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2017-08-31

AstraZeneca: AstraZeneca highlights latest advances in lung cancer at the ESMO 2017 Congress

More than 40 presentations, including data from two pivotal trials
selected as late-breaking abstracts for oral presentation in the ESMO
Presidential Symposia

Phase III PACIFIC data reinforce potential of Imfinzi following US FDA
breakthrough therapy designation in locally-advanced (Stage III)
unresectable NSCLC

Phase III FLAURA results highlight superiority of Tagrisso over
standard of care in previously-untreated patients with advanced EGFRm
NSCLC

At the European Society of Medical Oncology (ESMO) 2017 Congress in
Madrid, Spain, 8-12 September, AstraZeneca and MedImmune, its global
biologics research and development arm, will report results of more
than 40 presentations, including two pivotal clinical trial readouts
selected for late-breaking abstract presentation at the ESMO
Presidential Symposia on Saturday, 9 September, which demonstrate
significant improvements over current standard-of-care treatments in
lung cancer:

· Results from the pivotal Phase III PACIFIC trial showing
statistically-significant and clinically-meaningful progression-free
survival (PFS) benefit with Imfinzi (durvalumab) in patients with
locally-advanced (Stage III), unresectable non-small cell lung cancer
(NSCLC) following standard chemoradiation therapy, a clinical setting
where there are currently no approved treatments.

· Results of the Phase III FLAURA trial showing
statistically-significant and clinically-meaningful PFS with Tagrisso
(osimertinib) over current standard-of-care erlotinib or gefitinib as
1st-line treatments in previously-untreated patients with
locally-advanced or metastatic epidermal growth factor receptor
mutation-positive (EGFRm) NSCLC.

Jamie Freedman, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "The superiority of 1st-line
treatment with Tagrisso in the FLAURA trial and the potentially
transformative Imfinzi data from the PACIFIC trial reinforce our
significant contribution to advancing medicines for patients across
multiple stages of lung cancer. We are also proud to share with the
medical community our progress towards addressing the needs of
patients with other types of difficult-to-treat tumours, including
advanced ovarian, breast, and head and neck cancers."

Pushing the boundaries of lung cancer research

In addition to the two Presidential Symposia presentations, data being
presented at ESMO demonstrate the breadth and depth of AstraZeneca's
commitment to advancing the treatment of lung cancer:

· Overall survival data on Tagrisso from the Phase II AURA trials in
patients with EGFR T790M mutation-positive advanced NSCLC (Abstract
#1348P)

· PFS data and central nervous system (CNS) responses to Tagrisso in
patients with EGFR T790M NSCLC in the Asia Pacific region (AURA17)
(Abstracts #1331P, 1353P and 1354P)

Established expertise in women's cancers

Emerging data from studies of Lynparza, Faslodex, potential new
medicines and combinations within women's cancers will include:

· Latest Phase III OlympiAD efficacy and health-related
quality-of-life data for Lynparza vs. chemotherapy in patients with
HER2-negative metastatic breast cancer and a germline BRCA mutation
(Abstract #243PD and 290P)

· Phase III SOLO-2 data for Lynparza maintenance therapy in patients
with platinum-sensitive relapsed ovarian cancer (Abstract #932PD)

Sustained commitment in head and neck cancer

AstraZeneca is presenting additional evidence of the efficacy and
safety of Imfinzi and the early potential of its combination strategy
in head and neck cancer, including oral presentations on:

· Preliminary data from the Phase II HAWK study of Imfinzi in
recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
(Abstract #10420)

· Safety, tolerability and anti-tumour activity in the Phase Ib/II
SCORES study of Imfinzi in combination with STAT3 inhibitor AZD9150
or CXCR2 inhibitor AZD5069, in patients with HNSCC (Abstract #1049PD)

- ENDS -

NOTES TO EDITORS

AstraZeneca/MedImmune key presentations at the ESMO 2017 Congress

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|Lead |Abstract|Presentation details |
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+------+--------+-----------------------------------------------+

Lung cancer

+----------+---------------------+---------------------------------------------+
|Paz-Ares L|PACIFIC: A double |OralLung CancerSaturday 9th September, 16:30 |
| |-blind, placebo |-18:10 |
| |-controlled Phase III|Presentation Time: 16:30-16:45 Location: |
| |study of durvalumab |Madrid AuditoriumAbstract #LBA1 |
| |after | |
| |chemoradiationtherapy| |
| |(CRT) in patients | |
| |with Stage III, | |
| |locally advanced, | |
| |unresectable NSCLC | |
+----------+---------------------+---------------------------------------------+
|Ramalingam|Osimertinib vs SoC |OralLung CancerSaturday 9th September, 16:30 |
|S |EGFR-TKI as first |-18:10 |
| |-line treatment in |Presentation Time: 17:30-17:45 Location: |
| |patients with EGFRm |Madrid AuditoriumAbstract #LBA2 |
| |advanced NSCLC | |
| |(FLAURA) | |
+----------+---------------------+---------------------------------------------+
|Zhou C |Detection of EGFR |PosterLung CancerSaturday 9th September, |
| |T790M in Asia-Pacific|13:15-14:15 Location: Hall 8Abstract #1331P |
| |patients (pts) with | |
| |EGFR mutation | |
| |-positive advanced | |
| |non-small cell lung | |
| |cancer (NSCLC): | |
| |circulating tumour | |
| |(ct) DNA analysis | |
| |across 3 platforms | |
+----------+---------------------+---------------------------------------------+
|Zhou C |Osimertinib in Asia |PosterLung CancerSaturday 9th September, |
| |-Pacific patients |13:15-14:15 Location: Hall 8Abstract #135P |
| |(pts) with EGFR T790M| |
| |-positive advanced | |
| |NSCLC: updated Phase | |
| |II study results | |
| |including progression| |
| |-free survival (PFS) | |
+----------+---------------------+---------------------------------------------+
|Zhou C |CNS response to |Poster Lung CancerSaturday 9th September, |
| |osimertinib in Asian |13:15-14:15 Location: Hall 8Abstract #1353P |
| |-Pacific patients | |
| |(pts) with T790M | |
| |-positive advanced | |
| |NSCLC: data from an | |
| |open-label Phase II | |
| |trial (AURA17) | |
+----------+---------------------+---------------------------------------------+
|Mitsudomi |Overall survival (OS)|PosterLung CancerSaturday 9th September, |
|T |in patients (pts) |13:15-14:15 Location: Hall 8Abstract #1348P |
| |with EGFR T790M | |
| |-positive advanced | |
| |non-small cell lung | |
| |cancer (NSCLC) | |
| |treated with | |
| |osimertinib: results | |
| |from two Phase II | |
| |studies | |
+----------+---------------------+---------------------------------------------+
|Pinotti G |EGFR T790M detection |PosterLung CancerSaturday 9th September, |
| |in TKI-naïve NSCLCs |13:15-14:15Location: Hall 8Abstract #1335P |
| |carrying sensitive | |
| |EGFR mutations ...

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