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. 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 www.gilead.com 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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version on businesswire.com: https://www.businesswire.com/news/home/20231128145731/en/
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Media public_affairs@gilead.com
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