Efficacy: other exploratory analyses in PPF
PROGRESSION-FREE SURVIVAL
In a prespecified exploratory analysis, JASCAYD® demonstrated a nominal improvement in progression-free survival1
Progression-free survival is defined as patients who had ≤10% absolute decline in FVC percent predicted from baseline and survived over the duration of the trial.1
The key secondary endpoint (time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death over duration of trial) was not met. The analyses of the secondary and further endpoints of time to death and time to progression were not part of confirmatory testing and are exploratory in nature.2
PROGRESSION-FREE SURVIVAL OVER THE DURATION OF THE TRIAL (UP TO 114 WEEKS)1
Limitations: Results from the blinded trial analysis (up to 109 weeks) and end of trial analysis (up to 114 weeks) are explorative in nature and for descriptive purposes only.
According to the ATS/ERS/JRS/ALAT Guideline, >10% decline in FVC is an established marker of disease progression and a surrogate marker for mortality. The hazard ratio for progression-free survival, assessed until the end of trial (up to 114 weeks), did not show a significant treatment difference for JASCAYD® compared to placebo (HR: 0.71 [0.56, 0.89]).1,3
Quicklinks
References
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Data on file. Boehringer Ingelheim International GmbH. FIBRONEER-ILD CTR. 2025.
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Maher TM, Assassi S, Azuma A, et al. FIBRONEER™-ILD Trial Investigators. Nerandomilast in patients with progressive pulmonary fibrosis. N Engl J Med. 2025;392(22):2203–2214.
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Raghu G, Collard HR, Egan JJ, et al. ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. Idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011;183(6):788-824.
MLR ID: PC-AE-102895
Expiry Date: 10/05/2028