First HER2-directed medicine approved for
patients with gastric cancer in a decade
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi
Sankyo)’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been
approved in the US 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 US, gastric cancer is more frequently diagnosed in the
advanced stage with only approximately 5% of patients surviving
beyond five years.1,2 Approximately one in five gastric cancers are
HER2 positive.3
The approval by the Food and Drug Administration (FDA) was based
on the positive results from the randomized DESTINY-Gastric01 Phase
II trial conducted in Japan and South Korea. In the trial, 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 cancer or GEJ adenocarcinoma who had
progressed on at least two or more prior regimens including
trastuzumab plus a fluoropyrimidine- and a platinum-containing
chemotherapy combination.4
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, said: “Patients with
metastatic HER2-positive gastric cancer with progression following
1st-line treatment have historically faced poor outcomes, including
low response to treatment and rapid disease progression. This
approval represents the first time a HER2-directed medicine has
demonstrated a significant improvement in survival compared to
chemotherapy following initial treatment in the metastatic setting,
and it has the potential to become the new standard of care for
this patient population.”
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: “Today’s approval of ENHERTU represents the first
HER2-directed medicine in a decade for patients with HER2-positive
metastatic gastric cancer. The results from the DESTINY-Gastric01
trial highlight the potential to change clinical practice, showing
a 41 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 US.”
Antoine Yver, Executive Vice President and Global Head, Oncology
Research and Development, Daiichi Sankyo, said: “ENHERTU is the
first antibody drug conjugate to receive approval in the US for the
treatment of patients with metastatic gastric cancer, and
represents a major advance in managing this difficult-to-treat
disease. This second indication in the US represents an important
step forward in our ambitious plan to accelerate the development of
ENHERTU across a broad range of HER2-targetable cancers.”
In a pre-specified interim analysis from the DESTINY-Gastric01
trial, patients treated with ENHERTU had a 41% reduction in the
risk of death versus patients treated with chemotherapy (based on a
hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88;
p=0.0097) with a median OS of 12.5 months versus 8.4 months.3
Confirmed ORR, assessed by independent central review was a
major efficacy outcome. Results showed a confirmed ORR of 40.5% in
patients treated with ENHERTU (n=126) compared to 11.3% in patients
treated with chemotherapy (n=62). Patients treated with ENHERTU had
a 7.9% complete response rate and a 32.5% partial response rate
compared to a complete response rate of 0% and a partial response
rate of 11.3% for patients treated with chemotherapy.4
ENHERTU demonstrated a median progression-free survival (PFS) of
5.6 months compared to 3.5 months with chemotherapy (HR=0.47; 95%
CI 0.31-0.71). Additionally, ENHERTU showed a median duration of
response (DoR) of 11.3 months versus 3.9 months with
chemotherapy.4
Results from the DESTINY-Gastric01 trial were published in The
New England Journal of Medicine in June 2020.5
ENHERTU is approved with Boxed WARNINGS for interstitial lung
disease (ILD) or pneumonitis and embryo-fetal toxicity. The most
common adverse reactions, including laboratory abnormalities, of
any grade (greater than or equal to 20%) for patients treated with
ENHERTU (n=125) in the DESTINY-Gastric01 trial were anemia,
leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, nausea,
decreased appetite, increased aspartate aminotransferase, fatigue,
increased blood alkaline phosphatase, increased alanine
aminotransferase, diarrhea, hypokalaemia, vomiting, constipation,
increased blood bilirubin, pyrexia and alopecia. Interstitial lung
disease (ILD) or pneumonitis occurred in 10% of patients.4
This is the second indication approved for ENHERTU in the US
following the accelerated approval for 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 was previously granted Priority Review, Breakthrough
Therapy Designation (BTD) in HER2-positive metastatic gastric
cancer and Orphan Drug Designation (ODD) for gastric cancer by the
FDA. Two additional Phase II trials, DESTINY-Gastric02 and
DESTINY-Gastric03, are underway, further evaluating treatment with
ENHERTU in patients with HER2-positive metastatic gastric
cancer.
Please visit www.ENHERTU.com for full Prescribing Information,
including Boxed WARNINGS, and Medication Guide.
Financial considerations
Following US approval, an amount of $115m is due from
AstraZeneca to Daiichi Sankyo as a combined 2nd-line and 3rd-line
milestone payments in HER2-positive gastric cancer. In AstraZeneca,
the milestones paid will be capitalized as an addition to the
upfront payment made in 2019 and subsequent capitalized milestones
and amortised through the profit and loss.
Sales of ENHERTU in the US are recognized by Daiichi Sankyo.
AstraZeneca reports its share of gross profit margin from ENHERTU
sales in the US as collaboration revenue in the Company’s financial
statements. For further details on the financial arrangements,
please consult the collaboration agreement from March 2019.
Important Safety Information
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
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.
Notes
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.6 In the US, it is estimated that 27,600 new cases
of gastric cancer will be diagnosed in 2020 and more than 11,000
people will die from the disease.7
Approximately one in five gastric cancers are HER2 positive.1
HER2 is a tyrosine kinase receptor growth-promoting protein
expressed on the surface of many types of tumors including breast,
gastric, lung and colorectal cancers. Gastric cancer is usually
diagnosed in the advanced stage, but even when diagnosed in earlier
stages of the disease the survival rate remains modest.1,2
Recommended 1st-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.8
DESTINY-Gastric01
DESTINY-Gastric01 is a Phase II, open-label, multi-center,
randomized controlled trial testing the safety and efficacy of
ENHERTU (6.4 mg/kg) versus investigator’s choice of chemotherapy in
a primary cohort of patients from Japan and South Korea with
HER2-positive (defined as IHC3+ or IHC2+/ISH+), locally advanced or
metastatic gastric cancer or GEJ adenocarcinoma who have progressed
on two or more prior regimens including trastuzumab plus a
fluoropyrimidine- and platinum-containing chemotherapy. Patients
(n=188) were randomized 2:1 to receive ENHERTU or physician’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 and OS. Additional efficacy outcome
measures were PFS and DoR.4
ENHERTU
ENHERTU (fam-trastuzumab deruxtecan-nxki) is a HER2-directed
antibody drug conjugate (ADC). It 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 (5.4mg/kg) is approved in the US under accelerated
approval, and in Japan under 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. In addition to the US, ENHERTU (6.4mg/kg)
is also approved in Japan for patients with HER2-positive
unresectable advanced or recurrent gastric cancer that progressed
after chemotherapy based on the DESTINY-Gastric01 trial.
Development program
A comprehensive development program is underway globally, with
nine registrational trials evaluating the efficacy and safety of
ENHERTU monotherapy across multiple HER2 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 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.
Daiichi Sankyo collaboration
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 (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.
AstraZeneca in gastrointestinal (GI) cancers
AstraZeneca has a broad development program for the treatment of
GI cancers across several medicines spanning a variety of tumor
types and stages of disease. In 2020, GI cancers collectively
represented over 5 million new cancer cases leading to more than
3.5 million deaths.6 Within this program, the Company is committed
to improving outcomes in gastric, liver, oesophageal, pancreatic,
and colorectal cancers.
The Company aims to understand the potential of ENHERTU in the
two most common GI cancers, colorectal and gastric cancers.6
Durvalumab is being assessed as both as monotherapy and in
combinations including with tremelimumab across the two main types
of liver cancer, hepatocellular carcinoma and biliary tract cancer,
and in oesophageal and gastric cancers. Olaparib is a PARP
inhibitor with a broad and advanced clinical trial program across
multiple GI tumor types including pancreatic and colorectal
cancers. Olaparib is developed and commercialized in collaboration
with MSD (Merck & Co., Inc. inside the US and Canada).
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential
to transform patients’ lives and the Company’s future. With seven
new medicines launched between 2014 and 2020, and a broad pipeline
of small molecules and biologics in development, the Company is
committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers.
By harnessing the power of six scientific platforms –
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
– and by championing the development of personalized combinations,
AstraZeneca has the vision to redefine cancer treatment and, one
day, eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory & Immunology. AstraZeneca operates
in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information, please visit
www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
References
- Curea F.G, et al. Current Targeted Therapies in HER2-Positive
Gastric Adenocarcinoma. Cancer Biotherapy &
Radiopharmaceuticals. 2017;32 (10).
- American Cancer Society. Stomach Cancer: Early Detection,
Diagnosis, and Staging. Available at:
https://www.cancer.org/cancer/stomach-cancer/detection-diagnosis-staging/survival-rates.html.
- American Cancer Society. Stomach Cancer: Treating Stomach
Cancer. Available at:
https://www.cancer.org/cancer/stomach-cancer/treating/targeted-therapies.html.
- ENHERTU® [fam-trastuzumab deruxtecan-nxki] US prescribing
information; 2021.
- Shitara, K et al. Trastuzumab Deruxtecan in Previously Treated
HER2-Positive Gastric Cancer. N Engl J Med. 2020;382(25):2419-2430.
DOI: 10.1056/NEJMoa2004413.
- Global Cancer Observatory. Cancer Today. Lyon, France:
International Agency for Research on Cancer. Available at:
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf
.
- American Cancer Society. Stomach Cancer: About Stomach Cancer.
Available at:
https://www.cancer.org/cancer/stomach-cancer/about/key-statistics.html.
- NCCN Guidelines® Gastric Cancer. Version 4.2019. December 20,
2019: MS-22-36.
US-49031 Last Updated: 1/2021
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210118005073/en/
Media Inquiries Michele Meixell +1 302 885 2677 Brendan
McEvoy +1 302 885 2677
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Feb 2024 to Mar 2024
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Mar 2023 to Mar 2024