ATS: Amgen, AZ say data backs Tezspire’s role in COPD

Amgen and AstraZeneca have said their severe asthma therapy Tezspire could have a role to play in chronic obstructive pulmonary disease (COPD) – a key target indication for the drug – despite missing its primary objective in a clinical trial.

The phase 2a COURSE study – reported at the American Thoracic Society (ATS) congress – showed that the anti-TSLP-antibody wasn’t able to achieve a statistically significant reduction in the annual rate of moderate to severe COPD exacerbations compared to placebo.

There was a non-significant 17% reduction compared to control after 52 weeks in the patient population, which included a mixed population of COPD patients, including individuals with and without emphysema and chronic bronchitis, a broad range of blood eosinophil counts, and variable smoking status.

Drilling down into the data, however, there was a 37% reduction in exacerbations in a subgroup of patients with a baseline eosinophil count (BEC) 150 cells/μL or more, a population that Amgen and AZ say represents around two-thirds of COPD patients who would be eligible for a biological treatment.

Among patients with even higher BEC levels of 300 cells/μL or more, Tezspire (tezepelumab) also achieved a 46% reduction in moderate or severe exacerbations. Trends towards improved outcomes were also seen with the drug on lung function scores and patient-reported outcomes (PRO) data.

The big question is how the results compare with Sanofi and Regeneron’s IL-4 and IL-13 inhibitor Dupixent (dupilumab), which aced two phase 3 trials in COPD and is currently under review for this indication by the US FDA, with a decision due next month.

In the BOREAS and NOTUS trials, Dupixent cut the rate of exacerbations by 30% and 34%, respectively, and both those studies specifically enrolled patients with BEC levels of 300 cells/μL or above.

On the face of it, the Tezspire data suggest it could offer higher efficacy, although, a truer picture won’t emerge until larger phase 3 trials of the drug are completed.

“Despite advances in treatments for patients with COPD, there is still a pressing need for effective therapies that can improve their clinical outcome, especially for those with eosinophil counts above 150 cells/µL,” said Jay Bradner, Amgen’s head of R&D.

“We are now actively planning a phase 3 clinical programme evaluating tezepelumab in patients with COPD,” he added.

Analysts at Evercore ISI have previously predicted that Dupixent could make $3.5 billion in sales from COPD alone, so Amgen and AZ may now be able both to tap into that sizeable market opportunity and extend the range of COPD patients who could benefit from treatment with a biologic therapy.

First launched in 2021, sales of Tezspire reached $653 million last year in severe asthma, fuelled by the launch of a new self-injector version.

There are other TSLP-targeting drugs in clinical development for COPD, including Uniquity Bio’s solrikitug, which has been cleared by the FDA to start phase 2 trials.

Photo by Brett Jordan on Unsplash