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2021-12-03

AstraZeneca reinforces leadership in breast cancer at SABCS 2021 with new data underscoring ambition to redefine cancer care

Data from DESTINY-Breast03 will reaffirm the efficacy of Enhertu in treating HER2-positive metastatic breast cancer, including patients with stable brain metastases.
Extensive portfolio of nine approved and potential new medicines to be featured across subtypes and stages of disease, including data for novel combinations.

AstraZeneca will underscore its ambition to redefine care with new data from across its portfolio of innovative medicines at the 2021 San Antonio Breast Cancer Symposium (SABCS) 7-10 December 2021.

Fourteen AstraZeneca medicines and potential new medicines from the pipeline will be featured across 33 abstracts showcasing the Company's leadership across different types and stages of breast cancer, including three oral presentations.

Breast cancer is now the most diagnosed cancer worldwide with an estimated 2.3 million people diagnosed in 2020.[1]

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Continuing our year of breakthroughs in breast cancer, our data at SABCS will reinforce the practice-changing potential of Enhertu with new analyses from the DESTINY-Breast03 trial. Early data from the BEGONIA and TROPION-PanTumor01 trials demonstrate great promise in treating patients who have limited treatment options. These data build on our decades of experience in pioneering medicines to redefine care for patients."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Progress in breast cancer increasingly involves more personalised approaches to treating patients across subtypes and stages of disease, which is a key focus of our data at this year's SABCS. Our extensive knowledge of breast cancer disease biology and the patient experience fuel our ambition to deliver medicines that can truly revolutionise and reshape treatment for every type of breast cancer patient."

Transforming the treatment of advanced breast cancers with antibody drug conjugates (ADCs)

An oral presentation will share further results from a range of patient subgroups from the DESTINY-Breast03 Phase III trial, including those with stable brain metastases and patients characterised by hormone receptor status, number of prior lines of therapy or status of visceral metastasis.

Results from DESTINY-Breast03 demonstrated superior progression-free survival (PFS) for Enhertu (trastuzumab deruxtecan) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer previously treated with trastuzumab and a taxane.

In another oral presentation, updated results from the TROPION-PanTumor01 Phase I trial will continue to build promising evidence of the anti-tumour activity of datopotamab deruxtecan in patients with triple-negative breast cancer (TNBC).

Treating breast cancer early where there is more opportunity for cure

New data on patient quality of life from the OlympiA Phase III trial of Lynparza (olaparib) will be presented as an oral presentation.

These patient-reported outcomes data will provide compelling evidence that further supports Lynparza as a potential treatment option for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk HER2-negative early breast cancer.

The supplemental New Drug Application of Lynparza for this indication was recently granted Priority Review by the US Food and Drug Administration.

Changing the treatment landscape with next-generation medicines and novel combinations

A poster and spotlight poster discussion will share results from the BEGONIA Phase Ib/II trial testing Imfinzi (durvalumab) combinations in advanced/metastatic TNBC with data from arm 1 (Imfinzi plus paclitaxel), arm 2 (Imfinzi, paclitaxel and capivasertib) and arm 5 (Imfinzi, paclitaxel and oleclumab), which will further demonstrate the benefits of combining immune checkpoint inhibitors with other novel molecules.

Additionally, ongoing trials posters will share information about the ongoing SERENA-4 Phase III trial which evaluates our next-generation oral selective oestrogen receptor degrader (SERD) camizestrant (AZD9833) in combination with CDK4/6 inhibitors in the 1st-line treatment of patients with oestrogen receptor (ER)-positive, HER2-negative advanced breast cancer, and the SERENA-6 Phase III trial of camizestrant with CDK4/6 inhibitors in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer with an ESR1 mutation.

A further ongoing trial poster will share information on the CAPItello-292 Phase III trial, evaluating the benefit of adding capivasertib (an AKT inhibitor) to the treatment regimen of Faslodex (fulvestrant) and palbociclib in patients with HR-positive, HER2-negative locally advanced, unresectable or metastatic breast cancer.

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

Key AstraZeneca presentations during SABCS 2021

Lead author Abstract title Presentation details
Enhertu
(trastuzumab
deruxtecan)
Hurvitz S Trastuzumab Presentation GS3-01Oral - General Session 3 9
deruxtecan (T December, 202108:45 - 11:30 CT14:45 - 17:30 GMT
-DXd; DS
-8201a) vs.
trastuzumab
emtansine (T
-DM1) in
patients with
HER2+
metastatic
breast cancer
(mBC): results
of the
randomized
phase 3 study
DESTINY
-Breast03
Vaz Batista M Trastuzumab Publication PD4-06Spotlight Poster Discussion 4
deruxtecan in 8 December, 202117:00 - 18:30 CT23:00 - 00:30
patients with (+1) GMT
HER2[+] or
HER2
-low-expressing
advanced
breast cancer
and central
nervous system
involvement:
Preliminary
results from
the DEBBRAH
phase 2 study
[IIS]
Datopotamab
deruxtecan
(Dato-DXd)
Krop I Datopotamab Presentation GS1-05Oral presentation - General
deruxtecan Session 17 December, 202108:00 - 10:45 CT14:00
(Dato-DXd) in - 16:45 GMT
Advanced/Metast
atic Human
Epidermal
Growth Factor
Receptor 2
Negative
(HER2−) Breast
Cancer:
Results From
the Phase 1
TROPION
-PanTumor01
Study [J101
TNBC prelim
results]
Lynparza
(olaparib)
Ganz PA Quality of Presentation GS4-09Oral - General Session 410
life results December, 202108:45 - 11:15 CT14:45 - 17:15 GMT
from OlympiA:
A phase III,
multicenter,
randomized,
placebo
-controlled
trial of
adjuvant
olaparib after
(neo)-adjuvant
chemotherapy
in patients
with germline
BRCA1/2
mutations and
high risk HER
-2 negative
early breast
cancer
Imfinzi
(durvalumab)
Schmid P BEGONIA: Phase Publication PD10-03Spotlight Poster Discussion
1b/2 study of 10 9 December, 202117:00 - 18:30 CT23:00 -
durvalumab (d) 00:30 (+1) GMT
combinations
in locally
advanced/metast
atic triple
-negative
breast cancer
(TNBC):
Results from
arm 1 d +
paclitaxel
(p), arm 2 d +
p +
capivasertib
(c), and arm 5
d + p +
oleclumab (o)
Camizestrant
(AZD9833)
André F SERENA-4: A Publication OT2-11-06Ongoing Trials Poster
Phase III Session 29 December, 202117:00 - 18:30 CT23:00
comparison of - 00:30 (+1) GMT
AZD9833
(camizestrant)
plus
palbociclib,
versus
anastrozole
plus
palbociclib,
for patients
with ER
-positive/HER2
-negative
advanced
breast cancer
who have not
previously
received
systemic
treatment for
advanced
disease
Bidard FC SERENA-6: A Publication OT2-11-05Ongoing Trials Poster
Phase III Session 29 December, 202117:00 - 18:30 CT23:00
study to - 00:30 (+1) GMT
assess the
efficacy and
safety of
AZD9833
(camizestrant)
compared with
aromatase
inhibitors
when given in
combination
with
palbociclib or
abemaciclib in
patients with
HR+/HER2-
metastatic
breast cancer
with
detectable
ESR1m who have
not
experienced
disease
progression on
first-line
therapy
Faslodex
(fulvestrant)
and
capivasertib
Rugo HS CAPItello-292: Publication OT2-14-01Ongoing Trials Poster
A phase Ib/III Session 29 December, 202117:00 - 18:30 CT23:00
study of - 00:30 (+1) GMT
capivasertib,
palbociclib
and
fulvestrant,
versus
placebo,
palbociclib
and
fulvestrant,
for endocrine
therapy
-resistant
HR+/HER2−
advanced
breast cancer

Notes

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 and Zoladex and the next-generation oral SERD and potential new medicine camizestrant.

PARP inhibitor Lynparza is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD 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.

Building on the first approval of Enhertu, a HER2-directed ADC, 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 Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu, evaluating 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.

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 Cam...

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