New analyses of phase III data for Ofev (nintedanib) shows reduction in progression of idiopathic pulmonary fibrosis- Boehringer

A new analyses from the pooled Phase III INPULSIS trials of Ofev (nintedanib), from Boehringer, in idiopathic pulmonary fibrosis showed that OFEV significantly reduced the risk of disease progression by 40% (27.1%, OFEV vs. 41.4%, placebo), as measured by a composite endpoint of worsening in lung function (absolute decline in FVC more than 10%) or death over 52 weeks. Furthermore, the analyses showed there was a consistent reduction in disease progression across a range of patients defined by baseline FVC. In addition, OFEV's clinical benefit was consistent across subgroups. OFEV slowed the decline in lung function regardless of the patient's GAP stage (gender, age and disease physiology) at baseline.

OFEV also significantly reduced the risk for time to first acute exacerbations reported by investigators as serious adverse events by 43% (3.6%, OFEV vs. 6.1%, placebo) and 70% (1.6%, OFEV vs. 5%, placebo) for serious adverse events adjudicated as confirmed or suspected acute exacerbations. Acute exacerbations reported as serious adverse events were associated with a higher risk of death than acute exacerbations reported as non-serious adverse events. Finally, one-year data on adverse events collected from more than 6,700 U.S. OFEV patients from post-marketing surveillance, including real-world clinical data, was consistent with those seen in the pivotal clinical trials. No new safety concerns or unexpected safety signals were observed.

Comment: Pirfenidone (Esbriet) from Intermune/Roche is a competitor to nintedanib and both Esbriet and Ofev are US and EU approved to treat Idiopathic Pulmonary Fibrosis.