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2019-05-16

AstraZeneca: AstraZeneca continues to redefine cancer treatment at the 2019 ASCO Annual Meeting

Data focused on breaking treatment boundaries, treating patients
earlier in their disease, and raising the bar for better outcomes

Presentations highlight Lynparza's benefit in PARP-mediated cancers
and Imfinzi's three-year overall survival in unresectable, Stage III
non-small cell lung cancer

AstraZeneca will present new research across an industry-leading
Oncology portfolio, including data for its transformational cancer
medicines Lynparza (olaparib) and Imfinzi (durvalumab) at the 2019
American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, US, 31 May to 4 June 2019.

In all, the Company will present 93 abstracts spanning multiple tumour
types, including 12 oral presentations with one plenary session and
four late-breakers. Highlights include:

· Late-breaking results from the Lynparza POLO trial, the first
positive Phase III trial of any PARP inhibitor in germline
BRCA-mutated (gBRCAm) metastatic pancreatic cancer, a devastating
diagnosis with critical unmet medical need. This is the first Phase
III trial to validate a targeted treatment in a biomarker-selected
population of pancreatic cancer.

· Results of the Phase III SOLO-3 trial highlighting the efficacy
for Lynparza monotherapy vs. standard-of-care chemotherapy in
treating patients with gBRCAm advanced ovarian cancer who had two or
more prior lines of treatment. This data underscores Lynparza's
clinical benefit irrespective of line of treatment for women with
BRCAm advanced ovarian cancer and the importance of knowing BRCA
status at diagnosis.

· Three-year overall survival (OS) data from the Phase III PACIFIC
trial providing new evidence of the long-term survival benefit for
Imfinzi in unresectable, Stage III non-small cell lung cancer (NSCLC)
in patients whose disease had not progressed following chemoradiation
therapy. Imfinzi is the only immunotherapy to demonstrate significant
OS benefits in this curative-intent setting, and this data reaffirms
the PACIFIC regimen as the standard of care for these patients.

Dave Fredrickson, Executive Vice President, Oncology, said:
"AstraZeneca continues to break traditional treatment boundaries
through new targeted approaches and the prioritisation of earlier
intervention. This year at ASCO, our data for Lynparza in
BRCA-mutated metastatic pancreatic cancer and for Imfinzi in
unresectable Stage III non-small cell lung cancer illustrate our
ambition to change medical practice for better patient outcomes."

Breaking treatment boundaries

AstraZeneca is committed to redefining disease treatment for patient
populations with unmet needs. This will be evidenced at the ASCO
meeting for patients with PARP-mediated tumours, HER2-low expressing
tumours, and AKT-mutated tumours.

The plenary presentation of results from the Phase III POLO trial will
detail the progression-free survival (PFS) and important clinical
benefit of Lynparza in patients with metastatic pancreatic cancer, a
population that has seen very little treatment progress over the past
40 years (Abstract #LBA4).

New data on Lynparza will also be shared in advanced ovarian cancer,
including the results of the Phase III SOLO-3 trial highlighting the
efficacy for Lynparza monotherapy vs. standard-of-care chemotherapy
in treating patients with gBRCAm advanced ovarian cancer who had two
or more prior lines of treatment (Abstract #5506).

Furthermore, the Phase II TOPARP-B trial, sponsored by the Institute
of Cancer Research (UK), will highlight the anti-tumour activity of
Lynparza in patients with heavily-pretreated metastatic
castration-resistant prostate cancer with DDR gene defects (Abstract
#5005). The Phase II GeparOLA trial, conducted by the German Breast
Group and German AGO-B Breast Study Group, will help define the
safety and efficacy of Lynparza, compared to platinum-based
chemotherapy, in the neoadjuvant setting in HER2-negative early
breast cancer and in patients with homologous recombination
deficiency (Abstract #506).

The design of the Phase III DESTINY-Breast04 trial evaluating
trastuzumab deruxtecan (DS-8201) in metastatic breast cancer with
HER2-low expressing tumours will be presented at this year's ASCO
meeting (Abstract #TPS1102). The antibody drug conjugate (ADC)
co-developed with Daiichi Sankyo has the potential to redefine breast
cancer treatment. Two publications in Lancet Oncology
(https://www.astrazeneca.com/media-centre/medical-releases/astrazeneca-an...)
recently highlighted the Phase I dose-expansion results for
trastuzumab deruxtecan in HER2-positive metastatic breast and gastric
cancers.

In addition, data will be presented from the Phase II FAKTION trial,
sponsored by Velindre NHS Trust, on the combination of the AKT
inhibitor capivasertib (AZD5363) plus Faslodex (fulvestrant) in
patients with relapsed metastatic oestrogen receptor (ER)-positive
breast cancer (Abstract #1005). AKT mutations occur across several
different cancers and may be a target for treatment tailored to
tumour genes rather than cancer types.

Treating patients earlier in their disease

AstraZeneca made a significant breakthrough in the treatment of NSCLC
beginning in 2017 with the Phase III PACIFIC trial demonstrating
unprecedented PFS and subsequently OS
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2...)
benefits for patients with unresectable, Stage III NSCLC treated with
Imfinzi vs. standard of care. At this year's ASCO meeting,
AstraZeneca will provide new evidence of the long-term survival
benefit of Imfinzi with a three-year OS update (Abstract #8526).

Sub-analysis presentations of Phase III data from SOLO-1, the only
trial of a PARP inhibitor to demonstrate improvement in PFS for women
with BRCAm advanced ovarian cancer as a 1st-line maintenance
treatment, will reinforce the potential of using Lynparza earlier in
the treatment pathway (Abstract #5539).

Raising the bar for better outcomes

New data from the Phase III FLAURA trial will explore clinical
outcomes associated with the detection of epidermal growth factor
receptor (EGFR) mutations in plasma at three or six weeks after
starting treatment with Tagrisso (osimertinib) (Abstract #9020). With
the presentation of the Phase II SAVANNAH trial design, AstraZeneca
will explain how it will explore the combination of Tagrisso and
savolitinib to potentially overcome MET-driven EGFR tyrosine kinase
inhibitor (TKI) resistance following Tagrisso treatment in
EGFR-mutated NSCLC (Abstract #TPS9119).

Despite recent therapeutic progress, platinum-resistant ovarian cancer
remains a therapeutic challenge. Results of a multicenter,
double-blind Phase II trial conducted by the Princess Margaret,
California, Chicago and Mayo Phase II Consortia will show for the
first time increased OS data with the Wee-1 inhibitor adavosertib
when associated with the antimetabolite medicine gemcitabine
(Abstract #5518).

A focus on haematology The diverse haematology pipeline aims to
deliver new

medicines in a range of blood cancers with critical unmet medical
needAstraZeneca has established haematology as one of its key areas of
focus.

At the ASCO meeting and the upcoming 24th Congress of the European
Hematology

Association (EHA), 13-16 June 2019, the Company will present long-term
trial

follow-up data showing the promising response rate, duration of
response and

safety profile of the Bruton's tyrosine kinase (BTK) inhibitor
Calquence

(acalabrutinib) in chronic lymphocytic leukaemia (CLL), including:
· Three-year results from the Phase Ib/II ACE-CL-003 trial
evaluating

Calquence and obinutuzumab in treatment-naïve and previously-treated
CLL

(Abstract #7500)
· 19-month results from the Phase II ACE-CL-208 trial of Calquence
in

patients with relapsed or refractory CLL intolerant to ibrutinib
(Abstract

#7530)
These data are part of a robust development programme that includes
two

pivotal clinical trials for Calquence in CLL with full data
anticipated in

2019: the Phase III ASCEND (ACE-CL-309) trial in relapsed or
refractory CLL,

which recently met its primary
endpoint
(https://www.astrazeneca.com/content/astraz/media-centre/press

-releases/2019/calquence-phase-iii-ascend-trial-met-primary-endpoint-at
-interim-analysis-in-relapsed-or-refractory-chronic-lymphocytic-leukaemia-and
-will-stop-early-07052019.html), and the ongoing Phase III ELEVATE-TN
(ACE-CL

-007) trial evaluating Calquence with and without obinutuzumab in
front-line

CLL.
Key AstraZeneca presentations at ASCO 2019

Lead author Abstract title Presentation details
Immuno
-Oncology
Gray, JE Three-year Abstract #8526Poster Board #282Poster Session
overall survival - Lung Cancer - Non-Small Cell Local
update from the -Regional/Small Cell/Other Thoracic
PACIFIC trial. CancersSunday 2 June, 8:00-11:00amHall A
Planchard, First subsequent Abstract #9054Poster Board #377Poster Session
D treatment after - Lung Cancer - Non-Small Cell Metastatic
discontinuation Sunday 2 June, 8:00-11:00amHall A
of durvalumab in
unresectable,
Stage III NSCLC
patients from
PACIFIC.
Rizvi, NA Blood tumor Abstract #9016Poster Board #339Poster
mutational burden Discussion - Lung Cancer - Non-Small Cell
(bTMB) and tumor Metastatic Sunday 2 June, 4:30-6:00pmHall D1
PD-L1 as
predictive
biomarkers of
survival in
MYSTIC: first
-line durvalumab
(D) ±
tremelimumab (T)
vs chemotherapy
(CT) in
metastatic (m)
NSCLC.
Garon, EB Patient-reported Abstract #9048Poster Board #371Poster
outcomes (PROs) Presentation - Lung Cancer - Non-Small Cell
with first-line Metastatic Sunday 2 June, 8:00-11:00amHall A
durvalumab (D) ±
tremelimumab (T)
vs chemotherapy
(CT) in
metastatic NSCLC:
results from
MYSTIC.
Bradley, JD PACIFIC-2: phase Abstract #TPS8573Poster Board #327aPoster
3 study of Presentation - Lung Cancer - Non-Small Cell
...

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