Maybe the best way to look at AstraZeneca R&D now is by dividing the research group into two big buckets: cancer and everything else. That “everything else” group was just hit with a widely expected Phase III failure that the drug giant can ill afford as it struggles to make a convincing case for a desperately needed turnaround.
This time the late-stage failure belongs, once again, to its IL-13 asthma drug tralokinumab. In its first of two Phase III studies, the drug failed to significantly reduce annual exacerbation rates. There is a second Phase III underway that AstraZeneca believes could hold the key to ultimate success, saying that they will combine data from the two in determining its future.
In addition, researchers pointed to a sub-population analysis in which patients with an elevated marker for IL-13 responded better to the drug and they plan to make that a special focus of the second trial.
This drug already failed a Phase IIb trial for asthma, raising questions about why the company would go ahead and continue a major late-stage effort needed to get an OK in asthma. But the researchers at the time said they were encouraged by a subgroup analysis that pointed to success. The company quietly dumped the idiopathic pulmonary fibrosis program, but insisted that there was every reason to believe that tralokinumab would work in asthma. On top of that, Roche’s drug lebrikizumab, also an IL-13, came up with a split decision in its two Phase III studies last year that amounted to a severe setback on that front.
AstraZeneca posted some mixed — though generally positive — data from two big Phase III studies of benralizumab, its IL-5 contender in the highly competitive market for severe asthma, last fall. A high placebo response seriously eroded one set of late-stage data.
The pharma giant sold off the dermatology rights for tralokinumab to Leo Pharma, which says it gathered positive IPF data on the drug recently. AstraZeneca also punted rights to brodalumab after that drug proved disappointing, though approvable, in Phase III with evidence that it triggered suicidal thinking.
AstraZeneca’s stock was largely unaffected by the Phase III failure today, which couldn’t have surprised many analysts. The big play at AstraZeneca now is focused on MYSTIC, its combination study of durvalumab and tremelimumab in lung cancer. AstraZeneca has had some big successes in cancer over the last couple of years, winning a first OK for durvalumab and progressing with other drugs like Tagrisso and Lynparza. But outside cancer the company has had a series of grim flops that continue to raise questions about CEO Pascal Soriot’s promise of a turnaround.
Research chief Sean Bohen had this to say in the company’s defense today:
Severe asthma is a heterogeneous disease with significant unmet needs and we will now await the STRATOS 2 results in the second half of 2017 to explore the potential to treat a sub-group of uncontrolled asthma patients with tralokinumab.
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