Phase III SENSCIS trial of Ofev shows efficacy in interstitial lung disease

Boehringer announced that the phase III SENSCIS trial of Ofev (nintedanib) met its primary endpoint: reduction in the annual rate of decline in forced vital capacity (FVCa) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). Results show that nintedanib slows the loss of pulmonary function in patients with SSc-ILD compared to placebo. Patients taking nintedanib showed a 44% reduction in the rate of decline of their lung function, measured in FVC assessed over 52 weeks. Results also showed that nintedanib had a safety and tolerability profile similar to that observed in patients with idiopathic pulmonary fibrosis (IPF), with the most common adverse event being diarrhoea. At the end of the 52-week trial, patients receiving nintedanib had an adjusted annual rate of decline in FVC (mL/year) of -52.4 with nintedanib, versus -93.3 with placebo (absolute difference 41.0mL/year [95% CI 2.9, 79.0]; p=0.04). This corresponds to a relative difference of 44% reduction in lung function decline1, similar to the results from the Phase III INPULSIS trials in IPF.

Nintedanib is already approved in more than 70 countries for the treatment of IPF. These trial results formed the basis of the application for regulatory approval of nintedanib in SSc-ILD that was filed with the FDA and EMA by Boehringer in the first quarter of 2019. The FDA recently granted priority review to the supplemental application for nintedanib in SSc-ILD. The regulatory submissions are part of the company’s ongoing commitment to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need. These new data were published in the New England Journal of Medicine (NEJM) and presented to the medical community at the American Thoracic Society (ATS) International Conference.