AstraZeneca will present new developments in pursuit of its ambition to eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, 19 to 21 September.

AstraZeneca medicines and pipeline molecules feature in 114 abstracts at ESMO, a record for the Company, including 20 oral presentations and two Presidential Symposia. The data highlight the breadth of the portfolio of cancer medicines and the early-stage pipeline. Whether it is by treating cancer early or by developing tailored medicines across all stages of disease, these data have the potential to transform patient outcomes and survival.

• Practice-changing overall survival (OS) data from the PROfound Phase III trial presented in a Presidential Symposium confirming the long-term benefit of Lynparza (olaparib) in biomarker-selected patients with metastatic castration-resistant prostate cancer (mCRPC)
• Exploratory data from the ADAURA Phase III trial showing further support for the unprecedented patient benefit of Tagrisso (osimertinib) in the adjuvant treatment of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) also presented in a Presidential Symposium
• Data from the PACIFIC Phase III trial in unresectable Stage III NSCLC and the CASPIAN Phase III trial in extensive-stage small-cell lung cancer (ES-SCLC), two late-breaking presentations strengthening the Company's leadership in the treatment of lung cancer

José Baselga, Executive Vice President, Oncology R&D, said: "The data being presented at ESMO will reshape clinical practice in the months and years ahead. The final PROfound overall survival data show the power of biomarker-directed medicines in prostate cancer, while the ADAURA and PACIFIC data reflect our continued focus on early detection, interception and treatment of cancer. We continue to work with urgency throughout this extraordinary period to accelerate the development of medicines in our pipeline, turning innovative science into improved outcomes for patients."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Our data at ESMO reflect our vision to transform the cancer treatment landscape, achieving more durable outcomes, treating with curative intent, and changing what it means to live with and beyond a cancer diagnosis. Our ability to detect and treat cancer early is key in bringing new treatment options to later stages of disease. We are eager to translate our pivotal research into clinical practice and help patients live better, longer lives."

Redefining treatment options for advanced disease across tumour types

One Presidential Symposium will present the final OS analysis of the PROfound Phase III trial of Lynparza versus enzalutamide or abiraterone in patients with mCRPC and homologous recombination repair (HRR) gene mutations, including BRCA, ATM, CDK12 and 11 other HRR genes.

Beyond the PROfound trial, a presentation of five-year follow-up data from the SOLO-1 Phase III trial will highlight the sustained progression-free and recurrence-free survival benefits of Lynparza for patients with newly diagnosed BRCA-mutated advanced ovarian cancer. These exploratory analyses are the longest follow-up for any PARP inhibitor in this setting and expand on the positive SOLO-1 results previously published in The New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa1810858) and presented at the ESMO 2018 Congress.

In addition, a late-breaking presentation of data from the PAOLA-1 Phase III trial will demonstrate that the addition of maintenance Lynparza to bevacizumab, a standard treatment, significantly improved the time to second disease progression (PFS2) compared with bevacizumab alone in patients with advanced ovarian cancer with homologous recombination deficiency positive status (defined by BRCA mutation and/or genomic instability). PFS2 is a key secondary endpoint in the PAOLA-1 trial and reinforces the positive results previously published in The New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/nejmoa1911361) and presented at the ESMO 2019 Congress.

Leadership in early lung cancer treatment

A second Presidential Symposium will present exploratory data from the ADAURA Phase III trial highlighting the impact of treatment with Tagrisso on sites and types of disease recurrence, including brain metastases, in patients with early-stage (Stages IB-IIIA) EGFRm NSCLC. Tagrisso was recently granted Breakthrough Therapy Designation (https://www.astrazeneca.com/media-centre/press-releases/2020/tagrisso-us-btd-for-egfrm-adjuvant-lung-cancer.html) in this setting in the US.

Data will also be presented from the PACIFIC and CASPIAN Phase III trials highlighting the long-term benefit of Imfinzi across different types of lung cancer. These include a presentation of four-year OS data in patients with unresectable Stage III NSCLC who had not progressed following concurrent chemoradiation therapy and a presentation of updated data in ES-SCLC.

Progressing the pipeline - pushing boundaries, advancing combinations

Exploratory data from the DESTINY-Gastric01 Phase II trial will show the results of Enhertu (trastuzumab deruxtecan) in patients with metastatic gastric cancer and low expression of HER2.

The DANUBE Phase III trial will be presented in an oral presentation showing the results for Imfinzi with and without tremelimumab in patients with advanced bladder cancer, including analyses of patients with high PD-L1 expression. The trial did not meet its primary endpoints.

• A Phase II trial of Lynparza plus Imfinzi and bevacizumab (MEDIOLA): initial results in patients with non-germline BRCA-mutated platinum sensitive relapsed ovarian cancer
• A Phase lb expansion trial of adavosertib plus Lynparza in patients with ES or relapsed SCLC

Collaboration in the scientific community is critical to improving outcomes for patients. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. in the US and Canada). AstraZeneca is collaborating with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialise Enhertu.

Key AstraZeneca presentations during the ESMO Virtual Congress 2020[1]

Lead author Abstract title Presentation details
Immuno
-Oncology
Goldman, J Durvalumab (D) ± Abstract #LBA86Mini Oral Session - Non
tremelimumab (T) + -metastatic NSCLC and other thoracic
platinum-etoposide malignancies
(EP) in 1L ES-SCLC:
Characterization of
long-term clinical
benefit and tumour
mutational burden
(TMB) in CASPIAN
Faivre-Finn, Durvalumab after Abstract #LBA49Mini Oral Session - Non
C chemoradiotherapy -metastatic NSCLC and other thoracic
in Stage III NSCLC: malignancies
4-year survival
update from the
Phase 3 PACIFIC
trial
Powles, T A phase 3, Abstract #697OProffered Paper Session -
randomized, open Genitourinary Tumours, Non-ProstateSaturday
-label study of September 1916:20 - 18:00 CESTChannel 3
first-line
durvalumab (D) with
or without
tremelimumab (T) vs
standard of care
chemotherapy in
patients with
unresectable,
locally advanced or
metastatic
urothelial
carcinoma (DANUBE)
DNA damage
response
Ray-Coquard, Maintenance Abstract #812MOMini Oral Session -
I olaparib + Gynaecological Cancers
bevacizumab (bev)
in patients (pts)
with newly
diagnosed advanced
high-grade ovarian
cancer (HGOC):
RECIST and/or CA
-125 objective
response rate (ORR)
in the Phase III
PAOLA-1 trial
Banerjee, S Maintenance Abstract #811MOMini Oral Session -
olaparib for Gynaecological Cancers
patients (pts) with
newly diagnosed,
advanced ovarian
cancer (OC) and a
BRCA mutation
(BRCAm): 5-year (y)
follow-up (f/u)
from SOLO1
Drew, Y Phase II study of Abstract #814MOMini Oral Session -
olaparib (O) plus Gynaecological Cancers
durvalumab (D) and
bevacizumab (B)
(MEDIOLA): initial
results in patients
(pts) with non
-germline BRCA
-mutated (non
-gBRCAm) platinum
sensitive relapsed
(PSR) ovarian
cancer (OC)
De Bono, J Final overall Abstract #610OPresidential Symposium
survival (OS) IISaturday 20 September19:14 - 19:26
analysis of CESTChannel 1
PROfound: olaparib
vs physician's
choice of
enzalutamide or
abiraterone in
patients (pts) with
metastatic
castration
-resistant prostate
cancer (mCRPC) and
homologous
recombination
repair (HRR) gene
alterations
Roubaud, G Tolerability of Abstract #624PE-Poster Display Session
olaparib (OLA) in
patients (pts) with
metastatic
castrationresistant
prostate cancer
(mCRPC) and
homologous
recombination
repair (HRR) gene
alterations:
PROfound
Agarwal, N Exploring the Abstract #622P E-Poster Display Session
impact of treatment
switching on the
interim overall
survival (OS)
results of the
PROfound study
Hauke, J Germline mutation Abstract #176PE-Poster Display Session
status and therapy
response in
patients with
homologous
recombination
deficient, HER2
-negative early
breast cancer:
Results of the
GeparOLA study
(NCT02789332)
Hochhauser, Assessing clinical Abstract #1527PE-Poster Display Session
D benefit of olaparib
maintenance
treatment in
subgroups of
patients with
germline BRCA
mutation (gBRCAm)
and metastatic
pancreatic cancer:
phase III POLO
trial
Li, B Phase Ib expansion Abstract #1785PE-Poster Display Session
study of
adavosertib plus
olaparib in
patients with
extensive-stage or
relapsed small-cell
lung cancer
Tumour
drivers and
resistance
Tsuboi, M Osimertinib Abstract #LBA1Presidential Symposium
adjuvant therapy in ISaturday, 19 September18:30 - 18:42
patients (pts) with CESTChannel 1
early stage EGFR
mutated (EGFRm)
NSCLC after tumour
resection (ADAURA):
sites of disease
recurrence
Planchard, D Osimertinib plus Abstract #1401PE-Poster Display Session
platinum/pemetrexed
in newly-diagnosed
EGFR mutation
(EGFRm)-positive
advanced NSCLC:
safety run-in
results from the
FLAURA2 study
Cheng, Y Osimertinib vs Abstract #1295PE-Poster Display Session
comparator EGFR-TKI
as first-line
treatment for EGFRm
advanced NSCLC:
FLAURA China study
overall survival
Subramanian, Epidermal growth Abstract #1402PE-Poster Display Session
J factor receptor
mutation (EGFRm)
testing in advanced
non-small cell lung
cancer (aNSCLC) in
a real-world
setting
Hummel, M FACILITATE: a real Abstract #1205PE-Poster Display Session
-world multicentre
prospective study
investigating the
utility of a rapid,
fully automated RT
-PCR assay vs
reference methods
(RM) for detecting
epidermal growth
factor receptor
mutations (EGFRm)
in NSCLC
Antibody
drug
conjugates
Yamaguchi, K Trastuzumab Abstract #1422MOMini Oral Session -
deruxtecan in Gastrointestinal tumours, non-colorectal
patients with
HER2low, advanced
gastric or
gastroesophageal
junction
adenocarcinoma:
results of the
exploratory cohorts
in the phase 2,
multicenter, open
label DESTINY
-Gastric01 study
Modi, S Artificial Abstract #286PE-Poster Display Session
intelligence
analysis of
advanced breast
cancer patients
from a phase I
trial of
trastuzumab
deruxtecan (T-DXd):
HER2 and
histopathology
features as
predictors of
clinical benefit
Powell, C Risk factors for Abstract #289PE-Poster Display Session
interstitial lung
disease in patients
treated with
trastuzumab
deruxtecan from two
interventional
studies
Janjigian, A phase 1b/2, Abstract #1500TiPE-Poster Display Session
YY multicenter, open
label, dose
escalation and dose
expansion study
evaluating
trastuzumab
deruxtecan
monotherapy and
combinations in
patients with HER2
overexpressing
gastric cancer
(DESTINY-Gastric03)

[1] 114 abstracts at ESMO 2020 include AstraZeneca medicines and pipeline molecules, of which 75 are company sponsored or supported.

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 personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, 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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