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Gilead
’s Leadership in
Metastatic Breast Cancer
Showcased With New Trodelvy Data at San Antonio
Breast Cancer
Symposium 2023
2023-11-30
·
BioSpace
上市批准
临床2期
加速审批
临床3期
临床结果
FOSTER CITY, Calif.--(BUSINESS WIRE)--
Gilead Sciences, Inc.
(Nasdaq: GILD) today announced it will present new data at San Antonio
Breast Cancer
Symposium (SABCS) 2023, supporting the use of
Trodelvy
® (
sacituzumab
govitecan-hziy
) in certain
metastatic triple-negative breast cancer (mTNBC)
and pre-treated
HR+/HER2- metastatic breast cancer (mBC)
patients. Data featured in eight presentations include an analysis of clinical outcomes by age from the Phase 3 TROPiCS-02 study of
Trodelvy
in
HR+/HER2- mBC
, as well as a qualitative analysis of the experiences and perspectives of patients, caregivers and clinicians on clinical meaningfulness in
mBC
treatment decision-making. The study adds to a needed body of research exploring the importance of patient-centered interpretations of clinical meaningfulness (e.g., survival, quality of life). “
Trodelvy
is the first approved
Trop-2-directed ADC
to significantly improve survival in both second-line metastatic TNBC and pre-treated
HR+/HER2- metastatic breast cancer
,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head,
Gilead Oncology
. “The data being presented at SABCS add to the breadth of evidence reinforcing
Trodelvy
's use in these two difficult-to-treat
breast cancers
. Additionally, the real-world data being presented in
metastatic breast cancer
provide insights on quality of life and other measures of health to inform both providers and patients in making treatment decisions.” Table of Accepted Abstracts (all times CDT): Abstract Disposition Abstract Title Poster # PO1-05-09 Wednesday, Dec. 6 12:00 PM ASCENT-07: A Phase 3, Randomized, Open-Label Study of
Sacituzumab
Govitecan
Versus Treatment of Physician’s Choice in Patients with HR+/HER2- Inoperable, Locally Advanced, or Metastatic Breast Cancer Post-Endocrine Therapy Poster # PO1-06-10 Wednesday, Dec. 6 12:00 PM Overall Survival Results From EVER-132-001, a Phase 2B Single-Arm Study of
Sacituzumab
Govitecan
in Chinese Patients with
Metastatic Triple-Negative Breast Cancer
Poster # PO1-04-06 Wednesday, Dec. 6 12:00 PM Exposure-response Analyses of
Sacituzumab
Govitecan Efficacy and Safety in Patients with
Metastatic Breast Cancer
Poster # PO1-06-08 Wednesday, Dec. 6 12:00 PM Treatment Utilization by Race and Insurance Type Among TNBC Patients Poster # PO1-10-06 Wednesday, Dec. 6 12:00 PM Understanding Clinical Meaningfulness in
Metastatic Breast Cancer
Treatment Decision-Making: Experiences and Perspectives of Patients, Caregivers, and Clinicians Poster # PO2-05-03 Wednesday, Dec. 6 5:00 PM Costs Associated with Adverse Events in Patients Receiving Treatment for Hormone Receptor Positive/Human
Epidermal Growth Factor
Receptor-2 Negative
Metastatic Breast Cancer
Poster # PO2-05-02 Wednesday, Dec. 6 5:00 PM Real-World Experience of Patients Receiving Treatment for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor-2 Negative
Metastatic Breast Cancer
: A Global Analysis of Symptoms and Side Effects Poster # PO5-21-09 Friday, Dec. 8 12:00 PM Clinical Outcomes by Age Subgroups in the Phase 3 TROPiCS-02 Study of
Sacituzumab
Govitecan
Versus Treatment of Physician’s Choice in
HR+/HER2‒ Metastatic Breast Cancer
Trodelvy
is recommended as a category 1 preferred treatment for second-line mTNBC and a category 1 preferred treatment for metastatic
HR+/HER2- breast cancer
by the National Comprehensive
Cancer
Network® (NCCN®) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines®).1 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 and bladder 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 microenvironment.
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 in the U.S., the European Union, and multiple other global markets to treat certain patients with pre-treated
HR+/HER2- metastatic breast cancer
. In the U.S.,
Trodelvy
also has accelerated approval for treatment of certain patients with second-line
metastatic urothelial cancer (UC)
; see below for the full U.S. indication for
Trodelvy
.
Trodelvy
is also being developed 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)
,
metastatic small cell lung cancer (SCLC)
,
head and neck cancer
, and
endometrial cancer
. 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
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
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. 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
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 Trodelvy; uncertainties relating to regulatory applications for Trodelvy and related filing and approval timelines, including with respect pending or potential applications for the treatment of metastatic TNBC, HR+/HER2- metastatic breast cancer, metastatic UC, metastatic NSCLC, metastatic SCLC, head and neck cancer, and endometrial cancer, in the currently anticipated timelines or at all;
Gilead
’s ability to receive regulatory approvals for such indications in a timely manner or at all, and the risk that any such approvals may be subject to significant limitations on use; the possibility that
Gilead
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 September 30, 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
Gilead
assumes no obligation and disclaim any intent to update any such forward-looking statements. Trodelvy,
Gilead
and the
Gilead
logo are trademarks of
Gilead Sciences, Inc.
, or its related companies. For more information about
Gilead
, please visit the company’s website at or call
Gilead
Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. 1 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for
Breast Cancer
Version 4.2023. © National Comprehensive
Cancer
Network, Inc. 2023. All rights reserved. Accessed November 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
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适应症
转移性乳腺癌
乳腺癌
三阴性乳腺癌
[+40]
靶点
EGF
Trop-2
PD-1
[+4]
药物
戈沙妥组单抗
Sacituzumab
注射用重组人源化抗Trop2单克隆抗体-美登素偶联物
[+7]
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