New data and analyses confirm the efficacy and safety of OFEV (nintedanib*) for the treatment of IPF beyond 52 weeks and for distinct subgroups

• Effect of nintedanib* on slowing disease progression was maintained for up to 76 weeks in the TOMORROW trial
• Long-term nintedanib* treatment in the INPULSIS^®-ON extension study confirms manageable safety and tolerability profile for up to 33 months
• Pooled analyses confirm efficacy of nintedanib* in patients with early IPF disease (forced vital capacity (FVC) > 90% predicted at baseline)
• Nintedanib* is the first targeted treatment for IPF to consistently demonstrate its efficacy in two identically designed Phase III trials and these long-term and pooled analyses confirm and strengthen its value for IPF patients

INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim announced new data and analyses for OFEV^® (nintedanib*) reinforcing its efficacy, safety and tolerability in a broad range of patients with idiopathic pulmonary fibrosis (IPF). These findings were presented at the American Thoracic Society (ATS) 2015 International Conference in Denver, United States. IPF is a debilitating and fatal lung disease, with a median survival of 2–3 years after diagnosis.¹ It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing.²

“As IPF is a life-threatening and progressive disease, patients will be on life-long treatment to manage their disease. It is important to assess and continue to monitor the efficacy and safety of OFEV^® in these patients,” said Professor Bruno Crestani, Professor of Pneumology and Deputy Dean for Research at the Paris Diderot University School of Medicine, France. “These data strengthen the evidence supporting the efficacy, safety and tolerability of OFEV^® and further our understanding of treating this complex disease.”

The new descriptive analyses on long-term treatment with nintedanib* in the Phase II TOMORROW trial (NCT01170065; abstract A1019)³ was presented at the conference. Following the placebo-controlled 52 week treatment phase of the trial (period 1), patients were given the option to continue blinded treatment (period 2) until the last patients had finalized the 52 week treatment period.

Overall, the analyses across both periods showed:

• Average observed change in decline in forced vital capacity (FVC) or the amount of air that can be exhaled after maximum inhalation (a measure of IPF disease progression), was consistently lower in the nintedanib* 150 mg bid group than in the comparator group (-3.1% vs. -6.3% from baseline to week 76)
• A lower proportion of patients in the nintedanib* 150 mg bid group versus the comparator group had at least 1 acute IPF exacerbation (a sudden and severe worsening of IPF) (4.7% vs. 19.5 % of patients)
• The safety and tolerability of nintedanib 150 mg bid was similar between periods 1 and 2.

Worldwide, IPF affects as many as 14–43 people per 100,000^4,5 , most commonly over the age of 50.⁶

Dr Martin Kolb, Director, Division of Respiratory, Department of Medicine, McMaster University, Canada added: “The unique data from post-hoc subgroup analyses from the pooled INPULSIS^® clinical trials demonstrate a consistent effect of OFEV^® in patients with different degrees of lung function impairment and patients with different radiologic patterns in imaging tests at baseline (no honeycombing and no confirmation of diagnosis in lung biopsy vs. patients with honeycombing and/or biopsy confirmation of diagnosis). The results presented highlight the importance of early detection and timely treatment of patients with IPF. In addition, the data presented at the conference includes a wide range of patient types which are representative of patients seen in clinical practice.”

In a post-hoc analysis of the INPULSIS^® trials (NCT01335464 and NCT01335477; abstract A1021),⁷ nintedanib* showed a consistent effect on reducing the annual rate of FVC decline, a measure of disease progression, whether patients had varying degrees of lung function impairment (i.e. FVC of > 90% predicted or ≤ 90% predicted.). Patients with early disease benefited in a similar way from treatment with nintedanib* compared to patients with more advanced disease.

The abstracts presented at the conference can be downloaded here by searching for the abstract numbers listed.

Two further abstracts were presented at the conference including:

• An analysis of the open-label extension of the Phase III INPULSIS^® trials – INPULSIS^®-ON (NCT01619085; abstract A1020)⁸ that confirmed the manageable safety and tolerability profile of nintedanib* in patients exposed to nintedanib* up to 33 months
• A post-hoc analysis of the INPULSIS trials (NCT01335464 and NCT01335477; abstract A1022),⁹ that showed the consistent effect of nintedanib* on reducing the annual rate of FVC decline, a measure of disease progression, in patients with different radiologic patterns at baseline, provided that they met the IPF diagnostic criteria required for trial participation.

*Nintedanib is approved under the brand name OFEV^® in the US and EU for use in patients with IPF. Nintedanib is under regulatory review by health authorities in other countries.

‡Adjudicated exacerbations was a pre-specified sensitivity analysis in the pooled data set. Time to first investigator-reported exacerbation was a secondary endpoint which was met in TOMORROW and INPULSIS^®-2 but not in INPULSIS^®-1.

~ ENDS ~

Please click on the link below for ‘Notes to Editors’ and ‘References’: https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/18_may_2015_ofev.html

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