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AZ halts durvalumab combination trials on safety grounds

Saysmove is a precautionary step after respiratory disease reports

AstraZeneca AZ

AstraZeneca (AZ) has suspended two trials involving its PD-1 inhibitor durvalumab (MEDI4736) after reports of respiratory disease in some patients.

The company says the suspension is a precaution and involves studies looking at the combination of durvalumab with its AZD9291 candidate - an orally-active epidermal growth factor receptor (EGFR) inhibitor - in patients with advanced non-small cell lung cancer (NSCLC).

The phase III CAURAL and phase I TATTON trial revealed an increased incidence of interstitial lung disease (ILD) in patients taking the two drugs in tandem. 

CAURAL is being conducted in second-line metastatic EGFR T790M-mutation positive NSCLC patients and is testing AZD9291 plus durvalumab versus AZD9291 monotherapy for their impact on progression-free survival (PFS).

ILD is a broad category of respiratory conditions that is a recognised side effect of some drugs and is characterised by inflammation and scar tissue formation in the tissues surrounding the alveoli (air sacs) in the lungs.

Details are sketchy at the moment, but AZ has said it will offer patents in the studies new consent forms so they can make a decision on whether to continue.

While the implications of the news are hard to gauge, it is notable that the two drugs involved are both fundamental to the fortunes of AZ's oncology portfolio, which has been described as a key growth platform for the company in the coming years.

AZD9291 is a follow-up to Iressa (gefitinib) - which pulled in $273m in sales in the first half of the year - and has been tipped as a potential $3bn-a-year blockbuster thanks to its improved profile versus its parent. 

It was submitted for approval in the US and EU earlier this year for the second-line treatment of patients with advanced or metastatic T790M-mutated NSCLC, and has a breakthrough designation from the FDA for that indication.

Meanwhile, durvalumab is the flagship drug in AZ's immuno-oncology programme, leading the charge as it tries to catch up with the leaders in the checkpoint inhibitor category - Bristol-Myers Squibb (BMS) and Merck & Co. AZ has predicted this could become a $6.5bn product at peak.

Article by
Phil Taylor

12th October 2015

From: Research

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