- First HER2 directed medicine approved for patients with gastric
cancer in a decade
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and
AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been
approved in the U.S. for the treatment of adult patients with
locally advanced or metastatic HER2 positive gastric or
gastroesophageal junction (GEJ) adenocarcinoma who have received a
prior trastuzumab-based regimen.
In the U.S., gastric cancer is more frequently diagnosed in the
advanced stage, with only approximately 5% of patients surviving
five years.1,2 Approximately one in five gastric cancers are HER2
positive.3
“Patients with metastatic HER2 positive gastric cancer with
progression following first-line treatment have historically faced
poor outcomes, including low response to treatment and rapid
disease progression,” said Ronan Kelly, MD, MBA, Director of the
Charles A. Sammons Cancer Center and the W.W. Caruth, Jr. Chair of
Immunology at Baylor University Medical Center, Dallas, Texas.
“This approval represents the first time a HER2 directed medicine
has demonstrated a significant improvement in survival compared to
chemotherapy for patients following initial treatment in the
metastatic setting and it has the potential to become the new
standard of care for this patient population.”
Regular approval by the U.S. Food and Drug Administration (FDA)
was based on the positive results from the randomized pivotal
DESTINY-Gastric01 phase 2 trial, in which ENHERTU demonstrated a
statistically significant and clinically meaningful improvement in
overall survival (OS) and objective response rate (ORR) versus
chemotherapy (irinotecan or paclitaxel) in patients with advanced
gastric or GEJ adenocarcinoma who had progressed on at least two
prior regimens including trastuzumab, a fluoropyrimidine and a
platinum-containing chemotherapy. ENHERTU is approved with Boxed
WARNINGS for interstitial lung disease (ILD)/pneumonitis and
embryo-fetal toxicity.
In the DESTINY-Gastric01 trial, patients (n=126) in the ENHERTU
treatment arm had a 41% reduction in the risk of death versus
patients (n=62) treated with chemotherapy (based on a hazard ratio
[HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; p=0.0097) at
a pre-specified interim analysis with a median OS of 12.5 months
[95% CI 9.6-14.3] versus 8.4 months [95% CI 6.9-10.7] with
chemotherapy.
Confirmed ORR, assessed by independent central review, was a
major efficacy outcome. Results showed a confirmed ORR of 40.5%
[95% CI 31.8-49.6] with ENHERTU compared to 11.3% [95% CI 4.7-21.9]
with chemotherapy. Patients treated with ENHERTU had a 7.9%
complete response rate (n=10) and a 32.5% partial response rate
(n=41) compared to a complete response rate of 0% (n=0) and a
partial response rate of 11.3% (n=7) for patients treated with
chemotherapy. Additionally, ENHERTU showed a median duration of
response (DoR) of 11.3 months [95% CI 5.6-NR] versus 3.9 months
[95% CI 3.0-4.9] with chemotherapy.
ENHERTU also demonstrated a median progression-free survival
(PFS) of 5.6 months [95% CI 4.3-6.9] compared to 3.5 months [95% CI
2.0-4.3] (HR=0.47; 95% CI 0.31-0.71) with chemotherapy.
Results from the DESTINY-Gastric01 trial were presented at the
2020 American Society of Clinical Oncology (ASCO) meeting and
published in The New England Journal of Medicine.4
ENHERTU is approved with Boxed WARNINGS for interstitial lung
disease (ILD)/pneumonitis and embryo-fetal toxicity. The safety of
ENHERTU was evaluated in 187 patients with locally advanced or
metastatic HER2 positive gastric or GEJ adenocarcinoma in
DESTINY-Gastric01. The most common adverse reactions (≥20%),
including laboratory abnormalities, were hemoglobin decreased,
white blood cell count decreased, neutrophil count decreased,
lymphocyte count decreased, platelet count decreased, nausea,
decreased appetite, anemia, aspartate aminotransferase increased,
fatigue, blood alkaline phosphatase increased, alanine
aminotransferase increased, diarrhea, hypokalemia, vomiting,
constipation, blood bilirubin increased, pyrexia, and alopecia. In
DESTINY-Gastric01, of the 125 patients with locally advanced or
metastatic HER2 positive gastric or GEJ adenocarcinoma treated with
ENHERTU 6.4 mg/kg, interstitial lung disease occurred in 10% of
patients. Median time to first onset of ILD was 2.8 months (range:
1.2 to 21.0).
“ENHERTU is the first antibody drug conjugate to receive
approval in the U.S. for the treatment of patients with metastatic
gastric cancer, and represents a major advance in managing this
difficult-to-treat disease,” said Antoine Yver, MD, MSc, Executive
Vice President and Global Head, Oncology Research and Development,
Daiichi Sankyo. “This second indication in the U.S. represents an
important step forward in our ambitious plan to accelerate the
development of ENHERTU across a broad range of HER2 targetable
cancers.”
“Today’s approval of ENHERTU represents the first HER2 directed
medicine approved in a decade for patients with HER2 positive
metastatic gastric cancer,” said Dave Fredrickson, Executive Vice
President, Oncology Business Unit, AstraZeneca. “The results from
the DESTINY-Gastric01 trial highlight the potential to change
clinical practice, showing a forty-one percent improvement in
survival and a response rate more than three times higher with
ENHERTU compared to chemotherapy. We are thrilled to bring this
important medicine to more patients and physicians in the U.S.”
This is the second regulatory approval for ENHERTU in the U.S.
ENHERTU is also approved in the U.S. under accelerated approval,
and in Japan, under the conditional early approval system, for the
treatment of adult patients with unresectable or metastatic HER2
positive breast cancer who have received two or more prior
anti-HER2-based regimens in the metastatic setting based on the
DESTINY-Breast01 trial. ENHERTU is also approved in Japan for HER2
positive unresectable advanced or recurrent gastric cancer that has
progressed after chemotherapy based on the DESTINY-Gastric01
trial.
ENHERTU previously received Priority Review and Breakthrough
Therapy Designation (BTD) in the U.S. for the treatment of patients
with previously treated HER2 positive metastatic gastric cancer, as
well as Orphan Drug Designation (ODD) for patients with gastric
cancer, including gastroesophageal junction cancer. Two additional
phase 2 trials, DESTINY-Gastric02 and DESTINY-Gastric03, are
underway, further evaluating the use of ENHERTU in patients with
HER2 positive metastatic gastric cancer.
Daiichi Sankyo and AstraZeneca are committed to ensuring that
patients in the U.S. who are prescribed ENHERTU can access the
medication and receive necessary financial support. Provider and
patient support, reimbursement and distribution for ENHERTU in the
U.S. will be accessible by visiting www.ENHERTU4U.com or calling
1-833-ENHERTU (1-833-364-3788).
Please visit www.ENHERTU.com for full Prescribing Information,
including Boxed WARNINGS, and Medication Guide.
About Gastric Cancer Gastric (stomach) cancer is the
fifth most common cancer worldwide and the third leading cause of
cancer mortality with a five-year survival rate of 5% for
metastatic disease; there were approximately one million new cases
reported in 2020 and more than 768,000 deaths.2,5 In the U.S., it
is estimated that 27,600 new cases of gastric cancer were diagnosed
in 2020 and more than 11,000 people died from the disease.6
Approximately one in five gastric cancers are HER2 positive.3
HER2 is a tyrosine kinase receptor growth-promoting protein
expressed on the surface of many types of tumors including breast,
gastric, lung and colorectal cancer. Gastric cancer is usually
diagnosed in the advanced stage, but even when diagnosed in earlier
stages of the disease, the survival rate remains modest.1
Recommended first-line treatment for HER2 positive advanced or
metastatic gastric cancer is combination chemotherapy plus
trastuzumab, an anti-HER2 medicine, which has been shown to improve
survival outcomes when added to chemotherapy. For patients with
metastatic gastric cancer that progresses following initial
treatment with a trastuzumab-based regimen, there were previously
no other approved HER2 targeted medicines prior to the approval of
ENHERTU.3
About DESTINY-Gastric01 DESTINY-Gastric01 is an
open-label, multi-center, randomized, pivotal phase 2 trial
evaluating the safety and efficacy of ENHERTU (6.4 mg/kg) versus
investigator’s choice of chemotherapy in a primary cohort of 188
patients from Japan and South Korea with HER2 positive (defined as
IHC3+ or IHC2+/ISH+), advanced gastric or GEJ adenocarcinoma who
had progressed on two or more prior treatment regimens including
trastuzumab, a fluoropyrimidine and platinum-containing
chemotherapy. Patients were randomized 2:1 to receive ENHERTU or
investigator’s choice of chemotherapy (paclitaxel or irinotecan
monotherapy). Patients were treated with ENHERTU 6.4mg/kg once
every three weeks or chemotherapy.
The main efficacy outcome measures were ORR assessed by
independent central review according to RECIST v1.1 and OS in the
intent-to-treat population. Additional efficacy outcome measures
were PFS and DoR.
About ENHERTU ENHERTU® (trastuzumab deruxtecan;
fam-trastuzumab deruxtecan-nxki in the U.S.) is a HER2 directed
antibody drug conjugate (ADC). Designed using Daiichi Sankyo’s
proprietary DXd ADC technology, ENHERTU is the lead ADC in the
oncology portfolio of Daiichi Sankyo and the most advanced program
in AstraZeneca’s ADC scientific platform.
ADCs are targeted cancer medicines that deliver cytotoxic
chemotherapy (“payload”) to cancer cells via a linker attached to a
monoclonal antibody that binds to a specific target expressed on
cancer cells. ENHERTU is comprised of a humanized anti-HER2 IgG1
monoclonal antibody with the same amino acid sequence as
trastuzumab attached to a topoisomerase I inhibitor payload, an
exatecan derivative, via a tetrapeptide-based cleavable linker.
ENHERTU (5.4 mg/kg) is approved in the U.S. under accelerated
approval, and in Japan, under the conditional early approval
system, for the treatment of adult patients with unresectable or
metastatic HER2 positive breast cancer who have received two or
more prior anti-HER2-based regimens in the metastatic setting based
on the DESTINY-Breast01 trial, and received a CHMP positive opinion
in December 2020 as monotherapy for the treatment of adult patients
with unresectable or metastatic HER2 positive breast cancer who
have received two or more prior anti-HER2 based regimens. ENHERTU
(6.4 mg/kg) is also approved in the U.S. and Japan for the
treatment of previously treated patients with HER2 positive
metastatic gastric cancer based on the DESTINY-Gastric01 trial.
About the ENHERTU Clinical Development Program A
comprehensive development program is underway globally with nine
pivotal trials evaluating the efficacy and safety of ENHERTU
monotherapy across multiple HER2 targetable cancers including
breast, gastric and lung cancers. Trials in combination with other
anticancer treatments, such as immunotherapy, are also
underway.
In May 2020, ENHERTU received BTD in the U.S. for the treatment
of patients with metastatic non-small cell lung cancer whose tumors
have a HER2 mutation and with disease progression on or after
platinum-based therapy.
In March 2020, the European Medicines Agency’s CHMP granted
ENHERTU accelerated assessment for the treatment of adults with
unresectable or metastatic HER2 positive breast cancer who have
received two or more prior anti-HER2 based regimens.
About the Collaboration between Daiichi Sankyo and
AstraZeneca Daiichi Sankyo and AstraZeneca entered into a
global collaboration to jointly develop and commercialize ENHERTU
(a HER2 directed ADC) in March 2019, and datopotamab deruxtecan
(Dato-DXd; DS-1062; a TROP2 directed ADC) in July 2020, except in
Japan where Daiichi Sankyo maintains exclusive rights. Daiichi
Sankyo is responsible for manufacturing and supply of ENHERTU and
datopotamab deruxtecan.
U.S. Important Safety Information for ENHERTU
Indications ENHERTU is a HER2-directed antibody and
topoisomerase inhibitor conjugate indicated for the treatment of
adult patients with:
- Unresectable or metastatic HER2-positive breast cancer who have
received two or more prior anti-HER2-based regimens in the
metastatic setting. 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 a confirmatory
trial.
- Locally advanced or metastatic HER2-positive gastric or
gastroesophageal junction adenocarcinoma who have received a prior
trastuzumab-based regimen.
WARNING: INTERSTITIAL LUNG DISEASE and
EMBRYO-FETAL TOXICITY
- Interstitial lung disease (ILD) and pneumonitis, including
fatal cases, have been reported with ENHERTU. Monitor for and
promptly investigate signs and symptoms including cough, dyspnea,
fever, and other new or worsening respiratory symptoms. Permanently
discontinue ENHERTU in all patients with Grade 2 or higher
ILD/pneumonitis. Advise patients of the risk and to immediately
report symptoms.
- Exposure to ENHERTU during pregnancy can cause embryo-fetal
harm. Advise patients of these risks and the need for effective
contraception.
Contraindications None.
Warnings and Precautions Interstitial Lung Disease /
Pneumonitis Severe, life-threatening, or fatal interstitial
lung disease (ILD), including pneumonitis, can occur in patients
treated with ENHERTU. Advise patients to immediately report cough,
dyspnea, fever, and/or any new or worsening respiratory symptoms.
Monitor patients for signs and symptoms of ILD. Promptly
investigate evidence of ILD. Evaluate patients with suspected ILD
by radiographic imaging. Consider consultation with a
pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1),
interrupt ENHERTU until resolved to Grade 0, then if resolved in
≤28 days from date of onset, maintain dose. If resolved in >28
days from date of onset, reduce dose one level. Consider
corticosteroid treatment as soon as ILD/pneumonitis is suspected
(e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic
ILD/pneumonitis (Grade 2 or greater), permanently discontinue
ENHERTU. Promptly initiate systemic corticosteroid treatment as
soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day
prednisolone or equivalent) and continue for at least 14 days
followed by gradual taper for at least 4 weeks.
Metastatic Breast Cancer In
clinical studies, of the 234 patients with unresectable or
metastatic HER2-positive breast cancer treated with ENHERTU 5.4
mg/kg, ILD occurred in 9% of patients. Fatal outcomes due to ILD
and/or pneumonitis occurred in 2.6% of patients treated with
ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to
8.3).
Locally Advanced or Metastatic Gastric
Cancer In DESTINY-Gastric01, of the 125 patients with
locally advanced or metastatic HER2-positive gastric or GEJ
adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10%
of patients. Median time to first onset was 2.8 months (range: 1.2
to 21.0).
Neutropenia Severe neutropenia, including febrile
neutropenia, can occur in patients treated with ENHERTU. Monitor
complete blood counts prior to initiation of ENHERTU and prior to
each dose, and as clinically indicated. For Grade 3 neutropenia
(Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt
ENHERTU until resolved to Grade 2 or less, then maintain dose. For
Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until
resolved to Grade 2 or less. Reduce dose by one level. For febrile
neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a
sustained temperature of ≥38ºC for more than 1 hour), interrupt
ENHERTU until resolved. Reduce dose by one level.
Metastatic Breast Cancer In
clinical studies, of the 234 patients with unresectable or
metastatic HER2-positive breast cancer who received ENHERTU
5.4mg/kg, a decrease in neutrophil count was reported in 62% of
patients. Sixteen percent had Grade 3 or 4 decrease in neutrophil
count. Median time to first onset of decreased neutrophil count was
23 days (range: 6 to 547). Febrile neutropenia was reported in 1.7%
of patients.
Locally Advanced or Metastatic Gastric
Cancer In DESTINY-Gastric01, of the 125 patients with
locally advanced or metastatic HER2-positive gastric or GEJ
adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in
neutrophil count was reported in 72% of patients. Fifty-one percent
had Grade 3 or 4 decreased neutrophil count. Median time to first
onset of decreased neutrophil count was 16 days (range: 4 to 187).
Febrile neutropenia was reported in 4.8% of patients.
Left Ventricular Dysfunction Patients treated with
ENHERTU may be at increased risk of developing left ventricular
dysfunction. Left ventricular ejection fraction (LVEF) decrease has
been observed with anti-HER2 therapies, including ENHERTU. In the
234 patients with unresectable or metastatic HER2-positive breast
cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF
decrease were reported. In DESTINY-Gastric01, of the 125 patients
with locally advanced or metastatic HER2-positive gastric or GEJ
adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse
events of heart failure were reported; however, on
echocardiography, 8% were found to have asymptomatic Grade 2
decrease in LVEF. Treatment with ENHERTU has not been studied in
patients with a history of clinically significant cardiac disease
or LVEF <50% prior to initiation of treatment.
Assess LVEF prior to initiation of ENHERTU and at regular
intervals during treatment as clinically indicated. When LVEF is
>45% and absolute decrease from baseline is 10-20%, continue
treatment with ENHERTU. When LVEF is 40-45% and absolute decrease
from baseline is <10%, continue treatment with ENHERTU and
repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and
absolute decrease from baseline is 10-20%, interrupt ENHERTU and
repeat LVEF assessment within 3 weeks. If LVEF has not recovered to
within 10% from baseline, permanently discontinue ENHERTU. If LVEF
recovers to within 10% from baseline, resume treatment with ENHERTU
at the same dose. When LVEF is <40% or absolute decrease from
baseline is >20%, interrupt ENHERTU and repeat LVEF assessment
within 3 weeks. If LVEF of <40% or absolute decrease from
baseline of >20% is confirmed, permanently discontinue ENHERTU.
Permanently discontinue ENHERTU in patients with symptomatic
congestive heart failure.
Embryo-Fetal Toxicity ENHERTU can cause fetal harm when
administered to a pregnant woman. Advise patients of the potential
risks to a fetus. Verify the pregnancy status of females of
reproductive potential prior to the initiation of ENHERTU. Advise
females of reproductive potential to use effective contraception
during treatment and for at least 7 months following the last dose
of ENHERTU. Advise male patients with female partners of
reproductive potential to use effective contraception during
treatment with ENHERTU and for at least 4 months after the last
dose of ENHERTU.
Additional Dose Modifications Thrombocytopenia For Grade
3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt
ENHERTU until resolved to Grade 1 or less, then maintain dose. For
Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt
ENHERTU until resolved to Grade 1 or less. Reduce dose by one
level.
Adverse Reactions Metastatic Breast
Cancer The safety of ENHERTU was evaluated in a pooled
analysis of 234 patients with unresectable or metastatic
HER2-positive breast cancer who received at least one dose of
ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101.
ENHERTU was administered by intravenous infusion once every three
weeks. The median duration of treatment was 7 months (range: 0.7 to
31).
Serious adverse reactions occurred in 20% of patients receiving
ENHERTU. Serious adverse reactions in >1% of patients who
received ENHERTU were interstitial lung disease, pneumonia,
vomiting, nausea, cellulitis, hypokalemia, and intestinal
obstruction. Fatalities due to adverse reactions occurred in 4.3%
of patients including interstitial lung disease (2.6%), and the
following events occurred in one patient each (0.4%): acute hepatic
failure/acute kidney injury, general physical health deterioration,
pneumonia, and hemorrhagic shock.
ENHERTU was permanently discontinued in 9% of patients, of which
ILD accounted for 6%. Dose interruptions due to adverse reactions
occurred in 33% of patients treated with ENHERTU. The most frequent
adverse reactions (>2%) associated with dose interruption were
neutropenia, anemia, thrombocytopenia, leukopenia, upper
respiratory tract infection, fatigue, nausea, and ILD. Dose
reductions occurred in 18% of patients treated with ENHERTU. The
most frequent adverse reactions (>2%) associated with dose
reduction were fatigue, nausea, and neutropenia.
The most common (≥20%) adverse reactions, including laboratory
abnormalities, were nausea (79%), white blood cell count decreased
(70%), hemoglobin decreased (70%), neutrophil count decreased
(62%), fatigue (59%), vomiting (47%), alopecia (46%), aspartate
aminotransferase increased (41%), alanine aminotransferase
increased (38%), platelet count decreased (37%), constipation
(35%), decreased appetite (32%), anemia (31%), diarrhea (29%),
hypokalemia (26%), and cough (20%).
Locally Advanced or Metastatic Gastric
Cancer The safety of ENHERTU was evaluated in 187 patients
with locally advanced or metastatic HER2-positive gastric or GEJ
adenocarcinoma in DESTINY-Gastric01. Patients intravenously
received at least one dose of either ENHERTU (N=125) 6.4 mg/kg once
every three weeks or either irinotecan (N=55) 150 mg/m2 biweekly or
paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks. The median duration
of treatment was 4.6 months (range: 0.7 to 22.3) in the ENHERTU
group and 2.8 months (range: 0.5 to 13.1) in the
irinotecan/paclitaxel group.
Serious adverse reactions occurred in 44% of patients receiving
ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients
who received ENHERTU were decreased appetite, ILD, anemia,
dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor
hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of
patients: disseminated intravascular coagulation, large intestine
perforation, and pneumonia occurred in one patient each (0.8%).
ENHERTU was permanently discontinued in 15% of patients, of
which ILD accounted for 6%. Dose interruptions due to adverse
reactions occurred in 62% of patients treated with ENHERTU. The
most frequent adverse reactions (>2%) associated with dose
interruption were neutropenia, anemia, decreased appetite,
leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia,
upper respiratory tract infection, diarrhea, and hypokalemia. Dose
reductions occurred in 32% of patients treated with ENHERTU. The
most frequent adverse reactions (>2%) associated with dose
reduction were neutropenia, decreased appetite, fatigue, nausea,
and febrile neutropenia.
The most common (≥20%) adverse reactions, including laboratory
abnormalities, were hemoglobin decreased (75%), white blood cell
count decreased (74%), neutrophil count decreased (72%), lymphocyte
count decreased (70%), platelet count decreased (68%), nausea
(63%), decreased appetite (60%), anemia (58%), aspartate
aminotransferase increased (58%), fatigue (55%), blood alkaline
phosphatase increased (54%), alanine aminotransferase increased
(47%), diarrhea (32%), hypokalemia (30%), vomiting (26%),
constipation (24%), blood bilirubin increased (24%), pyrexia (24%),
and alopecia (22%).
Use in Specific Populations
- Pregnancy: ENHERTU can cause fetal harm when
administered to a pregnant woman. Advise patients of the potential
risks to a fetus. There are clinical considerations if ENHERTU is
used in pregnant women, or if a patient becomes pregnant within 7
months following the last dose of ENHERTU.
- Lactation: There are no data regarding the presence of
ENHERTU in human milk, the effects on the breastfed child, or the
effects on milk production. Because of the potential for serious
adverse reactions in a breastfed child, advise women not to
breastfeed during treatment with ENHERTU and for 7 months after the
last dose.
- Females and Males of Reproductive Potential:
Pregnancy testing: Verify pregnancy
status of females of reproductive potential prior to initiation of
ENHERTU. Contraception: Females:
ENHERTU can cause fetal harm when administered to a pregnant woman.
Advise females of reproductive potential to use effective
contraception during treatment with ENHERTU and for at least 7
months following the last dose. Males: Advise male patients with
female partners of reproductive potential to use effective
contraception during treatment with ENHERTU and for at least 4
months following the last dose. Infertility: ENHERTU may impair male reproductive
function and fertility.
- Pediatric Use: Safety and effectiveness of ENHERTU have
not been established in pediatric patients.
- Geriatric Use: Of the 234 patients with HER2-positive
breast cancer treated with ENHERTU 5.4 mg/kg, 26% were ≥65 years
and 5% were ≥75 years. No overall differences in efficacy were
observed between patients ≥65 years of age compared to younger
patients. There was a higher incidence of Grade 3-4 adverse
reactions observed in patients aged ≥65 years (53%) as compared to
younger patients (42%). Of the 125 patients with locally advanced
or metastatic HER2-positive gastric or GEJ adenocarcinoma treated
with ENHERTU 6.4 mg/kg in DESTINY-Gastric01, 56% were ≥65 years and
14% were ≥75 years. No overall differences in efficacy or safety
were observed between patients ≥65 years of age compared to younger
patients.
- Hepatic Impairment: In patients with moderate hepatic
impairment, due to potentially increased exposure, closely monitor
for increased toxicities related to the topoisomerase
inhibitor.
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi
Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or
fda.gov/medwatch.
Please see accompanying full Prescribing Information,
including Boxed WARNINGS, and Medication Guide.
About Daiichi Sankyo Daiichi Sankyo Group is dedicated to
the creation and supply of innovative pharmaceutical therapies to
improve standards of care and address diversified, unmet medical
needs of people globally by leveraging our world-class science and
technology. With more than 100 years of scientific expertise and a
presence in more than 20 countries, Daiichi Sankyo and its 15,000
employees around the world draw upon a rich legacy of innovation
and a robust pipeline of promising new medicines to help people. In
addition to a strong portfolio of medicines for cardiovascular
diseases, under the Group’s 2025 Vision to become a “Global Pharma
Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo
is primarily focused on providing novel therapies in oncology, as
well as other research areas centered around rare diseases and
immune disorders. For more information, please visit:
www.daiichisankyo.com.
ENHERTU® is a registered trademark of Daiichi Sankyo Company,
Ltd.
_____________________ References: 1 Curea F.G, et al. Cancer
Biotherapy & Radiopharmaceuticals. 2017;32 (10). 2 American
Cancer Society. Stomach Cancer: Stomach Cancer Survival Rates.
October 2020. 3 American Cancer Society. Targeted Therapies for
Stomach Cancer. October 2020. 4 Shitara, K et al. N Engl J Med.
2020;382(25):2419-2430. 5 Global Cancer Observatory. World.
Accessed January 2021. 6 National Cancer Institute. Cancer Stat
Facts: Stomach Cancer. Accessed January 2021.
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Media:
Global/US: Victoria Amari Daiichi Sankyo, Inc.
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11780861 (mobile)
Japan: Masashi Kawase Daiichi Sankyo Co., Ltd.
kawase.masashi.a2@daiichisankyo.co.jp +81 3 6225 1126 (office)
Investor Relations:
DaiichiSankyoIR@daiichisankyo.co.jp