Double disappointment for AstraZeneca lung drug tralokinumab

AstraZeneca Macclesfield site
This comes after the drug failed its first pivotal test in May.

After a failed trial in May, AstraZeneca hoped tralokinumab could pass subpopulation tests and make it to the finish line, but it wasn’t meant to be.

In a brief update posted this morning, AstraZeneca and its biologics arm MedImmune said that their investigational anti-interleukin-13 (IL-13) mAb flopped in two late-stage tests: STRATOS 2 and TROPOS.

In the former, tralokinumab did not hit a statistically significant reduction in the annual asthma exacerbation rate, the test’s primary endpoint, in patients with severe, uncontrolled asthma (and with high levels of a biomarker, fractional exhaled nitric oxide), when compared to a dummy treatment.

And it was the same story for TROPOS, where AstraZeneca was hoping it could lessen the need for oral corticosteroid, the primary endpoint of the trial, but it failed here, too.

This is a double whammy for the British-headquartered Big Pharma, as it also failed in the STRATOS 1 phase 3 trial, which in May showed it failed to beat out placebo in the annual asthma exacerbation rate.

Both STRATOS tests were pivotal trials, and both failed. STRATOS 2 was also designed as a reprieve from the failed STRATOS 1, as it was looking into a subgroup of patients who were supposed to respond better to the drug. It’s unclear what the future holds for the medication, but last year the company decided to get rid of its program for testing tralokinumab in idiopathic pulmonary fibrosis.

Sean Bohen, EVP of global medicines development and CMO, said simply, “The results are disappointing as we had hoped that tralokinumab would benefit patients with severe asthma, which is a complex disease with limited treatment options today.”

Back when AstraZeneca decided to move the antibody into phase 3 in 2014, CEO Pascal Soriot said the plan for the respiratory disease pipeline was to target subpopulations of patients who responded best to different mechanisms such as those featuring IL-5 and IL-13. And in 2015 it teamed up with Abbott to develop a companion diagnostic to spot patients with biomarkers predictive of upregulated IL-13.

AstraZeneca had been hoping this more targeted approach could enable it to break the run of late-phase misfires for IL-13 drugs.

Roche discontinued development of its IL-13 drug lebrikizumab in asthma after two identical phase 3 trials yielded different results. In one trial the drug succeeded in cutting the rate of severe exacerbations. In the other study it failed against the same endpoint. After sifting through the mixed bag of data, Roche terminated another study in patients with severe corticosteroid-dependent asthma.

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This comes a day after some better news for the company: the FDA approved its new blood cancer drug Calquence (acalabrutinib), which it gained from its buy with Acerta.