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AZ signs two companion diagnostic deals

Will help identify patients suitable for treatment with lung cancer drugs
AstraZeneca AZ headquarters London UK

AstraZeneca has signed a brace of deals for new diagnostics that will help identify patients suitable for treatment with its lung cancer therapies Iressa and AZD9291.

New cancer drugs are increasingly targeted to patients with a specific genetic mutation, so it is important to have supporting diagnostics to make sure only those who will benefit receive new therapies. It is also desirable for those tests to be simple and quick to carry out.

AZ has joined forces with Qiagen to develop a blood test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with epidermal growth factor receptor (EGFR) inhibitor Iressa (gefitinib).

At the moment, patients with NSCLC undergo a tumour biopsy using a needle, or samples of the tumour are taken during surgery.  A simple blood test or 'liquid biopsy' would make it much easier to identify patients who may benefit from Iressa, according to Mondher Mahjoubi, AZ's senior vice president, global product strategy for oncology.

"The use of circulating tumour DNA (ctDNA) testing will allow doctors to target the individual needs of each patient quickly and accurately," he said.

Iressa has become an important product in AZ's pipeline, with sales rising 11 per cent to reach a little under $650m last year, but has started to show signs of slowing down, particularly in Europe.

A blood test could encourage more patients to be started on treatment with the drug, and could also overcome certain limitations of biopsies. For example, in some cases biopsies do not provide enough tissue for testing.

Meanwhile, AZ is also starting the development of a companion diagnostic for its Iressa follow-up AZD9291, which is in early stage clinical studies in NSCLC. In this case the company has enlisted the aid of Roche to develop a test for a specific EGFR mutation in both tissue samples and blood.

AZD9291 is being developed as second-line treatment for NSCLC in patients who have failed treatment with other EGFR-targeting therapies, including Iressa but also rival drugs such as Roche/Astellas' Tarceva (erlotinib).

The drug has been designed to knock out not only the primary EGFR mutation in NSCLC, but also a secondary mutation called T790M that confers resistance to first-line EGFR inhibitors.

Currently, patients who have been treated with EGFR-TKIs in whom the disease has progressed have to undergo a repeat biopsy to see if they have the T790M mutation, so once again a blood test will help doctors make treatment decisions for patients more quickly.

"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," said Paul Brown, head of Roche Molecular Diagnostics .

The diagnostic will also be used to help guide the clinical development of AZD9291, said AZ.


28th July 2014

From: Research, Sales



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