia was 21% in patients
homozygous for the UGT1A1*28 allele, 10% in patients heterozygous
for the UGT1A1*28 allele, and 9% in patients homozygous for the
wild-type allele. Closely monitor patients with known reduced
UGT1A1 activity for adverse reactions. Withhold or permanently
discontinue Trodelvy based on clinical assessment of the onset,
duration and severity of the observed adverse reactions in patients
with evidence of acute early-onset or unusually severe adverse
reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action,
Trodelvy can cause teratogenicity and/or embryo-fetal lethality
when administered to a pregnant woman. Trodelvy contains a
genotoxic component, SN-38, and targets rapidly dividing cells.
Advise pregnant women and females of reproductive potential of the
potential risk to a fetus. Advise females of reproductive potential
to use effective contraception during treatment with Trodelvy and
for 6 months after the last dose. Advise male patients with female
partners of reproductive potential to use effective contraception
during treatment with Trodelvy and for 3 months after the last
dose.
ADVERSE REACTIONS
In the pooled safety population, the most common (≥ 25%) adverse
reactions including laboratory abnormalities were decreased
leukocyte count (84%), decreased neutrophil count (75%), decreased
hemoglobin (69%), diarrhea (64%), nausea (64%), decreased
lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation
(37%), increased glucose (37%), decreased albumin (35%), vomiting
(35%), decreased appetite (30%), decreased creatinine clearance
(28%), increased alkaline phosphatase (28%), decreased magnesium
(27%), decreased potassium (26%), and decreased sodium (26%).
In the ASCENT study (locally advanced or metastatic
triple-negative breast cancer), the most common adverse reactions
(incidence ≥25%) were fatigue, diarrhea, nausea, alopecia,
constipation, vomiting, abdominal pain, and decreased appetite. The
most frequent serious adverse reactions (SAR) (>1%) were
neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were
reported in 27% of patients, and 5% discontinued therapy due to
adverse reactions. The most common Grade 3-4 lab abnormalities
(incidence ≥25%) in the ASCENT study were reduced neutrophils,
leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic
HR-positive, HER2-negative breast cancer), the most common adverse
reactions (incidence ≥25%) were diarrhea, fatigue, nausea,
alopecia, and constipation. The most frequent serious adverse
reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia
(4%), neutropenia (3%), abdominal pain, colitis, neutropenic
colitis, pneumonia, and vomiting (each 2%). SAR were reported in
28% of patients, and 6% discontinued therapy due to adverse
reactions. The most common Grade 3-4 lab abnormalities (incidence
≥25%) in the TROPiCS-02 study were reduced neutrophils and
leukocytes.
In the TROPHY study (locally advanced or metastatic urothelial
cancer), the most common adverse reactions (incidence ≥25%) were
diarrhea, fatigue, nausea, any infection, alopecia, decreased
appetite, constipation, vomiting, rash, and abdominal pain. The
most frequent serious adverse reactions (SAR) (≥5%) were infection
(18%), neutropenia (12%, including febrile neutropenia in 10%),
acute kidney injury (6%), urinary tract infection (6%), and sepsis
or bacteremia (5%). SAR were reported in 44% of patients, and 10%
discontinued due to adverse reactions. The most common Grade 3-4
lab abnormalities (incidence ≥25%) in the TROPHY study were reduced
neutrophils, leukocytes, and lymphocytes.
DRUG INTERACTIONS
UGT1A1 Inhibitors: Concomitant administration of Trodelvy with
inhibitors of UGT1A1 may increase the incidence of adverse
reactions due to potential increase in systemic exposure to SN-38.
Avoid administering UGT1A1 inhibitors with Trodelvy.
UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients
concomitantly receiving UGT1A1 enzyme inducers. Avoid administering
UGT1A1 inducers with Trodelvy.
Please see full Prescribing Information, including BOXED
WARNING.
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, NEUROLOGIC TOXICITIES,
and SECONDARY HEMATOLOGICAL MALIGNANCIES
- 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.
- T-cell malignancies have occurred following treatment of
hematologic malignancies with BCMA- and CD19-directed genetically
modified autologous T-cell immunotherapies.
- Tecartus is available only through a restricted program under a
Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta
and Tecartus REMS Program.
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 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: Patients treated with TECARTUS may
develop secondary malignancies. T-cell malignancies have occurred
following treatment of hematologic malignancies with BCMA- and
CD19-directed genetically modified autologous T-cell
immunotherapies. Mature T-cell malignancies, including CAR-positive
tumors, may present as soon as weeks following infusions, and may
include fatal outcomes.
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 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.
Please see full Prescribing Information, including BOXED WARNING
and Medication Guide.
About Yescarta
Please see full US 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 the response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the
confirmatory trial(s).
U.S. IMPORTANT SAFETY INFORMATION
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC
TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES
- 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.
- T-cell malignancies have occurred following treatment of
hematologic malignancies with BCMA-and CD19-directed genetically
modified autologous T cell immunotherapies, including
YESCARTA.
- 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
following treatment with YESCARTA. CRS occurred in 90% (379/422) of
patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 CRS
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 CRS 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 the 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 a higher grade of neurologic toxicities or prolongation
of neurologic toxicities, delay the onset of 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 in 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
Patients treated with YESCARTA may develop secondary
malignancies. T-cell malignancies have occurred following treatment
of hematologic malignancies with BCMA- and CD19-directed
genetically modified autologous T-cell immunotherapies, including
YESCARTA. Mature T-cell malignancies, including CAR-positive
tumors, may present as soon as weeks following infusion, and may
include fatal outcomes.
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 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 an 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 an
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 an
unspecified, tachycardia, febrile neutropenia, musculoskeletal
pain, nausea, tremor, chills, diarrhea, constipation, decreased
appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.
About Domvanalimab
Domvanalimab is the first and most clinically advanced Fc-silent
investigational monoclonal antibody that is specifically designed
with Fc-silent properties to block and bind to the T-cell
immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint
receptor on immune cells that acts as a brake on the anticancer
immune response. By binding to TIGIT with Fc-silent properties,
domvanalimab is believed to work by freeing up immune-activating
pathways and activate immune cells to attack and kill cancer cells
without depleting the peripheral regulatory T cells important in
avoiding immune-related toxicity.
Combined inhibition of both TIGIT and programmed cell death
protein-1 (PD-1) is believed to significantly enhance immune cell
activation, as these checkpoint receptors play distinct,
complementary roles in anti-tumor activity. Domvanalimab is being
evaluated in combination with anti-PD-1 monoclonal antibodies,
including zimberelimab, as well as other investigational cancer
immunotherapies and A2a/A2b adenosine receptor antagonist
etrumadenant, in multiple ongoing and planned early and late-stage
clinical studies in various tumor types.
About Zimberelimab
Zimberelimab is an anti-programmed cell death protein-1 (PD-1)
monoclonal antibody that binds PD-1, with the goal of restoring the
antitumor activity of T cells. Zimberelimab has demonstrated high
affinity, selectivity and potency in various tumor types.
Zimberelimab is being evaluated in the U.S. and globally as a
foundational PD-1 treatment option in multiple ongoing and planned
early and late-stage clinical studies in combination with other
immunotherapies, including investigational Fc-silent anti-TIGIT
monoclonal antibody domvanalimab and A2a/A2b adenosine receptor
antagonist etrumadenant.
Guangzhou Gloria Biosciences Co. Ltd., who holds
commercialization rights for zimberelimab in greater China, has
obtained approval for zimberelimab for the treatment of recurrent
or metastatic cervical cancer and for relapsed or refractory
classical Hodgkin's lymphoma. Zimberelimab is not approved for any
use in the U.S. or other regions outside of China. Gloria conducts
its development and commercialization activities independent of
Arcus and Gilead.
About Etrumadenant
Etrumadenant is an investigational small molecule, selective
dual antagonist of the A2a and A2b receptors designed to prevent
adenosine-mediated immunosuppression. Adenosine elicits its
immunosuppressive effects within the tumor microenvironment by
binding and activating adenosine-specific receptors expressed on
the surface of tumor-infiltrating immune cells, which can help
cancer cells evade host antitumor immunity. Once etrumadenant binds
to the A2a and A2b receptors and blocks the immunosuppressive
effects of adenosine, activation of antitumor immune cells may be
restored, which could result in tumor cell death.
Etrumadenant is being evaluated in combination with other cancer
immunotherapies, including the investigational Fc-silent anti-TIGIT
monoclonal antibody domvanalimab and PD-1 inhibitor zimberelimab,
in certain types of non-small cell lung and colorectal cancers.
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, COVID-19, 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.
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,
Trodelvy, Yescarta, domvanalimab, etrumadenant, and zimberelimab;
uncertainties relating to regulatory applications and related
filing and approval timelines, including pending or potential
applications for indications currently under evaluation; 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 are
described in detail in Gilead’s Annual Report on Form 10-K for the
year ended December 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.
Trodelvy, Yescarta, Tecartus, 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/20240506028033/en/
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Media public_affairs@gilead.com
Anna Padula, Kite Media apadula@kitepharma.com
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