AstraZeneca Breztri Reports Positive Phase III Trial Results

Results from the Phase III KALOS and LOGOS trials evaluating AstraZeneca Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) in patients with uncontrolled asthma have been published in The Lancet Respiratory Medicine, reporting statistically significant and clinically meaningful improvements compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) therapies.

The studies compared Breztri with Symbicort (budesonide/formoterol fumarate or BFF, a standard therapeutic option), PT009 (BFF in an Aerosphere formulation), and the Symbicort and PT009 treatment groups combined.1 Breztri is delivered as a single-inhaler, fixed-dose triple-combination of ICS/LABA and a long-acting muscarinic antagonist (LAMA).

In a pre-specified pooled analysis of the primary endpoints across both trials, AstraZeneca Breztri demonstrated superior lung function outcomes over 24 weeks versus dual therapy (the ICS/LABA treatment groups combined). Improvements included a 76mL increase (95% CI 57-94 mL, unadjusted p<0.001, as measured by morning pre-dose trough FEV1 over 24 weeks) and a 90mL increase (95% CI 72-108 mL, unadjusted p<0.001, as measured by FEV1 AUC0-3 over 24 weeks).1

The pooled data further showed clinically meaningful reductions in the annualised rate of severe asthma exacerbations compared with ICS/LABA medicines. These reductions were observed in patients regardless of whether they had experienced a recent asthma exacerbation. Full findings are detailed in The Lancet Respiratory Medicine.

Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: “Many of the 262 million people worldwide living with asthma remain uncontrolled and still struggle with symptoms like frequent breathlessness, coughing and wheezing despite the use of dual maintenance therapy. The KALOS and LOGOS trials show that the single fixed-dose triple therapy budesonide/glycopyrronium/formoterol, which combines the efficacy of an ICS, LAMA, and LABA, improved lung function, and, importantly, prevented future severe exacerbations in patients, regardless of exacerbation history.”

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “With so many patients still experiencing the debilitating effects of uncontrolled asthma, we are excited about the potential for Breztri to improve lung function as well as prevent exacerbations in asthma. Building on its well-established profile in COPD, we hope to bring Breztri to patients with uncontrolled asthma as quickly as possible.”

No new safety or tolerability signals were identified for Breztri in either the KALOS or LOGOS trials.

Breztri is approved as an inhaled triple-combination therapy for the treatment of chronic obstructive pulmonary disease (COPD) in adults in more than 80 countries worldwide, including the US, EU, China and Japan. Regulatory filings for Breztri in asthma are currently under review in all major regions.