Kurs & Likviditet
Beskrivning
Land | Storbritannien |
---|---|
Lista | Large Cap Stockholm |
Sektor | Hälsovård |
Industri | Läkemedel & Handel |
Results will further underscore efficacy and safety of Imfinzi, Tagrisso and Lynparza across multiple cancers with high unmet need.
Enhertu data will reinforce its transformative potential in HER2-targetable cancers.
New data for MEDI5752 will advance the science of next-generation immunotherapy.
AstraZeneca will present new data supporting its ambition to redefine cancer care at the European Society for Medical Oncology (ESMO) Congress 2022, 9 to 13 September 2022.
A total of 15 approved and potential new medicines from AstraZeneca will be featured across more than 75 abstracts in 13 tumour types.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "At ESMO this year, new evidence will demonstrate how our medicines are prolonging patient survival across several cancers. Data from the SOLO-1 and PAOLA-1 Phase III trials will reinforce the long-term survival benefits of PARP inhibition with Lynparza in advanced ovarian cancer, and new data for Imfinzi combinations in liver, biliary tract and lung cancers will show the potential to improve outcomes for patients in these areas of high unmet need."
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The momentum will continue for Enhertu at ESMO with new data across tumour types, including results from the DESTINY-Lung02 Phase II trial in HER2-mutant metastatic non-small cell lung cancer which formed the basis for the recent FDA approval. Additionally, we're excited to advance the science of CTLA-4 inhibition with new analyses presented from two Phase III trials of Imfinzi plus tremelimumab, HIMALAYA in liver cancer and POSEIDON in lung cancer, and for MEDI5752, our bispecific antibody targeting both PD-1 and CTLA-4 in lung cancer."
Transforming outcomes across tumours over time
Mature disease-free survival (DFS) data from the ADAURA Phase III trial will be featured in a late-breaking presentation detailing two years of additional follow-up in patients with early-stage (Stage IB-IIIA) EGFR-mutated non-small cell lung cancer (NSCLC) treated with adjuvant Tagrisso (osimertinib). Tagrisso is the only targeted treatment option approved in this setting. The presentation will also report updated results for patterns of recurrence and central nervous system DFS.
A late-breaking presentation will feature landmark five-year overall survival (OS) data from the externally sponsored PAOLA-1 Phase III trial of Lynparza (olaparib) in combination with bevacizumab in 1st-line advanced ovarian cancer, including patients with homologous recombination deficiency (HRD) positive disease. This is the longest follow up for a PARP inhibitor in combination with standard of care in this setting.
In addition, seven-year OS data from the SOLO1 Phase III trial of Lynparza for 1st-line maintenance therapy in BRCA-mutated (BRCAm) advanced ovarian cancer will be presented. This is the longest follow-up for any PARP inhibitor in newly diagnosed advanced ovarian cancer.
Data will also include updated OS results at two years from the TOPAZ-1 Phase III trial of Imfinzi (durvalumab) plus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line unresectable or advanced biliary tract cancer, as well as an analysis of immune-mediated adverse events. TOPAZ-1 is the first Phase III trial to show improved OS with an immunotherapy combination versus chemotherapy alone in this setting.
Extending the benefit of antibody drug conjugates (ADCs) to more patients
Several presentations will demonstrate the clinical potential of Enhertu (trastuzumab deruxtecan) treatment across HER2-targetable lung, gastric and breast cancers.
A late-breaking presentation will feature interim results from the DESTINY-Lung02 Phase II trial investigating Enhertu in patients with HER2-mutant (HER2m) metastatic NSCLC (mNSCLC) who have progressed following one or more systemic therapies. Enhertu was recently approved (https://www.astrazeneca.com/media-centre/press-releases/2022/enhertu-approved-in-us-for-her2-mutant-nsclc.html) in the US in this setting as the first HER2-directed treatment for these patients. Detailed data will also be shared from the DESTINY-Lung01 Phase II trial, both in this setting and in patients with HER2-overexpressing mNSCLC.
Another presentation will feature updated data from the DESTINY-Gastric02 Phase II trial in HER2-positive metastatic gastric cancer, the first Enhertu trial in Western patients with gastric cancer.
Data will also include a subgroup analysis of the DESTINY-Breast03 Phase III trial of Enhertu by disease history and prior treatments in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. Patient-reported outcomes from the DESTINY-Breast04 Phase III trial will also highlight quality of life data for patients treated with Enhertu in HER2-low unresectable and/or metastatic breast cancer. Enhertu was recently approved (https://www.astrazeneca.com/media-centre/press-releases/2022/enhertu-approved-in-the-us-for-her2-low-mbc.html) in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer based on this trial.
Additional posters will describe trials evaluating the TROP2-directed ADC datopotamab deruxtecan in patients with hormone-receptor positive, HER2-negative breast cancer (TROPION-Breast01 Phase III trial) and in a platform trial in combination with Tagrisso in patients with advanced NSCLC who have experienced disease progression (ORCHARD Phase II trial). There are currently no approved TROP2-directed therapies for patients in these settings.
Advancing the science of CTLA-4 inhibition
A new analysis from the positive HIMALAYA Phase III trial will show the impact of viral aetiology on outcomes in unresectable liver cancer for patients treated with a single priming dose of tremelimumab, an anti-CTLA-4 antibody, added to Imfinzi (STRIDE regimen).
In addition, a poster will describe the EMERALD-3 Phase III trial evaluating tremelimumab added to Imfinzi and transarterial chemoembolisation with or without lenvatinib in unresectable liver cancer patients eligible for embolisation.
A late-breaking presentation of the positive POSEIDON Phase III trial in mNSCLC will feature four-year OS outcomes in patients treated with a limited course of tremelimumab added to Imfinzi plus chemotherapy.
Another late-breaking presentation will share initial data for MEDI5752 plus chemotherapy in patients with treatment-naïve Stage IIIB-IV non-squamous NSCLC. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4. Bispecific antibodies are a promising approach in immuno-oncology that combines the potential benefits of two medicines into one antibody without the increased toxicity seen with administration of two separate medicines.
Reinforcing the robust benefits of PARP inhibitors across a broad range of tumour types
In addition to data from PAOLA-1 and SOLO1, an oral presentation will share updated efficacy analyses across biomarker subgroups from the PROpel Phase III trial of Lynparza plus abiraterone in patients with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC) treated with the combination with or without homologous recombination repair (HRR) gene mutations. Lynparza is the first PARP inhibitor to demonstrate a significant improvement in radiographic progression-free survival in combination with abiraterone versus abiraterone alone in 1st-line mCRPC irrespective of biomarker status.
Additionally, final OS data will be presented from the MEDIOLA Phase II trial of Lynparza and Imfinzi in germline BRCAm platinum-sensitive relapsed ovarian cancer and from the OPINION Phase IIIB trial of Lynparza maintenance monotherapy in patients with platinum-sensitive relapsed ovarian cancer without a germline BRCA1/BRCA2 mutation.
Data will also include an extended OS analysis from the POLO Phase III trial of Lynparza in germline BRCA-mutated metastatic pancreatic cancer, a disease in which no other PARP inhibitor is approved.
Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and datopotamab deruxtecan, and with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.
Key AstraZeneca presentations during ESMO 2022
Lead author Abstract title Presentation details
Antibody
drug
conjugates
Goto, K Trastuzumab Presentation #LBA55Mini Oral
Deruxtecan (T Session11 September 202210:15am
-DXd) in Patients (CEST)
(Pts) With HER2
-Mutant
Metastatic Non
-Small Cell Lung
Cancer (NSCLC):
Interim Results
From the Phase 2
DESTINY-Lung02
Trial
Ueno, NT Patient-Reported Presentation #217OProffered Paper
Outcomes (PROs) Session11 September 20229:30am
From DESTINY (CEST)
-Breast04, a
Randomized Phase
3 Study of
Trastuzumab
Deruxtecan (T
-DXd) vs
Treatment of
Physician's
Choice (TPC) in
Patients (pts)
With HER2-Low
Metastatic Breast
Cancer (MBC)
Ku, GY Updated Analysis Presentation #1205MOMini Oral
of DESTINY Session10 September 20223:45pm
-Gastric02: a (CEST)
Phase 2 Single
-Arm Trial of
Trastuzumab
Deruxtecan (T
-DXd) in Western
Patients (Pts)
With HER2
-Positive (HER2+)
Unresectable/Metas
tatic
Gastric/Gastroesop
hageal Junction
(GEJ) Cancer Who
Progressed on or
After Trastuzumab
-Containing
Regimen
Cortés, J Subgroup Analysis Presentation #236Pe-Poster10
by Disease September 2022
History and Prior
Treatments of
Patients (pts)
With HER2
-Positive (HER2+)
Metastatic Breast
Cancer (MBC) From
DESTINY-Breast03,
a Randomized
Phase 3 Study of
Trastuzumab
Deruxtecan (T
-DXd) vs
Trastuzumab
Emtansine (T-DM1)
Li, BT Phase 2 Trial of Presentation #976Pe-Poster12
Trastuzumab September 2022
Deruxtecan (T
-DXd) in Patients
(Pts) With HER2
-Mutated (HER2m)
Metastatic Non
-Small Cell Lung
Cancer (NSCLC):
Registrational
Data From DESTINY
-Lung01
Bardia, A Datopotamab Presentation #274TiPTrial in
deruxtecan (Dato Progress10 September 2022
-DXd), a TROP2
antibody-drug
conjugate, vs
investigators'
choice of
chemotherapy
(ICC) in
previously
-treated,
inoperable or
metastatic
hormone-receptor
(HR) positive,
HER2-negative
(HR+/HER2-)
breast cancer:
TROPION-Breast01
De Langen, J ORCHARD platform Presentation #1188TiPTrial in
study: Progress12 September 2022
osimertinib +
datopotamab
deruxtecan (Dato
-DXd) cohort in
patients (pts)
with advanced
NSCLC (aNSCLC)
who have
progressed on
first-line (1L)
osimertinib
Immuno
-oncology
Johnson, ML. Durvalumab (D) ± Presentation #LBA59Mini Oral
tremelimumab (T) Session11 September 202211:05am
+ chemotherapy (CEST)
(CT) in 1L
metastatic (m)
NSCLC: overall
survival (OS)
update from
POSEIDON after
median follow-up
(mFU) of
approximately 4
years (y)
Ahn, MJ MEDI5752 or Presentation #LBA56Mini Oral
pembrolizumab (P) Session11 September 202210:20am
plus (CEST)
carboplatin/pemetr
exed (CP) in
treatment-naïve
(1L) non-small
cell lung cancer
(NSCLC): a Phase
1b/2 trial
Spicer, J Platform study of Presentation #929MOMini Oral
neoadjuvant Session12 September 20223:15pm
durvalumab (D) (CEST)
alone or combined
with novel agents
in patients (pts)
with resectable,
early-stage non
-small-cell lung
cancer (NSCLC):
pharmacodynamic
correlates and
circulating tumor
DNA (ctDNA)
dynamics in the
NeoCOAST study
Oh, DY Updated overall Presentation #56Pe-Poster12
survival (OS) September 2022
from the Phase 3
TOPAZ-1 study of
durvalumab (D) or
placebo (PBO)
plus gemcitabine
and cisplatin (+
GC) in patients
(pts) with
advanced biliary
tract cancer
(BTC)
Antonuzzo, L Immune-mediated Presentation #57Pe-Poster12
adverse event September 2022
(imAE) incidence,
timing and
association with
efficacy in the
Phase 3 TOPAZ-1
study of
durvalumab (D) or
placebo (PBO)
plus gemcitabine
and cisplatin (+
GC) in advanced
biliary tract
cancer (BTC)
Chan, LS Impact of viral Presentation #714Pe-Poster12
aetiology in the September 2022
Phase 3 HIMALAYA
study of
tremelimumab (T)
plus durvalumab
(D) in
unresectable
hepatocellular
carcinoma (uHCC)
Özgüroğlu, M Phase 3 trial of Presentation #971TiPTrial in
durvalumab Progress10 September 2022
combined with
domvanalimab
following
concurrent
chemoradiotherapy
(cCRT) in
patients with
unresectable
stage III NSCLC
(PACIFIC-8)
Abou-Alfa, A randomised Presentation #727TiPTrial in
GK Phase 3 study of Progress12 September 2022
tremelimumab (T)
plus durvalumab
(D) with or
without
lenvatinib
combined with
concurrent
transarterial
chemoembolisation
(TACE) versus
TACE alone in
patients (pts)
with locoregional
hepatocellular
carcinoma (HCC):
EMERALD-3
DNA damage
response
Ray-Coquard, Final overall Presentation #LBA29Proffered Paper
IL survival (OS) Session9 September 20222:00pm (CEST)
results from the
Phase III PAOLA
-1/ENGOT-ov25
trial evaluating
maintenance
olaparib (ola)
plus bevacizumab
(bev) in patients
(pts) with newly
diagnosed
advanced ovarian
cancer (AOC)
DiSilvestro, Overall survival Presentation #517OProffered Paper
P (OS) at 7-year Session9 September 20222:10pm (CEST)
(y) follow-up
(f/u) in patients
(pts) with newly
diagnosed
advanced ovarian
cancer (OC) and a
BRCA mutation
(BRCAm) who
received
maintenance
olaparib in the
SOLO1/GOG-3004
trial
Guo, C A Phase (Ph) I/II Presentation #454OProffered Paper
trial of the Session10 September 202211:15am
CXCR2 antagonist (CEST)
AZD5069 in
combination with
enzalutamide
(ENZA) in
patients (pts)
with metastatic
castration
resistant
prostate cancer
(mCRPC)
Saad, F Biomarker Presentation #1357OProffered Paper
analysis and Session11 September 20229:30am
updated results (CEST)
from the Phase
III PROpel trial
of abiraterone
(abi) and
olaparib (ola) vs
abi and placebo
(pbo) as first
-line (1L)
therapy for
patients (pts)
with metastatic
castration
-resistant
prostate cancer
(mCRPC)
Banerjee, S Phase II study of Presentation #529MOMini Oral
olaparib plus Session11 September 20225:00pm
durvalumab with (CEST)
or without
bevacizumab
(MEDIOLA): final
analysis of
overall survival
in patients with
non-germline BRCA
-mutated platinum
-sensitive
relapsed ovarian
cancer
Poveda Maintenance Presentation #531Pe-Poster11
Velasco, AM olaparib September 2022
monotherapy in
patients (pts)
with platinum
-sensitive
relapsed ovarian
cancer (PSR OC)
without a
germline
BRCA1/BRCA2
mutation (non
-gBRCAm): final
overall survival
(OS) results from
the OPINION trial
Hammel, P Extended overall Presentation #1298Pe-Poster12
survival results September 2022
from the POLO
study of active
maintenance
olaparib in
patients with
metastatic
pancreatic cancer
and a germline
BRCA mutation
Tumour
drivers and
resistance
Tsuboi, M Osimertinib as Presentation #LBA47Proffered Paper
adjuvant therapy Session11 September 20228:30am
in patients (pts) (CEST)
with resected
EGFR-mutated
(EGFRm) stage
IB-IIIA non-small
cell lung cancer
(NSCLC): updated
results from
ADAURA
Piotrowska, ELIOS: A Presentation #LBA53Proffered Paper
Z multicentre, Session11 September 20223:05pm
molecular (CEST)
profiling study
of patients (pts)
with epidermal
growth factor
receptor-mutated
(EGFRm) advanced
NSCLC treated
with first-line
(1L) osimertinib
Nakamura, A Final results and Presentation #982Pe-Poster12
biomarker September 2022
analysis of a
randomized phase
II study of
osimertinib plus
bevacizumab
versus
osimertinib
monotherapy for
untreated
patients with non
-squamous non
-small-cell lung
cancer harboring
EGFR mutations;
WJOG9717L study
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 catalyse 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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation 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. Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca).
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