ASTRAZENECA UPDATES ON PROGRESS OF ONCOLOGY PIPELINE AT ESMO 2014 CONGRESS

AstraZeneca has presented new data from its pipeline of investigational cancer
medicines at the European Society of Medical Oncology (ESMO) 2014 Congress in
Madrid. Together with MedImmune, its global biologics research and development
arm, the company presented data from over 40 abstracts, building on results
highlighted earlier this year at the American Society for Clinical Oncology
(ASCO) congress.

Highlights include:

  · Preliminary results in the ongoing Phase I MEDI4736 (PD-L1) + tremelimumab
(CTLA-4) combination study in patients with non-small cell lung cancer (NSCLC)
who have already received prior cancer treatments.

  · Updated data from a Phase I monotherapy study of MEDI4736 in patients with
metastatic squamous cell carcinoma of the head and neck (SCCHN).

  · Further data from the Phase I/II study of AZD9291 in patients with epidermal
growth factor receptor mutation positive (EGFRm) T790M+ advanced NSCLC who had
disease progression following treatment with an EGFR tyrosine kinase inhibitor
(TKI).

Briggs Morrison, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca said: "At ASCO we presented data
demonstrating the strength and rapid progression of our oncology pipeline, which
we believe has the potential to redefine the way cancer patients are treated.
The data presented here at the ESMO 2014 Congress further builds our clinical
understanding of the key assets across our core areas of focus: immuno-oncology,
the genetic drivers of cancer and acquired resistance and DNA damage repair. We
are encouraged by the results we are seeing and look forward to providing
further updates as we continue to work at pace to get these potentially life
-changing medicines to patients."

Immuno-oncology

MedImmune presented updates on its novel immunotherapy portfolio at the ESMO
2014 Congress through eight abstracts, which reinforce the clinical activity and
tolerability of MEDI4736 as monotherapy and highlight the potential of the
combination of MEDI4736 and tremelimumab.

Specifically, preliminary data was presented on Saturday, 27 September from the
ongoing Phase I study of MEDI4736 in combination with tremelimumab in NSCLC
patients who have already received prior cancer treatments (Antonia, abstract
#1327P). The data covered anti-tumour activity and the tolerability profile of
the combination.

"We are pleased with the results from MEDI4736 in combination with
tremelimumab," said Edward Bradley, Senior Vice President, R&D and Oncology iMED
Head, MedImmune. "While it is still early with a limited data set, the
tolerability profile is encouraging. We have also seen some evidence of clinical
activity in patients who have failed prior lines of therapy and whose tumour
does not express PD-L1. This supports our strategy to explore this combination
more broadly, particularly in the PD-L1 negative population. This trial will
identify the optimal dose to take into our Phase III clinical programme."

MEDI4736 is an investigational, engineered, human monoclonal antibody directed
against an immune system 'checkpoint', known as programmed cell death ligand 1
(PD-L1). Tremelimumab targets a separate immune checkpoint, CTLA-4. Several
checkpoints such as PD-L1 and CTLA-4, which the body normally uses to dampen the
immune response, can be hijacked by tumour cells to escape detection by the
immune system and facilitate malignant growth. Immunotherapies are designed to
enable the immune system to counteract these tactics employed by cancer cells.
By targeting more than one hijacked checkpoint, combination therapies have the
potential to be more effective than monotherapy in treating this disease.

MedImmune has initiated additional Phase I immunotherapy combination trials,
including MEDI4736 + MEDI0680 (PD-1) and MEDI4736 + MEDI6469 (OX40)*.

Ongoing Phase I data were also presented on Saturday, 27 September, assessing
the clinical activity and safety profile of MEDI4736 as a monotherapy in
patients with NSCLC (Antonia, abstract #1325P). On Sunday, 28 September,
MedImmune presented additional MEDI4736 monotherapy data in a Phase I dose
-expansion study of patients with solid tumours. This data set provided further
information on the clinical activity and tolerability profile of MEDI4736 across
a range of solid tumours, including pancreatic cancer, gastric cancer and
hepatocellular cancer (Segal, abstract #1058PD). A separate analysis of patients
with metastatic SCCHN was also shared (Fury, abstract #988PD). The Phase I data,
coupled with the pre-clinical data, support the accelerated development of
MEDI4736 into Phase III clinical trials in both NSCLC and SCCHN.

Separately, MedImmune has also recently commenced a Phase I human OX40 agonist
(MEDI6383) monotherapy study in cancer patients with recurrent or metastatic
solid tumors.

Small molecules

On Sunday, 28 September, AstraZeneca presented updates on key assets in its
small molecule portfolio, including the investigational NSCLC medicine AZD9291,
a highly selective, irreversible inhibitor of both the activating sensitising
EGFR mutation (EGFRm) and the resistance mutation T790M, IRESSA® (gefitinib) and
the PARP inhibitor olaparib.

Updated data from the ongoing AURA Phase I/II study (Yang, Abstract #449PD)
provided an update on the activity and safety of AZD9291 in patients with EGFRm
T790M+ advanced NSCLC whose disease had progressed following treatment with an
EGFR TKI. This builds on data from the AURA study presented earlier in the year
at ASCO. AstraZeneca has initiated both Phase II and Phase III studies in this
patient population (AURA 2 and AURA 3 respectively).

In addition, a Phase III study evaluating AZD9291 in first line EGFRm advanced
NSCLC is scheduled to start later this year.

AstraZeneca is also currently investigating combinations of AZD9291 with
MEDI4736, and with other investigational drugs selumetinib (small molecule MEK
inhibitor) and AZD6094 (small molecule MET inhibitor) in NSCLC.

Antoine Yver, Head of Oncology, Global Medicines Development, AstraZeneca, said
"The updated data we have presented at the ESMO 2014 Congress reinforce our
strategy of moving rapidly into Phase III development with AZD9291 in EGFRm
T790M+ advanced non-small cell lung cancer. We have already made significant
progress with our accelerated development programme and we anticipate filing for
regulatory approval in the US in the second half of 2015."

AstraZeneca also presented data from the Phase III IMPRESS study for IRESSA, a
second line, combination study in patients with EGFRm advanced NSCLC who have
acquired resistance to first line IRESSA.

Separately, new data was presented on the impact of olaparib on the quality of
life of patients with BRCA mutated platinum-sensitive relapsed ovarian cancer.
The Committee for Medicinal Products for Human Use is expected to provide its
opinion on olaparib in the EU on 23 October 2014, and the US FDA Prescription
Drug User Fee Act date is set for 3 January 2015.

AstraZeneca hosted a briefing for analysts and investors at the ESMO 2014
Congress on the evening of Sunday, 28 September 2014. The presentation from the
event is available at:
astrazeneca.com/investors (http://www.astrazeneca.com/investors).

*MEDI6469 is an in-licensed asset from Agonox.

About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a
global, innovation-driven biopharmaceutical business that focuses on the
discovery, development and commercialization of small molecule and biologic
prescription medicines. MedImmune is pioneering innovative research and
exploring novel pathways across key therapeutic areas, including respiratory,
inflammation and autoimmunity; cardiovascular and metabolic disease; oncology;
neuroscience; and infection and vaccines. The MedImmune headquarters is located
in Gaithersburg, Md., one of AstraZeneca's three global R&D centers. For more
information, please visit www.medimmune.com.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com

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29 September 2014

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