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AstraZeneca: AstraZeneca and Roche announce partnership to develop companion diagnostic test for AZD9291

AstraZeneca today announced it has entered into collaboration with
Roche to develop a plasma-based companion diagnostic test to support
AZD9291, AstraZeneca's investigational compound in clinical
development for non-small-cell lung cancer (NSCLC).

The companion diagnostic test is designed to identify epidermal growth
factor receptor (EGFR) mutations in both tumour tissue and plasma
derived from patients with NSCLC, and to optimise the clinical
development of AZD9291 for patients who are resistant to
first-generation EGFR tyrosine kinase inhibitors (TKI).

Currently, patients who have been treated with EGFR-TKIs in whom the
disease has progressed have to undergo a repeat biopsy to assess
whether they have a specific mutation, T790M. Diagnostic tests based
on circulating DNA (ctDNA) in plasma samples provide an alternative
method of identifying the T790M mutation.

Mondher Mahjoubi, Senior Vice President, Global Product Strategy for
Oncology at AstraZeneca said: "We are committed to developing
targeted medicines that improve health outcomes for patients.
Understanding the nature of each individual's tumour and therefore
which medicine is most likely to benefit them is vital if we are to
transform the way cancer patients are diagnosed and treated."

"Currently, late-stage lung cancer patients have to undergo surgery to
collect tissue from a tumor so it can be sent for molecular testing,"
said Paul Brown, Head of Roche Molecular Diagnostics (RMD). "In some
cases, collecting enough tissue for testing is not possible. This
collaboration will enable molecular testing through plasma specimens
and provide the information needed to inform treatment decisions
without the complications of surgery, consequently increasing the
level of care clinicians can give to the patient."

NSCLC represents approximately 80 to 85 per cent of all lung cancers.
Unfortunately, at the time of diagnosis approximately 70 per cent of
NSCLC patients have developed advanced or metastatic disease not
amenable to surgical resection.


About AZD9291

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. Patients with EGFRm+ NSCLC are particularly sensitive to
treatment with currently available EGFR TKIs, which block the cell
signalling pathways that drive the growth of tumour cells. However,
tumour cells almost always develop resistance to treatment, leading
to disease progression. In approximately half of patients, this
resistance is caused by the secondary mutation known as T790M. There
are currently no targeted therapies approved for the treatment of
tumours with this resistance mutation.

In the ongoing Phase I study, AZD9291 has shown early evidence of
activity as a once-daily monotherapy with clinical responses observed
in an EGFRm+ population of patients with NSCLC who have previously
failed on EGFR TKIs and also in patients with the T790M mutation. To
date, AZD9291 has been well-tolerated with low rates of side effects.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in
pharmaceuticals and diagnostics. Roche is the world's largest biotech
company, with truly differentiated medicines in oncology, immunology,
infectious diseases, ophthalmology and neuroscience. Roche is also
the world leader in in vitro diagnostics and tissue-based cancer
diagnostics, and a frontrunner in diabetes management. Roche's
personalised healthcare strategy aims at providing medicines and
diagnostics that enable tangible improvements in the health, quality
of life and survival of patients. Founded in 1896, Roche has been
making important contributions to global health for more than a
century. Twenty-four medicines developed by Roche are included in the
World Health Organisation Model Lists of Essential Medicines, among
them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide,
invested 8.7 billion Swiss francs in R&D and posted sales of 46.8
billion Swiss francs. Genentech, in the United States, is a wholly
owned member of the Roche Group. Roche is the majority shareholder in
Chugai Pharmaceutical, Japan. For more information, please visit

All trademarks used or mentioned in this release are protected by law.

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:


AstraZeneca Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 (UK/Global)

Ayesha Bharmal +44 20 7604 8034 (UK/Global)

Vanessa Rhodes +44 20 7604 8037 (UK/Global)

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Roche Media Enquires

Bob Purcell +1 925 730 8114 (US)

AstraZeneca Investor Enquiries

Karl Hård +44 20 7604 8123  mob: +44 7789 654364

Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729

Anthony Brown +44 20 7604 8067 mob: +44 7585 404943

Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627


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