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
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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:


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