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2014-05-15

AstraZeneca: AstraZeneca to demonstrate the strength and rapid acceleration of its oncology pipeline at ASCO 2014

Preliminary data* released ahead of full data presentations at ASCO,
30 May-3 June

New data from AstraZeneca's investigational cancer medicines
demonstrate the rapid progression of its oncology pipeline. Over 40
scientific abstracts from AstraZeneca and its global biologics R&D
arm MedImmune will be featured at the 50th Annual Meeting of the
American Society of Clinical Oncology (ASCO) at the end of this
month.

Data will be reported for a number of innovative molecules in
different tumour types. Highlights include:

· In the MEDI4736 Phase I trial to date we have seen durable
clinical activity and acceptable safety for this investigational
anti-PD-L1 antibody.

· Data from the large Phase I study of AZD9291 has shown that it was
well tolerated and clinically active in patients with EGFR mutation
positive (EGFRm+) non-small cell lung cancer (NSCLC) who have
developed acquired resistance to EGFR tyrosine-kinase inhibitors
(TKIs).

· Encouraging efficacy data shown in a randomised Phase II study,
conducted by the US National Cancer Institute (NCI), investigating
the combination of PARP inhibitor olaparib and VEGF inhibitor
cediranib in high-grade serous ovarian cancer.

Briggs Morrison, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca said: "We
believe that our rich oncology pipeline has the potential to redefine
the way that cancer patients are treated. We continue to deliver on
our late stage assets and drive our scientific leadership in
oncology, as clearly demonstrated by the recent accelerated
development of key assets.

"The preliminary data made available today highlight our strength
across our three core areas of oncology research: immuno-oncology,
our focus on the genetic drivers of cancer and acquired resistance
and DNA damage repair. We are looking forward to the presentation of
the full data sets at ASCO."

Harnessing the potential of immuno-oncology

MedImmune is building a comprehensive immuno-oncology programme, with
MEDI4736 as one of the leading late stage assets. Data from the
ongoing MEDI4736 Phase I study to be presented at ASCO has to date
shown encouraging clinical activity and acceptable safety across a
range of tumour types.

The results of this Phase I study, coupled with the pre-clinical data
and validation of this target supported the accelerated development
of MEDI4736 into Phase III clinical trials. The late stage clinical
programme for MEDI4736 will evaluate the compound in NSCLC at
different stages of disease. Patients were recently randomised into
the Phase III PACIFIC study, which is investigating patients with
locally advanced unresectable NSCLC (Stage III) following
chemoradiation. A second Phase III study, ARCTIC, will investigate
MEDI4736 as monotherapy in patients with advanced or metastatic NSCLC
who have failed on two or more prior therapies, and planned in
combination with tremelimumab.

Data from an ongoing study exploring MEDI4736 in combination with
tremelimumab in lung cancer will be presented as part of a briefing
for analysts and investors in Chicago on 2 June 2014.

MedImmune is also exploring tremelimumab (anti- CTLA 4) in a pivotal
study for malignant mesothelioma, a patient population with a very
high unmet need. Updated Phase II data from an investigator initiated
trial exploring tremelimumab in malignant mesothelioma will be
available at ASCO.

"Immuno-oncology is developing at a rapid pace and redefining the
cancer treatment landscape. We are committed to realising the full
potential of this promising therapeutic approach," said Bahija
Jallal, Executive Vice President, MedImmune. "We believe that
combinations of immunotherapies, both with each other and with highly
targeted small molecules, will be the key to achieving the greatest
patient benefit. With the AstraZeneca and MedImmune combined
portfolio, we are uniquely positioned to explore this possibility and
have already initiated multiple combination studies with MEDI4736."

Two oral presentations and a poster highlights session will showcase
data from the Phase I study (abstract #3001 in patients with solid
tumours, abstract #3002, a multi-arm expansion study and abstract
#8021, a clinical activity and biomarker analysis of MEDI4736 in
patients with treatment-naïve or pre-treated NSCLC).

Targeted treatments in lung cancer

Despite the efficacy of currently approved TKIs, for patients who have
the EGFR mutation positive form of NSCLC, resistance to treatment is
a significant barrier to long term disease control. In approximately
half of these patients this resistance is caused by the secondary
mutation known as T790M and there are currently no therapies
specifically approved for them. AZD9291 is a highly selective,
irreversible inhibitor of both the activating sensitising EGFR
mutation (EGFRm+) and the activating resistance mutation, T790M,
while sparing the activity of wild type EGFR.

Updated data from the ongoing Phase I AURA study show that to date
AZD9291 is well tolerated and has demonstrated sustainable
anti-cancer activity in lung cancer patients whose tumours are EGFR
mutation positive and have become resistant to EGFR TKIs.
Specifically, the data from this trial demonstrate that patients with
EGFR T790M+ tumours have a higher overall response rate than patients
whose tumours have not acquired this resistance mutation. The data
will be presented as an oral abstract (abstract #8009) and was
selected from over 5,000 study abstracts for inclusion in the
official ASCO programme.

AZD9291 was recently granted Breakthrough Therapy Designation by the
US FDA for patients with metastatic EGFR T790M mutation-positive
NSCLC, whose disease has progressed following treatment with an EGFR
TKI. The Breakthrough designation allows AstraZeneca to expedite the
US development of AZD9291. AstraZeneca plans to begin Phase III
trials soon.

Driving the potential of combinations

Combination therapies have the potential to be one of the most
effective ways of treating cancer. Results from the NCI led Phase II
study investigating the combination of olaparib, a potential
first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor, and
cediranib, a potent inhibitor of vascular endothelial growth factor
(VEGF) receptor tyrosine kinases, in women with ovarian cancer will
be presented as a Late Breaking Abstract (abstract LBA5500).

Olaparib has already shown efficacy as a monotherapy and was recently
granted Priority Review by the FDA for the treatment of platinum
sensitive relapsed ovarian cancer patients who have a BRCA mutation.
Additionally, in the Phase III (ICON 6) trial, cediranib demonstrated
significant improvements in progression free survival and overall
survival in platinum sensitive relapsed ovarian cancer, when given
during and after chemotherapy, compared to chemotherapy alone.

During the ASCO conference AstraZeneca will host a briefing for
analysts and investors, to be held in Chicago on 2 June 2014.

KEY ASTRAZENECA ABSTRACTS TO BE FEATURED AT ASCO

* Data included in abstracts is preliminary only and does not
necessarily represent full data sets.

Oral presentations, included in official programme:

· #3001 Lutzky J, et al. A Phase 1 study of MEDI4736, an Anti-PD-L1
Antibody, in Patients With Advanced Solid Tumors. Oral presentation,
09.57am - 10.09am 3 June 2014.

· #3002 Segal NH, et al. Preliminary Data from a Multi-Arm Expansion
Study of MEDI4736, an Anti-PD-L1 Antibody. Oral presentation, 10.09am
- 10.21am 3 June 2014.

· #8009 Janne P, et al. Clinical activity of the mutant selective
EGFR Inhibitor AZD9291 in patients (pts) with EGFR inhibitor
resistant non-small cell lung cancer (NSCLC). Oral presentation
8.00am - 8.12am 31 May 2014.

Late breaking abstract:

· #LBA5500 Liu JF, et al. A randomized phase 2 trial comparing
efficacy of the combination of the PARP inhibitor olaparib and the
anti-angiogenic cediranib against olaparib alone in recurrent
platinum-sensitive ovarian cancer. Oral presentation 1:15 PM - 1:27
PM 31 May 2014.

Other key MEDI4736 abstracts to be featured:

· #TPS3120 ^ Callahan MK, et al. A phase 1 study to evaluate the
safety and tolerability of MEDI4736, an anti-PD-L1 antibody, in
combination with tremelimumab in patients with advanced solid
tumours. General poster session 8:00 AM - 11:45 AM 1 June 2014.

· #TPS9108 Gordon MS, et al. Phase 1 study of MEDI4736, an
anti-PD-L1 antibody, in combination with dabrafenib and trametinib or
trametinib alone in patients with unresectable or metastatic
melanoma. General poster session 8:00 AM - 11:45 AM 31 May 2014.

· #3012 Hyman D, et al. A phase 1 study of MEDI3617, a selective
angiopoietin-2 inhibitor, alone and in combination with
carboplatin/paclitaxel, paclitaxel, or bevacizumab in patients with
advanced solid tumors. General poster session 1:15 PM - 4:15 PM 2
June 2014.

· #8021 Brahmer J, et al. Clinical activity and biomarkers of
MEDI4736, an anti-PD-L1 antibody, in patients with NSCLC. Poster
highlights session 8:00 AM - 11:00 AM 3 June 2014.

· #2602 Fairman D, et al. Pharmacokinetics of MEDI4736, a fully
human anti-PDL1 monoclonal antibody, in patients with advanced solid
tumours. General poster session 8:00 AM - 11:45 AM 1 June 2014.

Other key AZD9291 abstract to be featured:

· #8092 Thress K, et al. EGFR mutation detection in ctDNA isolated
from NSCLC patient plasma; a cross-platform comparison of leading
technologies to support the clinical development of AZD9291. General
poster session 1:15 PM - 5:00 PM 31 May 2014.

Other key olaparib abstracts to be featured:

· #TPS5616 Moore K, et al. SOLO1 and SOLO2: Randomized phase III
trials of olaparib in patients (pts) with ovarian cancer and a
BRCA1/2 mutation (BRCAm). General poster session 8:00 AM - 11:45 AM
31 May 2014.

· #2599 Vergote I, et al. Effect of food on the pharmacokinetics
(PK) of olaparib after oral dosing of the capsule formulation.
General poster session 8:00 AM - 11:45 AM 1 June 2014.

· #5534 Lheureux S, et al. Characterization of ovarian cancer
long-term responders on olaparib. General poster session 8:00 AM -
11:00 AM 2 June 2014.

· #5536 Dougherty B, et al. Analysis of candidate homologous repair
deficiency genes in a clinical trial of olaparib in patients (pts)
with platinum-sensitive, relapsed serous ovarian cancer (PSR SOC).
Poster Highlights session 8:00 AM - 11:00 AM 2 June 2014.

Other abstracts to be featured:

· #11111 Gan H, et al. First-in-human phase I study of a selective
c-Met inhibitor volitinib (HMP504/AZD6094) in patients with advanced
solid tumors General Poster Session 1:15 PM - 5:00 PM...

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