IMFINZI combinations show meaningful overall
survival in liver and biliary tract cancers
LYNPARZA combined with abiraterone will
demonstrate clinical benefit regardless of biomarker status in
metastatic castration-resistant prostate cancer
AstraZeneca will present new data in liver, biliary tract and
prostate cancers illustrating its ambition to revolutionize cancer
care at the 2022 American Society of Clinical Oncology
Gastrointestinal Cancers Symposium (ASCO GI) and the 2022 ASCO
Genitourinary Cancers Symposium (ASCO GU).
A total of 35 abstracts from AstraZeneca will be featured across
the two meetings. There will be two oral presentations at ASCO GI
taking place January 20 - 22, and an additional two oral
presentations at ASCO GU taking place February 17 - 19.
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, AstraZeneca, said: “There is an urgent need for new effective
treatment options to delay disease recurrence and improve survival
for patients with advanced liver, biliary tract and prostate
cancers. Our data for IMFINZI and LYNPARZA at these two meetings
will illustrate how AstraZeneca is extending the benefits of our
medicines into new areas where progress for patients has been
limited.”
Cristian Massacesi, Chief Medical Officer and Oncology Chief
Development Officer, AstraZeneca, said: “Our data will demonstrate
the potential of our medicines to transform patient outcomes in
liver, biliary tract and prostate cancers. Results from HIMALAYA
and TOPAZ-1 will underscore our commitment to improving long-term
survival for patients with liver and biliary tract cancers, and
data from PROpel will raise the bar in treating 1st-line metastatic
castration-resistant prostate cancer.”
Aiming to transform treatment of liver and biliary tract
cancers with immunotherapy combinations at ASCO GI A
late-breaking presentation will feature results from the HIMALAYA
Phase III trial showing a statistically significant and clinically
meaningful overall survival (OS) benefit with a single priming dose
of tremelimumab added to IMFINZI® (durvalumab) in 1st-line
unresectable liver cancer.
This trial used a novel dose and schedule called the STRIDE
(Single Tremelimumab Regular Interval Durvalumab) regimen. HIMALAYA
is the first Phase III trial to show that a dual immunotherapy
regimen has improved OS in this setting.
A second late-breaking presentation will highlight results from
the TOPAZ-1 Phase III trial for IMFINZI plus chemotherapy in
advanced biliary tract cancer, which was unblinded early at an
interim analysis in October 2021 due to clear evidence of
efficacy.
The combination demonstrated a statistically significant and
clinically meaningful OS benefit versus chemotherapy alone in
1st-line advanced biliary tract cancer, making it the first
immunotherapy combination to demonstrate superior clinical outcomes
over standard of care in a global, randomized trial in this
setting.
Also at the meeting, the first data from IMFINZI plus
bevacizumab in the Study 22 Phase II trial will provide the
efficacy and safety profile of this combination in unresectable
liver cancer. This regimen is being tested in the EMERALD-1 Phase
III trial of transarterial chemoembolization in combination with
IMFINZI alone and with bevacizumab in patients with locoregional
liver cancer, as well as in the EMERALD-2 Phase III trial with
liver cancer patients who are at high risk of recurrence after
curative hepatic resection or ablation.
Challenging the status quo in prostate cancer with an
industry-leading PARP inhibitor at ASCO GU A late-breaking
presentation will showcase the results from the PROpel Phase III
trial of LYNPARZA® (olaparib) plus abiraterone, which showed the
combination significantly delayed disease progression in 1st-line
metastatic castration-resistant prostate cancer (mCRPC) regardless
of biomarker status. LYNPARZA is the first PARP inhibitor to
demonstrate clinical benefit in combination with a new hormonal
agent in this setting.
Additionally, an oral presentation will feature the results of
the BAYOU Phase II trial evaluating the combination of LYNPARZA and
IMFINZI in unresectable, Stage IV bladder cancer. Data will show
comparable efficacy of IMFINZI monotherapy to that of other immune
checkpoint monotherapy data in similar trial populations and will
suggest additional research into a potential role for PARP
inhibition in subsets of patients with specific gene mutations.
Harnessing the potential of antibody drug conjugates across
HER2-targetable cancers At ASCO GI, data will include an encore
presentation of the OS results of the DESTINY-Gastric01 Phase II
trial of ENHERTU® (fam-trastuzumab deruxtecan-nxki) in
HER2-positive metastatic gastric and gastro-esophageal junction
adenocarcinoma (GEJA), and initial results from the
DESTINY-Gastric03 Phase Ib/II trial in HER2-positive gastric cancer
and GEJA.
In January 2021, ENHERTU became the first HER2-directed medicine
approved for patients with gastric cancer in a decade.
Additional ENHERTU data at ASCO GI will include encore results
from the DESTINY-CRC01 Phase II trial showing clinically meaningful
activity in HER2-positive unresectable and/or metastatic colorectal
cancer. The overall safety and tolerability profile of ENHERTU in
DESTINY-CRC01 was consistent with that seen in previously reported
ENHERTU trials. There are currently no medicines approved to
specifically treat HER2-positive colorectal cancer.
At ASCO GU, results will be shared from the primary analysis of
a Phase Ib trial of ENHERTU in combination with nivolumab in
HER2-expressing bladder cancer.
Collaboration in the scientific community is critical to
improving outcomes for patients. AstraZeneca is collaborating with
Merck & Co., Inc. (known as MSD outside the US and Canada) to
develop and commercialize LYNPARZA, and with Daiichi Sankyo Company
Limited to develop and commercialize ENHERTU.
Key AstraZeneca presentations during ASCO GI 2022
Lead author
Abstract title
Presentation details
Immuno-Oncology
Alfa-Abou, GK
Phase 3 randomized, open-label,
multicenter study of tremelimumab (T) and durvalumab (D) as
first-line therapy in patients (pts) with unresectable
hepatocellular carcinoma (uHCC): HIMALAYA.
Abstract Presentation 3
Oral Abstract Session B: Cancers of the
Pancreas, Small Bowel, and Hepatobiliary Tract
21 January 2022
17:07 – 17:17 ET
22:07 – 22:17 GMT
Oh, D-Y
A phase 3 randomized, double-blind,
placebo-controlled study of durvalumab in combination with
gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced
biliary tract cancer (BTC): TOPAZ-1.
Abstract Presentation 2
Oral Abstract Session B: Cancers of the
Pancreas, Small Bowel, and Hepatobiliary Tract
21 January 2022
16:45 – 16:55 ET
21:45 – 22:55 GMT
Wang, L
A phase 3 randomized, double-blind,
placebo-controlled, multicenter, global study of durvalumab with
and after chemoradiotherapy in patients with locally advanced,
unresectable esophageal squamous cell carcinoma: KUNLUN.
Trials in Progress Poster Session A:
Cancers of the Esophagus and Stomach and Other GI Cancers
Antibody drug conjugates
Yamaguchi, K
Trastuzumab deruxtecan (T-DXd; DS-8201) in
patients with HER2–positive advanced gastric or gastroesophageal
junction (GEJ) adenocarcinoma: Final overall survival (OS) results
from a randomized, multicenter, open-label, phase 2 study
(DESTINY-Gastric01).
Rapid Abstract Session A: Cancers of the
Esophagus and Stomach
Janjigian, YY
Dose-escalation and dose-expansion study
of trastuzumab deruxtecan (T-DXd) monotherapy and combinations in
patients (pts) with advanced/metastatic HER2+ gastric cancer
(GC)/gastroesophageal junction adenocarcinoma (GEJA):
DESTINY-Gastric03.
Poster Session A: Cancers of the Esophagus
and Stomach and Other GI Cancers
Meric-Bernstam, F
A phase 2, multicenter, open-label study
evaluating trastuzumab deruxtecan (T-DXd) for the treatment of
select human epidermal growth factor receptor 2 (HER2)-expressing
solid tumors (DESTINY-PanTumor02).
Trials in Progress Poster Session B:
Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Yoshino, T
Trastuzumab deruxtecan (T-DXd; DS-8201) in
patients (pts) with HER2-expressing metastatic colorectal cancer
(mCRC): Final results from a phase 2, multicenter, open-label study
(DESTINY-CRC01).
Rapid Abstract Session C: Cancers of the
Colon, Rectum, and Anus
Raghav, KPS
Trastuzumab deruxtecan in patients with
HER2-overexpressing locally advanced, unresectable, or metastatic
colorectal cancer (mCRC): A randomized, multicenter, phase 2 study
(DESTINY-CRC02).
Trials in Progress Poster Session C:
Cancers of the Colon, Rectum, and Anus
Key AstraZeneca presentations during ASCO GU 2022
Lead author
Abstract title
Presentation details
Immuno-Oncology
Rosenberg, JE
BAYOU: A phase II, randomized,
multicenter, double-blind, study of durvalumab (D) in combination
with olaparib (O) for the first-line treatment of
platinum-ineligible patients with unresectable, stage IV urothelial
carcinoma (UC).
Oral Abstract Session B: Urothelial
Carcinoma
18 February 2022
17:42 – 17:52 ET
22:42 – 22:52 GMT
Powles, T
A phase 3, randomized, open-label,
multicenter, global study of the efficacy and safety of durvalumab
(D) + tremelimumab (T) + enfortumab vedotin (EV) or D + EV for
neoadjuvant treatment in cisplatin-ineligible muscle-invasive
bladder cancer (MIBC) (VOLGA).
Trials in Progress Poster Session B:
Urothelial Carcinoma
DNA Damage Response
Saad, F
PROpel: Phase III trial of olaparib (ola)
and abiraterone (abi) versus placebo (pbo) and abi as first-line
(1L) therapy for patients (pts) with metastatic
castration-resistant prostate cancer (mCRPC).
Oral Abstract Session A: Prostate
Cancer
17 February 2022
16:00 – 16:10 ET
21:00 – 21:10 GMT
SELECT SAFETY INFORMATION FOR IMFINZI® (durvalumab)
Immune-mediated adverse reactions, which may be severe or fatal,
can occur in any organ system or tissue, including the following:
immune-mediated pneumonitis, immune-mediated colitis,
immune-mediated hepatitis, immune-mediated endocrinopathies,
immune-mediated dermatologic adverse reactions, immune-mediated
nephritis and renal dysfunction, and solid organ transplant
rejection. IMFINZI can cause severe or life-threatening
infusion-related reactions. Fatal and other serious complications
can occur in patients who receive allogeneic hematopoietic stem
cell transplantation (HSCT) before or after being treated with a
PD-1/PD-L1 blocking antibody.
Advise women not to become pregnant or breastfeed during
treatment with IMFINZI and for at least 3 months after the last
dose.
In the PACIFIC trial, the most frequent serious adverse
reactions reported in at least 2% of patients were pneumonitis or
radiation pneumonitis (7%) and pneumonia (6%). In the CASPIAN
trial, the most frequent serious adverse reactions reported in at
least 1% of patients were febrile neutropenia (4.5%), pneumonia
(2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%) and
COPD (1.1%).
Most common adverse reactions (≥20% of patients with
unresectable, Stage III NSCLC) were cough, fatigue,
pneumonitis/radiation pneumonitis, upper respiratory tract
infections, dyspnea, and rash. Most common adverse reactions (≥20%
of patients with extensive-stage SCLC) were, nausea,
fatigue/asthenia, alopecia.
The safety and effectiveness of IMFINZI have not been
established in pediatric patients.
Please see complete Prescribing Information, including
Patient Information
IMPORTANT SAFETY INFORMATION FOR ENHERTU® (fam-trastuzumab
deruxtecan-nxki)
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 5.4
mg/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.
SELECT SAFETY INFORMATION for LYNPARZA® (olaparib)
tablets LYNPARZA is associated with serious, potentially fatal
risks, including myelodysplastic syndrome/acute myeloid leukemia
(MDS/AML), pneumonitis. Additionally, serious, potentially fatal
risk of venous thromboembolic events has been reported with
LYNPARZA in mCRPC. LYNPARZA can also cause fetal harm.
US FDA-APPROVED INDICATIONS LYNPARZA is a poly
(ADP-ribose) polymerase (PARP) inhibitor indicated:
First-Line Maintenance BRCAm Advanced Ovarian Cancer For
the maintenance treatment of adult patients with deleterious or
suspected deleterious germline or somatic BRCA-mutated (gBRCAm or
sBRCAm) advanced epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in complete or partial response to
first-line platinum-based chemotherapy. Select patients for therapy
based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance HRD Positive Advanced Ovarian Cancer
in Combination with Bevacizumab In combination with bevacizumab
for the maintenance treatment of adult patients with advanced
epithelial ovarian, fallopian tube or primary peritoneal cancer who
are in complete or partial response to first-line platinum-based
chemotherapy and whose cancer is associated with homologous
recombination deficiency (HRD) positive status defined by
either:
- a deleterious or suspected deleterious BRCA mutation,
and/or
- genomic instability
Select patients for therapy based on an FDA-approved companion
diagnostic for LYNPARZA.
Maintenance Recurrent Ovarian Cancer For the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer, who are in complete
or partial response to platinum-based chemotherapy.
Advanced gBRCAm Ovarian Cancer For the treatment of adult
patients with deleterious or suspected deleterious germline
BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated
with 3 or more prior lines of chemotherapy. Select patients for
therapy based on an FDA-approved companion diagnostic for
LYNPARZA.
gBRCAm, HER2-Negative Metastatic Breast Cancer For the
treatment of adult patients with deleterious or suspected
deleterious gBRCAm, human epidermal growth factor receptor 2
(HER2)-negative metastatic breast cancer who have been treated with
chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
Patients with hormone receptor (HR)-positive breast cancer should
have been treated with a prior endocrine therapy or be considered
inappropriate for endocrine therapy. Select patients for therapy
based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance gBRCAm Metastatic Pancreatic
Cancer For the maintenance treatment of adult patients with
deleterious or suspected deleterious gBRCAm metastatic pancreatic
adenocarcinoma whose disease has not progressed on at least 16
weeks of a first-line platinum-based chemotherapy regimen. Select
patients for therapy based on an FDA-approved companion diagnostic
for LYNPARZA.
HRR Gene-mutated Metastatic Castration-Resistant Prostate
Cancer For the treatment of adult patients with deleterious or
suspected deleterious germline or somatic homologous recombination
repair (HRR) gene-mutated metastatic castration-resistant prostate
cancer (mCRPC) who have progressed following prior treatment with
enzalutamide or abiraterone. Select patients for therapy based on
an FDA-approved companion diagnostic for LYNPARZA.
Please click here for complete Prescribing Information,
including Patient Information (Medication Guide).
Notes
AstraZeneca in oncology AstraZeneca is leading a
revolution in oncology with the ambition to provide cures for
cancer in every form, following the science to understand cancer
and all its complexities to discover, develop and deliver
life-changing medicines to patients.
The Company’s focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyze changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
About AstraZeneca AstraZeneca is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialization of prescription medicines in
Oncology, Rare Diseases and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, 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.
US-60976 Last Updated 1/22
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Media Inquiries Brendan McEvoy +1 302 885 2677
Jessica McDuell +1 302 885 2677
US Media Mailbox: usmediateam@astrazeneca.com
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