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2:18 PM Boehringer Ingelheim to Present Highly Anticipated Data from Landmark TIOSPIR™ Trial, and Their Respiratory Pipeline Products in COPD, Asthm |
INGELHEIM, Germany - Monday, September 2nd 2013 [ME NewsWire]
(BUSINESS WIRE)--For media outside the UK, US and Canada
Results of COPD Phase III landmark trial TIOSPIR™ comparing safety and efficacy of SPIRIVA® Respimat® versus SPIRIVA® HandiHaler®
Phase III trial results on investigational compound olodaterol* Respimat® as once-daily maintenance bronchodilator monotherapy in COPD
Phase III data from MezzoTinA-asthma® trials evaluating the efficacy and safety of tiotropium† Respimat® in asthma patients symptomatic on moderate-dose maintenance inhaled corticosteroid (ICS) therapy
Results of LUX-Lung 6 Phase III trial demonstrating superiority of afatinib‡ over standard chemotherapy in lung cancer patients with EGFR mutations1,2
Results from TIOSPIR™ (Tiotropium Safety and Performance in Respimat), one of the largest global chronic obstructive pulmonary disease (COPD) trials ever conducted, will be presented for the first time at the Annual Congress of the European Respiratory Society (ERS), in Barcelona, Spain, September 7-11, 2013.
The highly anticipated three year TIOSPIR™ trial assessed the relative safety and efficacy of the two marketed SPIRIVA® formulations – SPIRIVA® Respimat® Soft Mist™ Inhaler 2.5 µg (once a day, 2 puffs§) versus SPIRIVA HandiHaler® 18 μg.** TIOSPIR™ included more than 17,000 COPD patients from 50 countries and, with broad inclusion criteria, featured a real-world study population that closely reflected the types of COPD patients physicians see every day. Boehringer Ingelheim is pleased to be sharing these results with the scientific community at the ERS Annual Congress, the largest respiratory meeting in the world.
In addition, Boehringer Ingelheim will present data from the olodaterol Respimat® monotherapy Phase III clinical trial programme, which involves more than 3,000 patients with moderate to very severe COPD (GOLD 2-4). Results will be presented on lung function (FEV1) efficacy, and the symptomatic benefit of olodaterol Respimat®, as well as its safety. Olodaterol Respimat® has been designed to provide bronchodilatory benefits to COPD patients who need an alternative treatment option.
Asthma
Further highlights from abstracts presented at ERS include Phase III data from the MezzoTinA-asthma® trials – designed to evaluate the efficacy and safety of tiotropium Respimat® in asthma patients who remain symptomatic despite treatment with moderate-dose maintenance ICS therapy (400-800 μg budesonide equivalent). The results include lung function, asthma control and safety data, adding to evidence from the on-going Phase III trial programme that has shown efficacy and safety of tiotropium Respimat® in patients with asthma who continue to experience symptoms despite treatment with at least ICS/LABA††.3
Treatment of respiratory diseases has been a major area of focus for Boehringer Ingelheim for more than 90 years and significant resources are dedicated to research in this field. In addition to novel treatments for COPD, Boehringer Ingelheim has also branched out into developing treatment options for other airway diseases, including asthma, lung cancer, idiopathic pulmonary fibrosis (IPF) and other respiratory diseases.
Lung cancer
The latest clinical research data for afatinib, a targeted cancer therapy from Boehringer Ingelheim’s own research and development pipeline, will be presented at ERS. The LUX-Lung 6 trial investigates afatinib in late-stage lung cancer patients who have a specific mutation of the receptor for the epidermal growth factor (EGFR). LUX-Lung 6 is the second Phase III trial to show superiority of afatinib over standard chemotherapy in patients with EGFR mutation-positive non-small cell lung cancer (NSCLC).1,2
More people worldwide die from lung cancer than from any other form of cancer. It accounts for 1.6 million new cancer cases annually. The prevalence of tumours harbouring EGFR mutations is between 10-15% in Caucasian and 40% in Asian NSCLC patients.4
Afatinib is approved in the US under the brand name GILOTRIF™ and in Taiwan under the brand name GIOTRIF® for use in patients with distinct types of non-small cell lung cancer. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for afatinib and regulatory reviews by health authorities in other countries are ongoing.
IPF
Boehringer Ingelheim is conducting Phase III clinical research in IPF, a rare and deadly disease affecting between 14 and 43 people per 100,000 worldwide.5 Nintedanib‡‡ is an investigational small molecule tyrosine kinase inhibitor (TKI) currently being studied in two pivotal Phase III clinical trials (INPULSIS™-1 and 2) for the treatment of IPF. Nintedanib has been awarded orphan-drug status in the EU, Japan and US. In June 2013, nintedanib was granted Fast Track designation by the US Food and Drug Administration (FDA). The FDA's Fast Track program is designed to expedite the development and review of drugs to treat serious life-threatening diseases and to meet an unmet medical need.6
An educational website for health care professionals to support early diagnosis of IPF is available online following this link: www.soundsofipf.com
The ERS annual congress is the largest respiratory meeting in the world and is an important platform for professional exchange. Boehringer Ingelheim’s abstracts in respiratory research can be accessed through the ERS website after 31 August, www.erscongress2013.org.
Boehringer Ingelheim will present a total of 21 abstracts at ERS and host three media briefings to contextualise important data results throughout the congress, underscoring the company’s focus on finding answers to the challenges faced by patients living with lung disease.
Key sessions are highlighted below. If you would like to know more about planned Boehringer Ingelheim media activities at ERS, please contact Linda Calandra, Boehringer Ingelheim, Corporate Communications, Media + PR: press@boehringer-ingelheim.com or visit the online resource for journalists www.newshome.com
COPD: SPIRIVA® (tiotropium)
Topic
Lead Author
Presentation details
TIOSPIR™: Large scale trial of tiotropium Respimat® vs HandiHaler® in patients with COPD
R. Wise
Date: Sunday 8 September Time: 12:50–14.40 Venue: Hall 1-13 Session type: Poster
Cardiac events among patients with CV comorbidities: Pooled analysis of COPD trials comparing tiotropium with salmeterol
K.M. Beeh
Date: Sunday 8 September Time: 12.50-14.40 Venue: Hall 1-13 Session type: Poster
Influence of patient baseline characteristics and concomitant medication on outcomes in long-term trials of COPD: Analysis of the UPLIFT® trial
M. Decramer
Date: Sunday 8 September Time: 12.50-14.40 Venue: Hall 1-13 Session type: Poster
Comparison of cardiovascular safety in a pooled analysis of COPD trials comparing tiotropium with salmeterol
C. Vogelmeier
Date: Sunday 8 September Time: 12.50-14.40 Venue: Hall 1-13 Session type: Poster
Effect of tiotropium on spontaneous expiratory flow-volume curves during exercise in GOLD 1&2 COPD
A. Porszasz
Date: Sunday 8 September Time: 12.50-14.40 Venue: Hall 1-13 Session type: Poster
Comparison of the pharmacokinetics and pharmacodynamics of once daily tiotropium Respimat® and tiotropium HandiHaler® in COPD patients
B. Sharma
Date: Tuesday 10 September Time: 14.45-16.45 Venue: Room 5.1 Session type: Oral
Influence of the seasons on exacerbation characteristics in a cohort of COPD patients (EXACO study)
A. Cortot
Date: Tuesday 10 September Time: 12.50-14.40 Venue: Hall 1-30 Session type: Poster
First dose response to tiotropium in COPD: Impact on dyspnea, lung hyperinflation and distal airways
J. Pastre
Date: Tuesday 10 September Time: 12.50-14.40 Venue: Hall 1-26 Session type: Poster
COPD: Olodaterol
Topic
Lead Author
Presentation details
Lung function efficacy of olodaterol QD delivered via Respimat® in COPD patients: results from two 48-week studies
G.T. Ferguson
Date: Sunday 8 September Time: 08.30–10.30 Venue: Room 2.4 Session type: Oral
Lung function efficacy of olodaterol QD delivered via Respimat® vs. placebo and formoterol BID in patients with COPD: two 48-week studies
A. Koch
Date: Sunday 8 September Time: 12.50–14.40 Venue: Hall 1-13 Session type: Poster
Symptomatic benefit of olodaterol QD delivered via Respimat® vs. placebo and formoterol BID in patients with COPD: combined analysis from two 48-week studies
A. Koch
Date: Sunday 8 September Time: 12.50–14.40 Venue: Hall 1-13 Session type: Poster
The 24-h FEV1 time profile of olodaterol QD delivered via Respimat® in COPD: results from two 6-week studies
P. Lange
Date: Tuesday 10 September Time: 14.45–16.45 Venue: Room 5.1 (CC5) Session type: Oral
48-week administration of olodaterol QD via Respimat® vs. placebo and formoterol BID in patients with COPD: pooled safety analysis.
L. McGarvey
Date: Tuesday 10 September Time: 10.45–12.45 Venue: Room 3.8 Session type: Poster discussion
Asthma
Topic
Lead Author
Presentation details
Tiotropium as add-on to inhaled corticosteroids significantly improves asthma control as reflected by the ACQ responder rate
H.A.M. Kerstjens
Date: Tuesday 10 September Time: 12:50-14:40 Venue: Hall 1-25 Session type: Poster
Tiotropium as add-on therapy to inhaled corticosteroids for patients with symptomatic asthma: Lung function and safety
H.A.M. Kerstjens
Date: Tuesday 10 September Time: 15.00 Venue: Room 5.1 Session type: Oral
Phase III trial of tiotropium as add-on therapy to low-dose inhaled corticosteroids for patients with symptomatic mild persistent asthma: design and planned analyses
P. Paggiaro
Date: Tuesday, 10 September Time: 12:50-14:40 Venue: Hall 1-25 Session type: Poster
Lung Cancer
Topic
Lead Author
Presentation details
LUX-Lung 6: A randomized, open-label, phase III study of afatinib versus gemcitabine/cisplatin as first-line treatment for Asian patients with EGFR mutation-positive advanced adenocarcinoma of the lung
Y.L. Wu
Date: Sunday 8 September Time: 10.45-12.45 Venue: Room 2.3 Session type: Oral
* Olodaterol (Striverdi®) Respimat® is approved for use in COPD in Canada and Russia; approval and regulatory reviews by health authorities in the US, Europe and other countries are pending
† Tiotropium delivered by Respimat® is not approved for the treatment of asthma
‡ In the USA and in Taiwan, afatinib is approved for use in patients with distinct types of non-small cell lung cancer. Afatinib is under regulatory review by EMA and by health authorities in other countries
§ This is the marketed dose referred to in the NEJM TIOSPIR™ publication as tiotropium Respimat® 5 µg
** A third treatment arm included an investigational dose of SPIRIVA® Respimat®, 1.25 µg (once a day, 2 puffs), referred to in the NEJM TIOSPIR™ publication as tiotropium Respimat® 2.5 µg
†† Long-acting beta2-agonists
‡‡ Please note: nintedanib is not licensed for the treatment of idiopathic pulmonary fibrosis and is not yet approved
Notes to Editors: www.newshome.com/respiratory/ers-2013-curtain-raiser.aspx
References
1 Wu YL, Zhou C, Hu CP, et al. LUX-Lung 6: A randomized, open-label, Phase III study of afatinib (A) vs. gemcitabine/cisplatin (GC) as first-line treatment for Asian patients (pts.) with EGFR mutation-positive (EGFR M+) advanced adenocarcinoma of the lung. (Abstract #8016) at American Society of Clinical Oncology, Chicago, June 2, 2013.
2 Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008;26:3543–51.
3 Kerstjens HAM, Engel M, Dahl R, et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med 2012; 367 (13): 1198-1207.
4 Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010;127:2893-917.
5 Raghu G, Weycker D, Edelsberg J, et al. Incidence and prevalence of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2006;174:810-6.
6 FDA. Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review. Accessed at: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm. Accessed August 2013.
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Name: Linda Calandra
55216 Ingelheim/Germany
Phone: +49 6132 – 77 3519
Email: press@boehringer-ingelheim.com
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