AstraZeneca will unveil new developments across a range of stages and subtypes of breast cancer at the 2020 San Antonio Breast Cancer Symposium (SABCS), which will be held virtually from 8 to 11 December 2020.

• New data from the DESTINY-Breast01 Phase II trial, which reinforce the durable efficacy seen with Enhertu (trastuzumab deruxtecan) in HER2-positive metastatic breast cancer following two or more prior anti-HER2 based regimens

• New results from the SERENA-1 Phase I trial, which demonstrate strong efficacy and safety for a next-generation oral selective oestrogen receptor degrader (SERD), AZD9833 as a monotherapy and in combination with the CDK4/6 inhibitor, palbociclib, in HR-positive, HER2-negative advanced breast cancer

José Baselga, Executive Vice President, Oncology R&D, said: "We are committed to transforming outcomes for women diagnosed or living with breast cancer by advancing a new generation of promising potential new medicines. The updates from the comprehensive DESTINY breast programme reflect the potential of Enhertu to help a wide range of breast cancer patients, while the encouraging data from the SERENA-1 Phase I trial paves the way for a clinical development programme to help patients with hormone receptor-positive disease."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Significant progress has been made to improve outcomes for those living with breast cancer but there is still much work to be done. At SABCS 2020, our dedication to transforming the lives of those living with breast cancer will be front and centre. With new updates from six different approved and potential new medicines, we are directly addressing patients' greatest unmet needs and are potentially redefining treatment. Additionally, we are making an impact through collaborations with the scientific community to accelerate innovation."

New, longer-term data from DESTINY-Breast01 to be presented at SABCS will highlight the updated efficacy and safety profiles of Enhertu in patients with previously treated HER2-positive metastatic breast cancer with an additional 9.4 months of follow up.

Furthermore, AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) will showcase several TiP abstracts that highlight how the companies are building on the impressive results of Enhertu in patients with HER2-positive metastatic breast cancer. These include trials to explore the potential of Enhertu in earlier lines of treatment and stages of disease and in new breast cancer settings, including patients with low levels of HER2 expression. They also include combinations with other anti-cancer medicines such as paclitaxel, Faslodex, Imfinzi and the potential new medicine capivasertib, an AKT inhibitor.

AstraZeneca will present new efficacy and safety results from the dose escalation and expansion cohort of SERENA-1, a Phase I clinical trial of next-generation oral SERD AZD9833 as a monotherapy and in combination with the CDK4/6 inhibitor palbociclib in women with HR-positive breast cancer.

Building on the updated SERENA-1 findings, the Company will present two Phase II trial-in-progress (TiP) abstracts for the potential new medicine AZD9833, evaluating its efficacy and safety in previously treated post-menopausal women with advanced breast cancer and its biological effects in women with treatment-naïve early-stage breast cancer.

AstraZeneca is also presenting real-world evidence to understand outcomes for patients with germline BRCA mutations, and treatment patterns among patients with HER2-positive metastatic breast cancer. The Company will also showcase data on the potential role of artificial intelligence and digital pathology in measuring levels of HER2 expression in patients with breast cancer.

Additionally, AstraZeneca recognises the important role of externally sponsored scientific research (ESR) in expanding the medical and scientific understanding of the Company's medicines, and in identifying associated areas of unmet need in breast cancer. More than half of the AstraZeneca abstracts at this year's SABCS are ESR trials with AstraZeneca medicines across various subtypes of breast cancer.

Abstracts to be presented at 2020 SABCS featuring AstraZeneca medicines and potential new medicines include:*

[][][]
Abstract title Lead Abstract details
author
Enhertu
(trastuzumab
deruxtecan)[1 ]
Updated results Modi S PD3-06Spotlight Poster-Discussion 3 - Advances
from DESTINY in HER2 Positive DiseaseDate: Wednesday,
-Breast01, a December 9, 2020Time: 6:30-7:45pm CT
phase 2 trial of
trastuzumab
deruxtecan (T
-DXd) in HER2
positive
metastatic breast
cancer
Trastuzumab Hamilton PD3-07 Spotlight Poster-Discussion 3 - Advances
deruxtecan (T E in HER2 Positive Disease;Date: Wednesday,
-DXd; DS-8201) December 9, 2020Time: 6:30-7:45pm CT
with nivolumab in
patients with
HER2-expressing,
advanced breast
cancer: a 2-part,
phase 1b,
multicenter, open
-label study
Novel approach to Gustavson PD6-01Spotlight Poster-Discussion 6 - Novel
HER2 M Approaches to Pathology and ImagingDate:
quantification: Thursday, December 10, 2020Time: 3:30-4:45pm CT
digital pathology
coupled with AI
-based image and
data analysis
delivers
objective and
quantitative HER2
expression
analysis for
enrichment of
responders to
trastuzumab
deruxtecan (T
-DXd; DS-8201),
specifically in
HER2-low patients
A real-world Collins J PS7-82Poster Session 7 - Epidemiology Date:
evidence study of Wednesday, December 9, 2020Time: 8:00am CT
treatment
patterns among
patients with
HER2-positive
metastatic breast
cancer
Solti-1804 HER2 Prat A OT-03-07Ongoing Trials Posters - Antibody-drug
-PREDICT: A ConjugatesDate: Wednesday, December 9, 2020Time:
biomarker 8:00am CT
research study of
DS8201-A-U301
-U302 and -U303
Trials [TiP]*
Trastuzumab Geyer Jr OT-03-01Ongoing Trials Posters - Antibody-drug
deruxtecan (T CE ConjugatesDate: Wednesday, December 9, 2020Time:
-DXd; DS-8201) vs 8:00am CT
trastuzumab
emtansine (T-DM1)
in high-risk
patients with
HER2-positive,
residual,
invasive early
breast cancer
after neoadjuvant
therapy: A
randomized, phase
3 trial (DESTINY
-Breast05) [TiP]
Trastuzumab Bardia A OT-03-09Ongoing Trials Posters -  Antibody-drug
deruxtecan (T ConjugatesDate: Wednesday, December 9, 2020Time:
-DXd; DS-8201) vs 8:00am CT
investigator's
choice of
chemotherapy in
patients with
hormone
receptor-positive
(HR+), HER2 low
metastatic breast
cancer whose
disease has
progressed on
endocrine therapy
in the metastatic
setting: A
randomized,
global phase 3
trial
(DESTINYBreast06)
[TiP] 
Trastuzumab Andre F OT-03-04Ongoing Trials Posters - Antibody-drug
deruxtecan (T ConjugatesDate: Wednesday, December 9, 2020Time:
-DXd; DS-8201) 8:00am CT
combinations in
patients with
HER2-positive
advanced or
metastatic breast
cancer: a phase
1b/2 open-label,
multicenter, dose
-finding and dose
-expansion study
(DESTINY
-Breast07) [TiP]
Trastuzumab Jhaveri K OT-03-05Ongoing Trials Posters - Antibody-drug
deruxtecan (T ConjugatesDate: Wednesday, December 9, 2020Time:
-DXd; DS-8201) in 8:00am CT
combination with
other anticancer
agents in
patients with
HER2-low
metastatic breast
cancer: a phase
1b, open-label,
multicenter, dose
-finding and dose
-expansion study
(DESTINY
-Breast08) [TiP]
Lynparza
(olaparib)[2]
Real-world Miller RS PS7-66Poster Session 7 - Epidemiology Date:
clinical outcomes Wednesday, December 9, 2020Time: 8:00am CT
of patients with
BRCA-mutated
(BRCAm) HER2
-negative
metastatic breast
cancer: A
CancerLinQ[®]
study
DOLAF- An Guiu S OT-13-05Ongoing Trials Posters -
international ImmunotherapyDate: Wednesday, December 9,
multicenter phase 2020Time: 8:00am CT
II trial of
durvalumab
(MEDI4736) plus
OLAparib plus
Fulvestrant in
metastatic or
locally advanced
ER-positive, HER2
-negative breast
cancer patients
selected using
criteria that
predict
sensitivity to
olaparib*
Ceralasertib Dean E PS11-18Poster Session 11 - Systemic Therapies II
(cer) in - NewDate: Wednesday, December 9, 2020Time:
combination with 8:00am CT
olaparib (ola) in
patients (pts)
with advanced
breast cancer
(BC): Results of
Phase I expansion
cohorts
Faslodex
(fulvestrant)
Validation of a Ellis MJ PD2-10Spotlight Poster Discussion 2 - Refining
predictive model Targeted Therapy in HR+ DiseaseDate: Wednesday,
for potential December 9, 2020Time: 5:15-6:30pm CT
response to
neoadjuvant
endocrine therapy
(NET) in
postmenopausal
women with
clinical stage II
or III Estrogen
Receptor positive
(ER+) and HER2
negative (HER2-)
breast cancer
(BC): An
ALTERNATE trial
analysis.
(Alliance
A011106)*
Neoadjuvant Ma CX GS4-05General Session 4 Date: Friday, December
chemotherapy 11, 2020Time: 9:45-10:00am ET
(NCT) response in
postmenopausal
women with
clinical stage II
or III estrogen
receptor (ER+)
positive and HER2
negative (HER2
-)breast cancer
(BC) resistant to
endocrine therapy
(ET) in the
ALTERNATE trial
(Alliance
A011106)*
Palbociclib (P) Perez PS10-17Poster Session 10 - Systemic Therapies I
in combination -Garcia - TargetedDate: Wednesday, December 9, 2020
with fulvestrant JM Time: 8:00am CT
(F) or letrozole
(L) in endocrine
-sensitive
patients (pts)
with hormone
receptor
(HR)[+]/HER2[-]
metastatic breast
cancer (MBC):
detailed safety
analysis from a
multicenter,
randomized, open
-label, phase II
trial (PARSIFAL)*
Serum thymidine Malorni L PS5-05Poster Session 5 - Response Prediction
kinase activity Biomarkers IIDate: Wednesday, December 9,
in patients with 2020Time: 8:00am CT
luminal
metastatic breast
cancer treated
with palbociclib
and fulvestrant
within the PYTHIA
trial*
GEICAM/2014-03 Jara C PS7-25Poster Session 7 EpidemiologyDate:
(Registem): A Wednesday, December 9, 2020Time: 8:00 AM CT
prospective
registry of
unresectable
locally advanced
or metastatic
breast cancer:
Characteristics
of a subset of
patients with
triple negative
subtype*
Evaluating serum Paoletti PS2-04Poster Session 2 - Markers, PathologyDate:
thymidine kinase I Wednesday, December 9, 2020Time: 8:00am CT
in hormone
receptor positive
metastatic breast
cancer patients
receiving first
line endocrine
therapy in the
SWOG S0226 trial*
Characteristics Alvarez I PS7-24Poster Session 7 - Epidemiology Date:
of HR+/HER2- Wednesday, December 9, 2020Time: 8:00am CT
patients with
recurrent disease
by HER2
expression from a
prospective
registry of
unresectable
locally advanced
or metastatic
breast cancer:
GEICAM/2014-03
(RegistEM)*
GEICAM/2014-03 Jara C PS7-35Poster Session 7 - Epidemiology Date:
(Registem): A Wednesday, December 9, 2020Time: 8:00am CT
prospective
registry of
advanced breast
cancer: a subset
of triple
negative breast
cancer patients
with her2 low
expression*
Characteristics Alvarez I PS7-08Poster Session 7 -Epidemiology Date:
of HR+/HER2- Wednesday, December 9, 2020Time: 8:00am CT
patients with
recurrent disease
from a
prospective
registry of
unresectable
locally advanced
or metastatic
breast cancer:
GEICAM/2014-03
(RegistEM)*
Assessment of Pascual J PS5-02Poster Session 5 - Response Prediction
early ctDNA Biomarkers IIDate: Wednesday, December 9,
dynamics to 2020Time: 8:00am CT
predict efficacy
of targeted
therapies in
metastatic breast
cancer: Results
from plasmaMATCH
trial*
Plk1 expression & Guerro PS2-01Poster Session 2 - Markers, PathologyDate:
efficacy of -Zotano A Wednesday, December 9, 2020Time: 8:00am
palbociclib in
advanced hormonal
receptor-positive
breast cancer
patients from
PEARL study
(GEICAM/2012-03)*
Mutational Guerro PS5-22Poster Session 5 - Response Prediction
profile from -Zotano A Biomarkers IIDate: Wednesday, December 9,
circulating tumor 2020Time: 8:00am CT
DNA in triple
negative breast
cancer: results
from the
prospective
registry of
unresectable
locally advanced
or metastatic
breast cancer
GEICAM/2014-03
(RegistEM)*
Targetable ERBB2 Alsaleem PS6-11Poster Session 6 - Prognostic FactorsDate:
mutation status M Wednesday, December 9, 2020Time: 8:00am CT
is an independent
marker of adverse
prognosis in
estrogen receptor
positive, ERBB2
non-amplified
primary lobular
breast carcinoma:
Validation using
a novel gene
signature of HER2
activation
AZD9833
Updated data from Baird R PS11-05Poster Session 11 - Systemic Therapies II
SERENA-1: A phase - NewDate: Wednesday, December 9, 2020Time:
1 dose escalation 8:00am CT
and expansion
study of the next
generation oral
SERD AZD9833 as a
monotherapy and
in combination
with palbociclib,
in women with ER
-positive, HER2
-negative
advanced breast
cancer
A randomised, Oliveria OT-09-02Ongoing Trials Posters - Endocrine
open-label, M TherapyDate: Wednesday, December 9, 2020Time:
parallel-group, 8:00am CT
multicentre phase
2 study comparing
the efficacy and
safety of oral
AZD9833 versus
fulvestrant in
women with
advanced ER
-positive HER2
-negative breast
cancer (SERENA-2)
[TiP]
A randomised, pre Robertson OT-09-05Ongoing Trials Posters - Endocrine
-surgical study J F R TherapyDate: Wednesday, December 9, 2020Time:
to investigate 8:00am CT
the biological
effects of
AZD9833 doses in
women with ER
-positive HER2
-negative primary
breast cancer
(SERENA-3) [TiP]

*Denotes ESR

AstraZeneca in breast cancer

Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need - with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation SERD and potential new medicine AZD9833. PARP inhibitor, Lynparza (olaparib) was the first targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease state. Building on the first approval of Enhertu, a HER2-directed antibody-drug conjugate, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy durvalumab in combination with other oncology medicines, including Lynparza and Enhertu, investigating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan (DS-1062).

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/Nasdaq: 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).

Contacts

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References

1. Enhertu is developed and commercialised in collaboration with Daiichi Sankyo worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights.
2. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. in the US and Canada).