Please login to the form below

Not currently logged in
Email:
Password:

AZ's tremelimumab fails mesothelioma trial

FDA-designated breakthrough therapy did not demonstrate increase in overall survival
AstraZeneca

AstraZeneca's immuno-oncology ambitions have hit a hurdle after its tremelimumab candidate failed to show activity in a trial involving patients with a rare form of cancer.

The CTLA-4 inhibitor failed to show activity against mesothelioma - a form of cancer affecting the lungs or abdomen linked to exposure to hazardous materials such as asbestos - in a phase IIb trial involving 571 patients.

The disappointment comes just weeks after AZ reported that tremelimumab given alongside PD-L1 inhibitor durvalumab achieved impressive results in a non-small cell lung cancer (NSCLC) trial, and the company was quick to stress that the drug "remains a key component of immuno-oncology combination strategy".

Nevertheless, the disappointing results in a trial that had been predicted to support registration of the drug is a setback for AZ as it tries to close the gap behind the leaders in the immuno-oncology category, Bristol-Myers Squibb (BMS) and Merck & Co.

Durvalumab also hit a couple of hurdles last year, including a failed study as a monotherapy in NSCLC and the suspension of two trials in combination with AZ's recently approved Tagrisso (osimertinib) on safety concerns.

Tremelimumab was being tested as a 10mg/kg monotherapy in the DETERMINE study, which involved mesothelioma patients who had already been treated with other drugs and were not candidates for surgery.

The company did not provide any data from the trial, just noting that its drug did not have a significant impact on overall survival, the primary outcome measure. The FDA had previously awarded breakthrough status to tremelimumab as a mesothelioma therapy, recognising that there are few effective treatment options for this aggressive form of cancer.

Tremelimumab works in a similar way to BMS' already-approved Yervoy (ipilimumab) drug, which is used alongside the company's PD-1 inhibitor Opdivo (nivolumab) as a treatment for melanoma.  Yervoy brought in $1.13bn in sales last year while Opdivo added $942m to BMS' top-line.

"We are disappointed that tremelimumab monotherapy did not demonstrate a survival benefit in this patient population with no approved medicines beyond first-line treatment", AZ's head of immuno-oncology Robert Iannone.

"However, we remain confident in tremelimumab's clinical activity in combination", he added.

Article by
Phil Taylor

1st March 2016

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
emotive.

emotive. is an award-winning healthcare communications agency working with leading global and EMEA companies in life sciences including medical device...

Latest intelligence

patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe’s leading hub for life sciences innovation...

Infographics