OFEV ® (nintedanib) TOMORROW trial results Last updated These slides are provided by Boehringer Ingelheim for medical to medical education only.

TOMORROW period 1: Randomised, placebo-controlled, 52-week, dose-finding trial Richeldi L, et al. N Engl J Med 2011;365:1079–1087.

TOMORROW: Endpoints Primary endpoint: Annual rate of decline in FVC Secondary endpoints: Change from baseline to week 52 in SGRQ score Incidence of investigator-reported acute exacerbations of IPF Time to first investigator-reported acute exacerbation of IPF Survival (all cause, respiratory cause) Safety and tolerability FVC, forced vital capacity; SGRQ, St George’s Respiratory Questionnaire. Richeldi L, et al. N Engl J Med 2011;365:1079–1087.

TOMORROW: Inclusion and exclusion criteria Main inclusion criteria: ≥40 years Definite or probable IPF diagnosed according to ATS/ERS criteria 2 <5 years prior to screening, and confirmed by central review of HRCT performed <12 months prior to randomization (mandatory) and surgical lung biopsy (if available) FVC ≥50% predicted Single breath DL CO 30–79% predicted Resting PaO 2 ≥55 mmHg (≤1500 m) or ≥50 mmHg (>1500 m) Main exclusion criteria: Medical conditions that might interfere with participation in study Known risk of bleeding or thrombosis Continuous oxygen supplementation at randomization (≥15 hours per day) Likely to require lung transplant during study (investigator’s opinion) Life expectancy for disease other than IPF <2.5 years (investigator’s opinion) Other investigational therapy <8 weeks prior to screening ATS, American Thoracic Society; ERS, European Respiratory Society; HRCT, high-resolution computed tomography. 1. Richeldi L, et al. N Engl J Med 2011;365:1079–1087; 2. ATS and ERS. Am J Respir Crit Care Med 2000;161:646–664.

TOMORROW: Baseline characteristics (1/2) BMI, body mass index. Richeldi L, et al. N Engl J Med 2011;365:1079–1087.

TOMORROW: Baseline characteristics (2/2) Richeldi L, et al. N Engl J Med 2011;365:1079–1087.

TOMORROW: Annual rate of decline in FVC Difference between nintedanib 150 mg bid and placebo: p=0.064 vs placebo (pre-specified primary multiplicity-corrected analysis [closed testing procedure]); p=0.014 vs placebo (pre-specified hierarchical testing procedure). Richeldi L, et al. N Engl J Med 2011;365:1079–1087.

TOMORROW: Preservation of health-related quality of life * *p=0.007 vs placebo. SGRQ, St George’s Respiratory Questionnaire. Richeldi L, et al. N Engl J Med 2011;365:1079–1087.

TOMORROW: Acute exacerbations *p=0.02 vs placebo. Richeldi L, et al. N Engl J Med 2011;365:1079–1087.

TOMORROW: Adverse events Richeldi L, et al. N Engl J Med 2011;365:1079–1087.

Conclusions Treatment with nintedanib 150 mg bid reduced the annual rate of decline in FVC by 68% compared with the placebo group A reduction in the incidence of acute exacerbations and preservation of quality of life were observed with nintedanib 150 mg bid versus placebo Nintedanib 150 mg bid had an acceptable safety profile, with a risk- benefit ratio that justified its investigation as a treatment for IPF in the INPULSIS Phase III trials Richeldi L, et al. N Engl J Med 2011;365:1079–1087.

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