Data for datopotamab deruxtecan (DS-1062) and
ENHERTU® signal strong potential of these antibody drug conjugates
in advanced lung cancer
New non-small cell lung cancer data for
TAGRISSO® and IMFINZI® further demonstrate the impact of treating
patients in early stages of the disease
AstraZeneca will present new data from across the innovative
lung cancer portfolio at the IASLC 2020 World Conference on Lung
Cancer (WCLC), hosted by the International Association for the
Study of Lung Cancer, 28 to 31 January 2021.
Eleven AstraZeneca medicines and potential new medicines from
the pipeline feature in 39 abstracts showcasing the Company’s
leadership across different types and stages of lung cancer,
including eight oral presentations with two late breakers.
Presentations include:
- Updated data from the TROPION-PanTumor01 Phase I trial of
datopotamab deruxtecan (Dato-DXd; DS-1062) with additional
patients, supporting its potential to redefine treatment outcomes
in advanced non-small cell lung cancer (NSCLC) Datopotamab
deruxtecan is a novel trophoblast cell-surface antigen 2
(TROP2)-directedantibody drug conjugate (ADC)
- New data from the DESTINY-Lung01 Phase II trial highlighting
the potential of ENHERTU® (trastuzumab deruxtecan) in
HER2-expressing metastatic NSCLC, and data in metastatic
HER2-mutant (HER2m) NSCLC, two groups of patients for whom no
HER2-directed medicine is currently approved
- New analyses from the ADAURA Phase III trial featured in two
oral presentations reinforcing the unprecedented benefit of
TAGRISSO® (osimertinib) regardless of prior adjuvant chemotherapy
or disease stage in the adjuvant treatment of epidermal growth
factor receptor-mutated (EGFRm) NSCLC, and showing patients treated
with TAGRISSO maintained their quality of life
José Baselga, Executive Vice President, Oncology R&D, said:
“AstraZeneca is leading the next wave of precision-medicine
innovations in lung cancer that aim to change clinical practice and
ultimately alter the course of the disease. Our data at WCLC for
datopotamab deruxtecan and ENHERTU (trastuzumab deruxtecan)
illustrate the potentially transformative role next-generation
antibody drug conjugates may play in advanced non-small cell lung
cancer. New results for TAGRISSO and IMFINZI® (durvalumab) continue
to validate our strategy to treat patients earlier, as we progress
the science of identifying patients most likely to respond to
treatment.”
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: “AstraZeneca is committed to advancing early detection
and treatment of lung cancer - and the urgency to achieve this goal
has only increased during the pandemic, which has significantly
impacted cancer care for patients around the world. Our TAGRISSO
and IMFINZI data at WCLC show how we are driving progress in
early-stage lung cancer, while also pushing the scientific
boundaries in resistant and advanced disease to identify new
solutions for patients.”
Harnessing the emerging potential of ADCs to treat different
types of lung cancer
Updated data from the TROPION-PanTumor01 Phase I trial of the
novel ADC datopotamab deruxtecan will be featured in an oral
presentation, demonstrating early antitumor activity in patients
with advanced/metastatic NSCLC who had progressed on standard
treatment. Additionally, two presentations on the data from the
DESTINY-Lung01 Phase II trial will show results of ENHERTU patients
with NSCLC, including new data from the HER2-expressing cohort and
data from the HER2 mutant cohort.
Collaboration in the scientific community is critical to
improving outcomes for patients. AstraZeneca is collaborating with
Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and
commercialize ENHERTU and datopotamab deruxtecan globally.
Treating patients with NSCLC in early stages
A late-breaking analysis from the ADAURA Phase III trial will
underscore the practice-changing results for adjuvant TAGRISSO in
Stage IB-IIIA EGFRm NSCLC and show the disease-free survival
results for patients who had been treated with adjuvant
chemotherapy prior to TAGRISSO and those who were not by stage of
disease. A second exploratory analysis from the Phase III ADAURA
trial will highlight the impact of treatment with adjuvant TAGRISSO
on quality of life based on patient-reported outcomes. TAGRISSO was
recently approved in the adjuvant setting in the US.
The ongoing NeoADAURA Phase III trial testing the benefit of
treating patients with resectable EGFRm NSCLC with neoadjuvant
TAGRISSO will be highlighted in a poster presentation.
The MERMAID-1 Phase III trial testing IMFINZI in patients with
completely resected, Stage II and III NSCLC who show evidence of
minimal residual disease (MRD), will also be highlighted in a
poster. MERMAID-1 is an early-stage NSCLC Phase III trial
evaluating circulating tumor DNA measurements to monitor for MRD
and to identify patients at high risk of recurrence after surgery
who may benefit from intervention with immunotherapy.
Progressing research in advanced lung cancer
AstraZeneca will also present data from several trials exploring
targeted therapies and novel combinations for advanced lung cancer,
including:
- Additional data from the CASPIAN Phase III trial of IMFINZI in
extensive-stage small cell lung cancer (ES-SCLC) showing exposure
response and pharmacokinetics as well as exploratory analyses based
on extent of disease
- The biomarker-directed HUDSON Phase II platform trial of
IMFINZI in combination with LYNPARZA© (olaparib) and other novel
anti-cancer medicines, including danvatirsen (STAT3 antisense
oligonucleotide), ceralasertib (ATR inhibitor) and oleclumab
(anti-CD73), in patients with NSCLC who progressed on anti-PD(L)1
therapy
- The ODIN BM Phase I trial assessing TAGRISSO brain exposure in
patients with EGFRm NSCLC central nervous system (CNS)
metastases
- The TATTON Phase Ib trial of TAGRISSO plus savolitinib in
patients with EGFRm MET-overexpressed/amplified NSCLC
- A trial-in-progress update on the Phase I trial of TAGRISSO in
combination with patritumab deruxtecan (HER3-DXd; U3-1402) in
patients with locally advanced or metastatic EGFRm NSCLC
Key AstraZeneca presentations during WCLC 20201
Lead author
Abstract title
Presentation details
Immuno-Oncology
Reinmuth, N
First-line durvalumab plus
platinum-etoposide in ES-SCLC: exploratory analyses based on extent
of disease in CASPIAN
Abstract #P48.03
Poster: P48 – Small Cell Lung Cancer/NET –
Chemo – IO
28 January 2021
Zheng, Y
Population pharmacokinetics and
exposure-response with durvalumab plus platinum-etoposide in
ES-SCLC: Results from CASPIAN
Abstract #P48.21
Poster: P48 – Small Cell Lung Cancer/NET –
Chemo – IO 28 January 2021
Besse, B
HUDSON: An open-label, multi-drug,
biomarker-directed Phase II platform study in patients with NSCLC,
who progressed on anti-PD(L)1 therapy
Abstract #OA07.08
Oral Session: OA07 – Immuno-biology and
Novel Immunotherapeutics from Bench to Bed
30 January 2021 11:05-11:10 SGT
Besse, B
Immuno-modulatory effects of ceralasertib
in combination with durvalumab in NSCLC with progression on
anti-PD(L)1 treatment (HUDSON)
Abstract #P16.07
Poster: P16 – Immuno-biology and Novel
Immunotherapeutics (Phase I and Translational)
Peters, S
MERMAID-1: A Phase III study of adjuvant
durvalumab plus chemotherapy in resected NSCLC patients with MRD+
post-surgery
Abstract #P03.03
Poster: P03 – Early Stage/Localized
Disease – Clinical Trials in Progress 28 January 2021
Tumor drivers and resistance
Wu, Y-L
Postoperative chemotherapy use and
outcomes from ADAURA: osimertinib as adjuvant therapy for resected
EGFR mutated NSCLC
Abstract #OA06.04
Oral Session: OA06 – Updates on EGFR
Targeted Perioperative Therapy and Precision Adjuvant
Chemotherapy
29 January 2021
16:55-17:05 SGT
Majem, M
Patient-reported outcomes from ADAURA:
osimertinib as adjuvant therapy in patients with resected EGFR
mutated (EGFRm) NSCLC
Abstract #OA06.03
Oral Session: OA06 – Updates on EGFR
Targeted Perioperative Therapy and Precision Adjuvant
Chemotherapy
29 January 2021
16:45-16:55 SGT
Tsuboi, M
Neoadjuvant osimertinib with/without
chemotherapy vs chemotherapy for EGFR mutated resectable NSCLC:
neoADAURA
Abstract #P03.02
Poster: P03 – Early Stage/Localized
Disease – Clinical Trials in Progress 28 January 2021
Cho, BC
ORCHARD: A biomarker-directed Phase 2
platform study in pts with advanced EGFRm NSCLC progressing on
first-line osimertinib
Abstract #P76.27
Poster: P76 – Targeted Therapy –
Clinically Focused – EGFR 28 January 2021
Jänne, PA
Phase 1 study of patritumab deruxtecan
(HER3-DXd; U3-1402) in combination with osimertinib in patients
with locally advanced or metastatic EGFR-mutated NSCLC2
Abstract #P01.03
Poster: P01 – Antibody Drug Conjugates,
Novel Therapeutics and Cytotoxics 28 January 2021
Han, J-Y
Osimertinib+savolitinib in pts with EGFRm
MET-amplified/overexpressed NSCLC: Phase Ib TATTON parts B and D
final analysis
Abstract #FP14.03
Featured Poster Session: FP14 – Targeted
Therapy – Clinically Focused
28 January 2021
Ekman, S
A PET and MRI study exploring osimertinib
brain exposure and efficacy in EGFRm NSCLC CNS metastases
Abstract #P76.72
Poster: P76 – Targeted Therapy –
Clinically Focused – EGFR
28 January 2021
Antibody drug conjugates
Spira, A
Datopotamab deruxtecan (dato-DXd;
DS-1062), a TROP2 ADC, in patients with advanced NSCLC: updated
results of TROPION-PanTumor01 Phase 1 study3
Abstract #OA03.03
Oral Session: OA03 – Promising
Antibody-Drug Conjugate and Cytotoxic Therapy in NSCLC
29 January 2021
10:30-10:40 SGT
Nakagawa, K
Trastuzumab deruxtecan in
HER2-overexpressing metastatic non-small cell lung cancer: interim
results of DESTINY-Lung013
Abstract #OA04.05
Oral Session: OA04 – New Data from Rare
EGFR Alterations
29 January 2021
12:05-12:15 SGT
Smit, EF
Trastuzumab deruxtecan in HER2-mutated
metastatic non-small cell lung cancer (NSCLC): interim results of
DESTINY-Lung013
Abstract #MA11.03
Mini Oral Session: MA11 – Expanding
Targetable Genetic Alterations in NSCLC
31 January 2021
14:15-14:20 SGT
1 39 abstracts at WCLC 2020 will feature AstraZeneca medicines
and pipeline molecules, of which 24 are company-sponsored or
supported. 2 Trial collaboration with Daiichi Sankyo which
maintains exclusive rights to patritumab deruxtecan. 3 ENHERTU and
datapotamab deruxtecan are developed and commercialized in
collaboration with Daiichi Sankyo worldwide, except in Japan where
Daiichi Sankyo maintains exclusive rights.
U.S. FDA-APPROVED INDICATION for ENHERTU® (trastuzumab
deruxtecan)
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.
ENHERTU IMPORTANT SAFETY INFORMATION
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. In clinical studies, of the 234 patients with unresectable
or metastatic HER2-positive breast cancer treated with ENHERTU, 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).
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 prednisolone or
equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater),
permanently discontinue ENHERTU. Promptly initiate corticosteroid
treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg
prednisolone or equivalent). Upon improvement, follow by gradual
taper (e.g., 4 weeks).
Neutropenia
Severe neutropenia, including febrile neutropenia, can occur in
patients treated with ENHERTU. Of the 234 patients with
unresectable or metastatic HER2-positive breast cancer who received
ENHERTU, a decrease in neutrophil count was reported in 30% of
patients and 16% had Grade 3 or 4 events. Median time to first
onset was 1.4 months (range: 0.3 to 18.2). Febrile neutropenia was
reported in 1.7% of patients.
Monitor complete blood counts prior to initiation of ENHERTU and
prior to each dose, and as clinically indicated. Based on the
severity of neutropenia, ENHERTU may require dose interruption or
reduction. 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.
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. 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. Manage LVEF
decrease through treatment interruption. Permanently discontinue
ENHERTU if LVEF of <40% or absolute decrease from baseline of
>20% is confirmed. 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.
Adverse Reactions
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 adverse reactions (frequency ≥20%) were nausea
(79%), fatigue (59%), vomiting (47%), alopecia (46%), constipation
(35%), decreased appetite (32%), anemia (31%), neutropenia (29%),
diarrhea (29%), leukopenia (22%), cough (20%), and thrombocytopenia
(20%).
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%).
- 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 WARNING, and Medication Guide.
SELECT SAFETY INFORMATION FOR TAGRISSO® (osimertinib)
- There are no contraindications for TAGRISSO
- TAGRISSO is associated with several serious and sometimes fatal
adverse reactions, including interstitial lung disease
(ILD)/pneumonitis, QTc interval prolongation, cardiomyopathy,
keratitis, erythema multiforme and Stevens-Johnson syndrome,
cutaneous vasculitis, and embryo-fetal toxicity
- The most common (≥20%) adverse reactions, including lab
abnormalities, were leukopenia, lymphopenia, thrombocytopenia,
diarrhea, anemia, rash, musculoskeletal pain, nail toxicity,
neutropenia, dry skin, stomatitis, fatigue, and cough
For additional information, please refer to the complete
Important Safety Information.
INDICATIONS
- TAGRISSO is indicated as adjuvant therapy after tumor resection
in adult patients with non-small cell lung cancer (NSCLC) whose
tumors have epidermal growth factor receptor (EGFR) exon 19
deletions or exon 21 L858R mutations, as detected by an
FDA-approved test
- TAGRISSO is indicated for the first-line treatment of adult
patients with metastatic non-small cell lung cancer (NSCLC) whose
tumors have epidermal growth factor receptor (EGFR) exon 19
deletions or exon 21 L858R mutations, as detected by an
FDA-approved test
- TAGRISSO is indicated for the treatment of adult patients with
metastatic EGFR T790M mutation-positive NSCLC, as detected by an
FDA-approved test, whose disease has progressed on or after EGFR
tyrosine kinase inhibitor (TKI) therapy
For additional information, please see the complete
Prescribing Information, including Patient Information.
SELECT SAFETY INFORMATION FOR IMFINZI® (durvalumab)
Stage III:
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%).
The most common adverse reactions were cough, fatigue,
pneumonitis or radiation pneumonitis, upper respiratory tract
infections, dyspnea, and rash.
The safety and effectiveness of IMFINZI have not been
established in pediatric patients.
SCLC:
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 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%).
The most common adverse reactions (≥20%) were nausea,
fatigue/asthenia and alopecia. The safety and effectiveness of
IMFINZI have not been established in pediatric patients.
Please refer to the complete Important Safety Information and
the full Prescribing Information for important dosage modification
and management information specific to adverse reactions,
here.
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.
U.S. 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.
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 see complete Prescribing Information, including
Patient Information.
NOTES TO EDITORS
AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and
potential new medicines in late-stage development for the treatment
of different forms of lung cancer spanning different histologies,
several stages of disease, lines of therapy and modes of action.
AstraZeneca aims to address the unmet needs of patients with EGFRm
tumors as a genetic driver of disease, which occur in 10-15% of
NSCLC patients in the US and EU and 30-40% of NSCLC patients in
Asia, with the approved medicines gefitinib and TAGRISSO®
(osimertinib) and its ongoing LAURA, NeoADAURA and FLAURA2 Phase
III trials.1-3 AstraZeneca is committed to addressing tumor
mechanisms of resistance through the ongoing SAVANNAH and ORCHARD
Phase II trials, which test TAGRISSO in combination with
savolitinib, a selective inhibitor of c-MET receptor tyrosine
kinase, along with other potential new medicines.
The Company is also evaluating the potential of ADCs to improve
patient outcomes in tumors with targetable gene alterations,
including HER2m NSCLC which affects approximately 2-4% of patients
with NSCLC.4,5 ENHERTU® (trastuzumab deruxtecan), a HER2-directed
antibody drug conjugate, is in development for metastatic
non-squamous HER2-overexpressing or HER2m NSCLC including trials in
combination with other anticancer treatments. In addition, a broad
and comprehensive clinical development program is evaluating the
efficacy and safety of datopotamab deruxtecan (a TROP2-directed
ADC) across multiple TROP2 cancers, as both a monotherapy and in
combination with other anticancer treatments.
An extensive Immuno-Oncology (IO) development program focuses on
lung cancer patients without a targetable genetic mutation, which
represent up to three-quarters of all patients with lung cancer.6
IMFINZI® (durvalumab), an anti-PDL1 antibody, is in development for
patients with advanced disease (POSEIDON and PEARL Phase III
trials) and for patients in earlier stages of disease, including
potentially curative settings (MERMAID-1, MERMAID-2, AEGEAN,
ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase
III trials) both as monotherapy and in combination with
tremelimumab and/or chemotherapy. IMFINZI is also in development in
the NeoCOAST, COAST and HUDSON Phase II trials in combination with
potential new medicines from the early-stage pipeline, including
ENHERTU.
About 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, Tumor 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.
Reference
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a Polish, single institution study and systematic review of
European incidence. Int J Clin Exp Pathol. 2013;6:2800-12.
- Keedy VL, et al. American Society of Clinical Oncology
provisional clinical opinion: epidermal growth factor receptor
(EGFR) mutation testing for patients with advanced non-small-cell
lung cancer considering first-line EGFR tyrosine kinase inhibitor
therapy. J Clin Oncol. 2011;29:2121-27.
- Ellison G, et al. EGFR mutation testing in lung cancer: a
review of available methods and their use for analysis of tumor
tissue and cytology samples. J Clin Pathol. 2013;66:79-89.
- Campbell JD, et al. Distinct patterns of somatic genome
alterations in lung adenocarcinomas and squamous cell carcinomas.
Nat Genet. 2016;48(6):607-16.
- Li BT, et al. HER2 amplification and HER2 mutation are distinct
molecular targets in lung cancers. J Thorac Oncol. 2016;11(3):
414-419.
- Pakkala, S, et al. Personalized therapy for lung cancer:
striking a moving target. JCI Insight. 2018;3(15):e120858.
US-49317 Last Updated 1/21
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