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AZ starts pivotal trials of lung cancer immunotherapy

Moves MEDI4736 into phase III testing for non-small cell lung cancer

AstraZeneca AZAstraZeneca has moved its most-anticipated pipeline candidate MEDI4736 into phase III testing as a treatment for non-small cell lung cancer (NSCLC) and other solid tumours.

MEDI4736 was developed by AZ's Medimmune unit and is an immunotherapy targeting PD-L1, a cell surface receptor that inhibits the activity of T lymphocytes and - when blocked - could restore a patient's own ability to kill tumour cells.

AZ has enormously high hopes for the drug, and said in its recent strategy document designed to discourage - or possible drive up the value of - a threatened takeover by Pfizer that it believes MEDI4736 has the potential to reach peak annual sales of around $6.5bn by 2023.

The first phase III trial of the drug - called PACIFIC - will compare it to placebo on progression-free survival and the overall survival rate in around 700 NSCLC patients previously treated with chemoradiotherapy.

The PACIFIC trial is the first pivotal study of an immunotherapy in this patient population, according to AZ's chief medical officer Briggs Morrison, who noted that lung cancer is still the leading killer in oncology and there is "a clear need for more treatment options to provide patients with a better chance of beating the disease".

According to the latest statistics from the World Health Organization (WHO), lung cancer was responsible for 1.59 million deaths, or one in five of all fatalities from cancer in 2012.

PD-L1 is also targeted by Roche's RG7446 (MPDL3280A), which is already in phase III and expected to be filed for NSCLC in 2016, although AZ believes it has a good chance of being first to market for stage III NSCLC following chemoradiotherapy.

Meanwhile, Merck & Co's MK-3475 - filed for melanoma earlier this year - and Bristol-Myers Squibb's nivolumab for NSCLC are targeting a related receptor called PD1. BMS has said it will shortly start a rolling marketing application for nivolumab in the US.

AZ is due to present phase I and II data on MEDI4736 at the American Society of Clinical Oncology (ASCO) meeting which gets underway on May 30 and also says it will start pivotal trials in a second cancer indication later this year.

Article by
Phil Taylor

9th May 2014

From: Research

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