-Data Span Multiple Types of Lung Cancer and
Lines of Therapy-
Gilead Sciences, Inc. (Nasdaq: GILD) will present new data from
the company’s broad lung cancer clinical development program during
the IASLC 2024 World Conference on Lung Cancer hosted by the
International Association for the Study of Lung Cancer, taking
place Sept. 7-10, 2024 in San Diego, Calif. Data to be highlighted
across three oral presentations include: initial results from two
cohorts of the EVOKE-02 study of Trodelvy® (sacituzumab
govitecan-hziy) in previously untreated advanced or metastatic
non-small cell lung cancer (mNSCLC), results from a subgroup
analysis of the EVOKE-01 study of Trodelvy in second-line mNSCLC,
and updated data from the TROPiCS-03 study of Trodelvy in extensive
stage small cell lung cancer (ES-SCLC).
New Findings Further Support the Potential Efficacy of
Trodelvy for mNSCLC in the First-Line Setting
Results to be presented from Cohorts C (non-squamous) and D
(squamous) of the Phase 2 EVOKE-02 study of Trodelvy in previously
untreated mNSCLC in combination with pembrolizumab and carboplatin
demonstrate encouraging efficacy in patients with non-AGA-driven
mNSCLC and across PD-L1 status. These additional findings advance
our scientific understanding of the optimal treatment regimens and
appropriate patient populations with mNSCLC that may potentially
benefit from treatment with Trodelvy in the first-line setting.
“Our data at WCLC will add to the expanding evidence for the
potential of Trodelvy in lung cancer and reinforce our confidence
in our broader lung cancer strategy,” said Merdad Parsey, MD, PhD,
Chief Medical Officer, Gilead Sciences. “The totality of mature
EVOKE-02 data suggest that in the first-line setting, Trodelvy in
combination with pembrolizumab may have a greater potential to
positively impact patients with mNSCLC when given without the
addition of chemotherapy. These findings support the ongoing Phase
3 EVOKE-03 study and underscore our commitment to improving the
standard of care for patients with lung cancer.”
Analysis Shows Overall Survival (OS) Improvement with
Trodelvy in a Subgroup of Second-Line mNSCLC Patients
Additionally, Gilead will present data from the EVOKE-01 study
in the subgroup of patients whose tumors did not respond to their
last anti-PD-(L)1-therapy, building on the primary analysis
presented earlier this year. Results from a pre-specified analysis
showed a numerical OS improvement vs. docetaxel in this patient
population, which was observed across histologies and regardless of
whether patients were stable or progressed after their last
anti-PD-(L)1-containing treatment. This subgroup analysis was not
alpha-controlled for formal statistical testing. These meaningful
data in mNSCLC help advance our understanding of Trodelvy’s
potential for patients with lung cancer.
Longer-Term Follow-up Data from the Phase 2 TROPiCS-03
ES-SCLC Cohort Demonstrate Promising Activity
Gilead will also share updated results from the global Phase 2
TROPiCS-03 ES-SCLC Cohort. These new data, with additional patients
and longer-term follow-up, reinforce promising activity shown with
Trodelvy treatment in patients with both platinum-resistant and
platinum-sensitive disease and support further investigation of
Trodelvy in ES-SCLC, where there is still significant unmet
need.
Summary of Presentations
Accepted abstracts at WCLC 2024 include:
Date/Time
Abstract
September 8, 2:00 PM – 3:15 PM PT
(Oral Presentation)
Abstract #OA04.04: Sacituzumab
Govitecan as Second-Line Treatment in Patients with Extensive Stage
Small Cell Lung Cancer
September 9, 10:45 AM – 12:00 PM
PT (Oral Presentation)
Abstract #OA08.07: Sacituzumab
Govitecan + Pembrolizumab + Carboplatin in 1L Metastatic Non-Small
Cell Lung Cancer: The EVOKE-02 Study
September 9, 10:45 AM – 12:00 PM
PT (Oral Presentation)
Abstract #OA08.06: Sacituzumab
Govitecan vs. Docetaxel in Patients With mNSCLC non-Responsive to
Last anti-PD-(L)1–Containing Regimen: EVOKE-01
Trodelvy has not been approved by any regulatory agency for the
treatment of mNSCLC or ES-SCLC. Its safety and efficacy have not
been established for this use. Trodelvy has a Boxed Warning for
severe or life-threatening neutropenia and severe diarrhea; please
see below for the approved U.S. Indications and 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
mNSCLC, 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 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, cancer, and inflammation. Gilead
operates in more than 35 countries worldwide, with headquarters in
Foster City, Calif.
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
(such as EVOKE-01, EVOKE-02 and TROPiCS-03); uncertainties relating
to regulatory applications and related filing and approval
timelines, including pending or potential applications for Trodelvy
for the treatment of metastatic and other TNBC, HR+/HER2-
metastatic breast cancer, mUC, metastatic NSCLC, head and neck
cancer, gynecological cancer and gastrointestinal cancer; Gilead’s
ability to receive regulatory approvals for programs and/or
indications that are currently under evaluation in a timely manner
or at all, and the risk that any such approvals may be subject to
significant limitations on use and is subject to, withdrawal or
other adverse actions by the applicable regulatory authority; 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 are
described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended June 30, 2024, 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.
U.S. Prescribing Information for Trodelvy,
including BOXED WARNING, is available at www.gilead.com.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X/Twitter
(@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240904599708/en/
Meaghan Smith, Media public_affairs@gilead.com Jacquie Ross,
Investors investor_relations@gilead.com
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Dec 2024 to Jan 2025
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Jan 2024 to Jan 2025
