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2017-05-26

AstraZeneca: AstraZeneca delivers new data on expanding portfolio of cancer medicines at 2017 American Society of Clinical ...

Lynparza's potential in BRCA-mutated metastatic breast cancer to be
highlighted in plenary presentation of Phase III OlympiAD trial

Key trials show further evidence of Tagrisso efficacy in patients with
EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) and
central nervous system (CNS) metastases (AURA3 trial) or
leptomeningeal disease (BLOOM trial)

New data demonstrate advances in Immuno-Oncology, including Imfinzi in
non-small cell lung and bladder cancer

AstraZeneca, along with its global biologics research and development
arm, MedImmune, will demonstrate how it is rapidly delivering on the
Company's science-led strategy for transformational cancer medicine
development at the 2017 American Society of Clinical Oncology (ASCO)
Annual Meeting in Chicago, US, 2-6 June 2017.

With three new oncology medicines addressing the unmet needs of
patients with ovarian, lung, and bladder cancers approved in under
three years, AstraZeneca is now halfway to delivering on its promise
to launch six new medicines for cancer by 2020.

This progress is reflected in the 100 company-sponsored and supported
abstracts, including five Best-of-ASCO presentations, 11 oral
presentations and eight poster discussions, accepted for the meeting.
These include new data on approved and potential new medicines from
the Company's pipeline across multiple scientific platforms and
tumour types.

Jamie Freedman, Executive Vice President, Oncology at AstraZeneca,
said: "2017 is a pivotal year for our oncology portfolio as global
launch and development programmes for Lynparza, Tagrisso and Imfinzi
gain momentum, with further pivotal data anticipated in the coming
months, in particular in 1st-line non-small cell lung cancer. We are
excited to demonstrate the strength of our rapidly-expanding
portfolio at ASCO, including the positive OlympiAD results for
Lynparza in BRCA-mutated metastatic breast cancer."

Growing confidence in DNA Damage Response (DDR) approach emphasised by
OlympiAD results

`Late-breaker' data from the OlympiAD trial of Lynparza (olaparib)
versus chemotherapy in BRCA-mutated metastatic breast cancer
(Abstract #LBA4) are the first positive Phase III results for a poly
ADP-ribose polymerase (PARP) inhibitor beyond ovarian cancer. They
are an important next step in the development of AstraZeneca's DDR
approach to selectively targeting of tumours through deficiencies in
cancer cell DNA repair mechanisms.

Additional Lynparza data will include:

·
SOLO-2: Oral presentation of Phase III data on the relationship
between health-related quality of life (HRQOL) and patient-centred
and clinical outcomes with Lynparza maintenance following
chemotherapy in patients with BRCA-mutated platinum-sensitive
relapsed serous ovarian cancer (Abstract #5507)

·
Study 19: Randomised Phase II overall survival and updated
progression-free survival data for the combination of Lynparza and
cediranib versus Lynparza alone in recurrent platinum-sensitive
ovarian cancer (Abstract #5535)

AstraZeneca's unique DDR pipeline will also be illustrated through an
oral presentation of Phase I data on the WEE1 inhibitor, AZD1775, in
combination with radiation therapy and temozolomide in patients with
newly-diagnosed glioblastoma multiforme (GBM) and evaluation of
intratumoural drug distribution in patients with recurrent GBM
(Abstract #2005). Additional information will also be presented from
a Phase I trial of AZD1775 in combination with neoadjuvant weekly
cisplatin and docetaxel in borderline-resectable head and neck
squamous cell carcinoma (HNSCC) (Abstract #6034).

Extended evidence of the effect of Tagrisso (osimertinib) on CNS
metastases

Latest Tagrisso data from the AURA3 trial to be released during an
oral presentation will provide further evidence of the response to
treatment in patients with epidermal growth factor receptor (EGFR)
T790M mutation-positive non-small cell lung cancer (NSCLC) and CNS
metastases (Abstract #9005).

Further insights into the ability of Tagrisso to cross the blood-brain
barrier will be provided through updated results from the BLOOM trial
of Tagrisso in patients with EGFR mutation-positive NSCLC and
leptomeningeal disease (Abstract #2020).

New data on Imfinzi (durvalumab) as monotherapy and in combination

Building on exciting recent milestones for its Immuno-Oncology
programme, AstraZeneca will be presenting updated data from the NSCLC
and bladder cancer cohorts of the Phase I/II Study 1108 of durvalumab
in patients with advanced solid tumours. New data in locally-advanced
or metastatic urothelial carcinoma (mUC) (Abstract #4525) reinforce
the May 2017 US FDA approval of Imfinzi for the treatment of patients
with locally advanced or mUC who have disease progression during or
following platinum-containing chemotherapy, or whose disease has
progressed within 12 months of receiving platinum-containing
chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

Updated durvalumab monotherapy Study 1108 results in Stage IIIB/IV
NSCLC (Abstract #9085) will also be presented. These data underline
AstraZeneca's forward momentum in lung cancer following the positive
top-line results of the Phase III PACIFIC trial of durvalumab as
sequential treatment in patients with locally-advanced, unresectable
(Stage III) NSCLC. In an oral presentation, MedImmune will present
data on a novel relationship in NSCLC between EGFR pathway activation
and the immunosuppressive molecule CD73 (Abstract #11505).

- ENDS -

NOTES TO EDITORS

AstraZeneca/MedImmune key presentations at the 2017 ASCO Annual
Meeting

Lead author Abstract title Presentation details

DNA Damage Response (DDR)

Robson ME OlympiAD: Oral Plenary Session Including the Science of
Phase III Oncology Award and Lecture Sunday 4th June, 13:00
Trial of -16:00 Presentation Time: 15:10-15:25 Location:
Olaparib Hall B1 Abstract #LBA4
Monotherapy
Versus
Chemotherapy
for Patients
with HER2
-Negative
Metastatic
Breast
Cancer and a
Germline
BRCA
Mutation
Friedlander Health Oral Gynecologic Cancer Friday 2nd June, 15:00
M -Related -18:00 Presentation Time: 17:12-17:24 Location:
Quality of S406 Abstract #5507
Life (HRQOL)
and Patient
-Centered
Outcomes
Support the
Clinical
Benefit of
Prolongation
of
Progression
-Free
Survival
with
Olaparib
Maintenance
Following
Chemotherapy
in Patients
with
Germline
BRCA-mutated
Platinum
-Sensitive
Relapsed
Serous
Ovarian
Cancer: SOLO
-2 Phase III
Trial
Liu JF Overall Poster Gynecologic Oncology Saturday 3rd June,
Survival and 13:15-16:45 Location: Hall A Abstract #5535 Poster
Updated #357
Progression
-Free
Survival
Results from
a Randomized
Phase II
trial
Comparing
the
Combination
of Olaparib
and
Cediranib
Against
Olaparib
Alone in
Recurrent
Platinum
-Sensitive
Ovarian
Cancer
Alexander Phase I Oral Central Nervous System Tumors Sunday 4th June,
BM study of 08:00-11:00 Presentation Time: 09:24-09:36
AZD1775 with Location: S100a Abstract #2005
Radiation
Therapy and
Temozolomide
in Patients
with Newly
Diagnosed
Glioblastoma
(GBM) and
Evaluation
of
Intratumoral
Drug
Distribution
in Patients
with
Recurrent
GBM
Mendez E A Phase I Poster Head and Neck Cancer Monday 5th June, 13:45
Clinical -16:45 Location: Hall A Abstract #6034 Poster #22
Trial of
AZD1775 in
Combination
with
Neoadjuvant
Weekly
Cisplatin
and
Docetaxel in
Borderline
Resectable
Head and
Neck
Squamous
Cell
Carcinoma

Tumour Drivers & Resistance

Garassino CNS Response Oral Lung Cancer - Non-Small Cell Metastatic
M to Osimertinib Tuesday 6th June, 09:45-12:45 Presentation Time:
in Patients 11:33-11:45 Location: Hall D1 Abstract #9005
with T790M
-Positive
Advanced Non
-Small Cell
Lung Cancer:
Data from a
Randomized
Phase III
Trial (AURA3)
Yang JC-H Osimertinib Poster Discussion Central Nervous System Tumors
for Patients Monday 5th June, 13:15-16:45 Discussion time: 16:45
with -18:00 Poster Location: Hall A Discussion Location:
Leptomeningeal S404 Abstract #2020 Poster #262
Metastases
from EGFR
-Mutant Non
-Small Cell
Lung Cancer:
Updated
Results from
the BLOOM
Study

Immuno-Oncology

Hahn NM Updated Poster Genitourinary (Nonprostate) Cancer Sunday
Efficacy and 4th June, 08:00 - 11:30 Location: Hall A Abstract
Tolerability #4525 Poster #203
of
Durvalumab
in Locally
Advanced or
Metastatic
Urothelial
Carcinoma
Balmanoukian Updated Poster Lung Cancer - Non-Small Cell Metastatic
A Safety and Saturday 3rd June, 08:00-11:30 Location: Hall A
Clinical Abstract #9085 Poster #411...

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