Breztri for asthma meets primary endpoints in two phase 3 trials

Key takeaways:

• The replicate, multicenter, randomized, double-blind, double-dummy, parallel group KALOS and LOGOS phase 3 trials achieved their primary endpoints.
• AstraZeneca will present full data at an upcoming meeting.

Breztri Aerosphere, a triple inhaled therapy, met its primary endpoint of lung function improvement in adults and adolescents with uncontrolled asthma in two phase 3 trials, according to a press release from AstraZeneca.

The metered-dose inhaler combines 320 μg budesonide, an inhaled corticosteroid; 28.8 μg or 14.4 μg glycopyrrolate, a long-acting muscarinic antagonist; and 9.6 μg formoterol fumarate, a long-acting beta2-agonist, according to the release.

“Asthma continues to be one of the most common chronic diseases, affecting more than 260 million patients worldwide,” Caterina Brindicci, PhD, senior vice president and global head of research and development, respiratory and immunology, at AstraZeneca, told Healio.

“In some markets, it is estimated that nearly half of those treated with dual therapy remain uncontrolled, which can significantly limit lung function and decrease quality of life given inflammation and muscle tightening in the airway (bronchoconstriction) can make it difficult to breathe,” Brindicci said.

In the replicate confirmatory, multicenter, randomized, double-blind, double-dummy, parallel group KALOS and LOGOS phase 3 trials, researchers analyzed an approximate 4,400 adults and adolescents (around 2,200 in each trial) with uncontrolled asthma to determine how treatment with Breztri Aerosphere (AstraZeneca) impacts two measures of FEV₁: FEV₁ area under the curve 0 to 3 hours at week 24 and trough FEV₁ over 12 to 24 weeks and over 24 weeks.

As Healio previously reported, the FDA approved Breztri Aerosphere for maintenance treatment of patients with COPD in 2020.

“Breztri forms the backbone of our inhaled medicine portfolio in COPD,” Brindicci told Healio. “The medicine remains the fastest growing triple therapy, beating expectations since its relatively recent launch in COPD and is on track to become a multi blockbuster brand for AstraZeneca in spite of not having the asthma indication as other triple therapies already do.

“A potential indication in asthma would further support this growth,” she said.

Notably, the KALOS and LOGOS trials include two comparator groups. According to the release, one is a combination of 320 μg budesonide and 9.6 μg formoterol fumarate delivered in an Aerosphere metered-dose inhaler (PT009), and the other is a combination of 320 μg budesonide and 9 μg formoterol fumarate delivered in a pressurized metered-dose inhaler (Symbicort, AstraZeneca).

In addition to lung function, researchers are also examining the rate of severe asthma exacerbations up to 52 weeks (primary endpoint) and the percentage of responders in several individual questionnaires at week 24, according to ClinicalTrials.gov. Questionnaires include Asthma Control Questionnaire-7 and -5; Asthma Quality of Life Questionnaire for 12 years and older; and St. George’s Respiratory Questionnaire.

AstraZeneca did not share data from the trials in the release but noted that the inhaler “met all primary endpoints.”

“Results from the phase 3 KALOS and LOGOS trials demonstrate that Breztri has the potential to more effectively manage asthma and evolve the standard of care in a single inhaled triple therapy compared with dual maintenance therapy,” Brindicci told Healio.

“These positive results … highlight the potential for Breztri to serve as a new, more effective option for the many asthma patients who remain uncontrolled on available dual therapies,” she added.

Brindicci told Healio AstraZeneca will share full results with regulatory authorities and present these data at an upcoming medical meeting.

“With the data from the phase 3 KALOS and LOGOS trials, we are confident in the potential of Breztri in asthma and are focused on unlocking its full potential in this indication to drive improvements for patients,” Brindicci said.

“We look forward to building on Breztri’s well-established profile in COPD with these exciting results,” she added.

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Caterina Brindicci, PhD, can be reached at pulmonology@healio.com.