- AstraZeneca's lung drug Bevespi Aerosphere failed to beat a rival treatment from GlaxoSmithKine in COPD, as topline results from a Phase 3b study comparing the two fell short of demonstrating the AstraZeneca medicine's superiority.
- The 24-week study of 1,119 patients pitted Bevespi Aerosphere against GSK's Anoro Ellipta for treating moderate to very severe COPD, or chronic obstructive pulmonary disease. AstraZeneca's contender failed to show superiority in peak forced expiratory volume in one second (FEV1) or even non-inferiority on trough FEV1. Bevespi did, however, demonstrate non-inferiority on peak FEV1.
- "The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data," Colin Resiner, AstraZeneca's head of respiratory and global medicines development, said in a statement. "A full analysis is underway to understand and characterise these findings and will be presented at a forthcoming medical meeting."
The results are a blow to AstraZeneca, with Bevespi Aerosphere (glycopyrronium/formoterol fumarate) posting mixed results on peak FEV1 and a miss on trough FEV1 when compared to Anoro Ellipta (umeclidinium/vilanterol).
A year after gaining approval, AstraZeneca launched the Phase 3b AERISTO trial in an attempt to prove its treatment's superiority over the GSK rival. That decision appears to have backfired with these results, as Bevespi failed to show superiority or even consistent non-inferiority versus Anoro Ellipta.
COPD is a huge space within respiratory diseases, globally affecting about 384 million people. Roughly one-third of patients are initially diagnosed with a severe or very severe form.
The sales figures help explain why AstraZeneca would take a risk in doing the study. While Anoro posted $440 million in sales for 2017, the newer and less established Bevespi had just $16 million last year.
Simultaneously, both big pharmas are also advancing triple combinations for COPD, with GSK in the lead once again with its Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder).
Trelegy gained FDA approval in September 2017 as the first once-daily COPD triple combo. AstraZeneca has been working to catch up in that space as well with PT010, its own triple combo inhaler for the chronic lung disease.
In January, the company released topline data showing PT010 beat out three of its own two-in-one drugs in a Phase 3 trial. At the time, AstraZeneca hoped to finish PT010's U.S. and European applications in 2019.
In the broader respiratory space, AstraZeneca posted $2.4 billion in sales for the first half of 2018, flat from the same period last year in constant currencies, while GlaxoSmithKline had sales of roughly $4.2 billion over the same period, a 1% year-over-year decline in constant exchange rates.
AstraZeneca did not offer much details on next steps for Bevespi following this study, only noting that it would analyze the results to present at a future medical conference.