New sub-analyses show that brensocatib reduced pulmonary exacerbations and slowed lung function decline for most subgroups of patients with non-cystic fibrosis bronchiectasis.
RT’s Three Key Takeaways:
- Brensocatib Reduces Pulmonary Exacerbations: Subgroup data from the phase 3 ASPEN study showed that brensocatib lowered the annualized rate of pulmonary exacerbations compared to placebo across most patient subgroups.
- Slows Lung Function Decline: Brensocatib 25 mg consistently demonstrated a reduced decline in lung function, as measured by post-bronchodilator FEV1, in all prespecified subgroups.
- Consistent Efficacy Across Subgroups: The positive effects of brensocatib in reducing exacerbations and slowing lung decline were consistent with results seen in the overall ASPEN population, highlighting its potential for a broad range of bronchiectasis patients.
Biopharmaceutical company Insmed Inc presented positive late-breaking subgroup data from the phase 3 ASPEN study assessing the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis at CHEST 2024.
Consistent with positive results for the overall ASPEN population, the annualized rate of pulmonary exacerbations favored brensocatib at both the 10 mg and 25 mg doses over placebo for almost all subgroups.
In a separate analysis, least squares mean difference for brensocatib 25 mg demonstrated a reduced decline in post-bronchodilator FEV1 at week 52 versus placebo for all prespecified subgroups. Results for patients treated with brensocatib 10 mg among subgroups were aligned with the overall trial population results.
“Given the heterogeneity of this disease, it is striking that these new sub-analyses show a consistent positive impact on the rate of exacerbations across the majority of prespecified subgroups. It is particularly exciting to see that, consistent with the overall trial analysis, brensocatib 25 mg was able to slow lung function decline as measured by FEV1 for all prespecified subgroups, further underscoring the potential impact this investigational treatment candidate may have on a diverse range of patients if approved,” says lead study investigator James Chalmers, MBChB, PhD, professor and consultant respiratory physician at the School of Medicine, University of Dundee, UK, in a release.
Safety of Brensocatib for Bronchiectasis and Next Steps
Brensocatib was well-tolerated in the study. Treatment-emergent adverse events (TEAEs) occurring in at least 5% of patients treated with either dose of brensocatib and more frequently than in placebo were COVID-19 (15.8%, 20.9%, 15.8%), nasopharyngitis (7.7%, 6.3%, 7.6%), cough (7.0%, 6.1%, 6.4%), and headache (6.7%, 8.5%, and 6.9%) for brensocatib 10 mg, brensocatib 25 mg, and placebo, respectively.
“We are incredibly excited to present subgroup findings from the ASPEN study at CHEST 2024, building on the positive results we have already shared with the bronchiectasis community,” says Martina Flammer, MD, MBA, chief medical officer of Insmed, in a release. “The consistency of efficacy observed across most subgroups, particularly at the higher dose, further supports our belief that brensocatib has the potential to transform the treatment landscape for patients with bronchiectasis. We eagerly look forward to filing a new drug application for brensocatib in the U.S., followed by Europe and Japan, in hopes of delivering the first approved therapy for patients affected by this serious and difficult-to-treat disease.”
Insmed plans to file a New Drug Application with the US Food and Drug Administration for brensocatib in patients with bronchiectasis in the fourth quarter of 2024. Pending regulatory approvals, Insmed anticipates a US launch for brensocatib in mid-2025 followed by launches in Europe and Japan in the first half of 2026.
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