OFEV ® (nintedanib) TOMORROW trial results Last updated 08.09.2015 These slides are provided by Boehringer Ingelheim for medical to medical education only.

OFEV® (nintedanib)TOMORROW trial results

Last updated 08.09.2015

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 criteria2 <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 DLCO 30–79% predicted

• Resting PaO2 ≥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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