AstraZeneca has new data backing the profile of its chronic obstructive pulmonary disease (COPD) triple therapy Breztri Aerosphere as it waits for approvals in Europe and the US.
The ETHOS trial of Breztri (formerly PT010) showed that the triple therapy achieved a significant reduction in the rate of moderate or severe exacerbations compared with two-drug therapies, backing up the results of the earlier KRONOS trial which was used as a basis for regulatory filings.
AZ is only revealing top-line results from ETHOS at the moment, but Mene Pangalos, head of the company’s biopharma R&D division, said that the two trials show that the drug can “reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous 12 months”.
In KRONOS, there was a 52% reduction in the rate of moderate or severe COPD exacerbations with Breztri compared with AZ’s two-drug Bevespi glycopyrronium/formoterol fumarate, and a 17% reduction versus older drug Symbicort (formoterol fumarate/budesonide).
Breztri – which combines long-acting beta agonist (LABA) formoterol fumarate, long-acting muscarinic antagonist (LAMA) glycopyrronium and inhaled corticosteroid (ICS) budesonide – is playing catch-up in the market with GlaxoSmithKline’s Trelegy, which launched in 2017, and another triple from Chiesi.
Breztri has its first approval in hand – in Japan – but isn’t due for regulatory decisions in Europe and the US until next year. It’s also been filed in China where it has been granted a priority review from the national regulator.
After a slow start, Trelegy (vilanterol/umeclidinium/ fluticasone furoate) is showing signs of gathering momentum, with sales more than doubling to around $250m in the first half of this year.
First to market in Europe was Chiesi with its Trimbow (formoterol fumarate, glycopyrronium and beclomethasone) product, although this has to be administered twice-daily while Trelegy is dosed just once per day. Privately-held company Chiesi doesn’t reveal sales figures for its brands.
The lead investigator in ETHOS, Klaus Rabe of the University of Kiel and Clinic Grosshansdorf in Germany, said a key finding in the trial is that Breztri works with different doses of the ICS drug.
“This is also the first time we have seen the benefit of fixed-dose triple-combination therapy at two ICS doses, which could transform treatment practice by allowing physicians to select the optimal dose for individual patients,” he said.
Steroid drugs are a mainstay of treatment for COPD patients who suffer frequent exacerbations, but are generally used as sparingly as possible as they are linked to potentially serious side effects such as pneumonia.
There is no realistic way to compare Trelegy and Breztri, but AZ has suggested that its product, which is delivered by a metered dose inhaler (MDI), could be preferred by patients over GSK’s dry powder inhaler (DPI) device, particularly for those with restricted lung function.