Date: 2011-09-22
Type of information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in the New England Journal of Medicine
Company: Boehringer Ingelheim (Germany)
Product: BIBF 1120*
Action
mechanism: BIBF 1120* is an investigational small molecule tyrosine kinase inhibitor.
Disease: idiopathic pulmonary fibrosis
Therapeutic area: Lung diseases
Country:
Trial
details: The phase II TOMORROW trial was a 12-month, randomized, double-blind, placebo-controlled trial conducted at 92 sites in 25 countries. The trial evaluated the safety and efficacy of oral BIBF 1120* at four dosage levels in 432 patients diagnosed with IPF, as defined by the American Thoracic Society (ATS) and European Respiratory Society (ERS). The primary endpoint for the TOMORROW trial was annual rate of decline in force vital capacity (FVC). Secondary endpoints included acute exacerbations, quality of life using the St. Georges Respiratory Questionnaire (SGRQ)and total lung capacity. 1,6 In patients treated with 150 mg twice daily BIBF 1120*, FVC declined by 0.06 litres per year as compared with 0.19 litres per year in patients treated with placebo. 1 This dose also resulted in a lower incidence of acute exacerbations versus placebo (2.4 versus 15.7 per 100 patient years; p=0.02). 1 The decrease in quality of life measured by SGRQ was lower with BIBF 1120* than with placebo. The most frequent adverse events were diarrhoea, nausea, and vomiting, which led to more discontinuations in the 150 mg bid group than in placebo (the respective rates were 11.8% vs. 0%, 4.7% vs. 0%, and 2.4% vs. 1.2%); liver transaminase increases were more frequent in the 150 mg twice daily group than placebo.
Latest
news: Boehringer Ingelheim has announced that Phase II clinical trial results, published in the New England Journal of Medicine, for its investigational tyrosine kinase inhibitor (TKI) BIBF 1120* showed a positive trend in reducing lung function decline in patients with idiopathic pulmonary fibrosis (IPF). In the study, known as TOMORROW (To I mprove Pulm ona ry Fib rosis with BIBF 1120), patients treated with 150 mg of BIBF 1120* twice daily demonstrated a 68 percent reduction in the rate of forced vital capacity (FVC - volume of air that is expelled into a spirometer following maximum inhalation) decline compared to placebo (0.06 litres per year in the BIBF 1120* 150 mg bid arm vs. 0.19 litres per year in the placebo arm). In addition, treatment with 150 mg BIBF 1120* twice daily resulted in a small decrease in the SGRQ score (St George’s Respiratory Questionnaire) as compared with an increase in placebo (-0.66 vs. 5.46; p= 0.007). 1,6 SGRQ scores measure the impact of quality of life, with higher scores – as well as increasing scores – signalling greater impairment. The overall incidence of adverse events was comparable in all groups, as was the number of patients with serious or severe adverse events, and adverse events requiring hospitalisation. 1 The proportion of patients with serious adverse events was numerically lower in the 150 mg twice daily dose group (27.1 percent) compared with placebo (30.6 percent). The primary manuscript, the NEJM paper will be presented at the European Respiratory Society (ERS) 2011 Annual Congress on Monday 26 September 2011. Additional results of the TOMORROW trial will be presented during oral sessions at ERS on Sunday 25 September and at a BI-sponsored symposium on Monday 26 September. Two pivotal phase III clinical trials are currently underway enrolling 970 patients in 20 countries. The first patients entered the trials in April and May 2011, respectively.
