Date: 2015-05-20
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentaion of results at the ATS International Conference, May 15-20, 2015, in Denver
Company: Novartis (Switzerland)
Product: QVA149 (indacaterol/glycopyrronium bromide)
Action
mechanism: long-acting beta2-agonist (LABA)/long-acting muscarinic antagonist (LAMA). QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) is an inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA) indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237).
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial
details: The EXPEDITION program consisted of trials, including FLIGHT 1 and 2, which were identical 12-week, multi-center, randomized, double-blind, parallel-group, placebo-and active-controlled studies to assess the efficacy, safety, and tolerability of QVA149 (indacaterol/glycopyrronium bromide) in moderate-to-severe COPD patients. The primary objective was to compare QVA149 27.5/12.5 mcg, administered twice-daily, to its monotherapy components in terms of lung function (FEV1 AUC0-12h) at week 12. Breathlessness was measured by the transition dyspnea index (TDI) total score and overall quality of life by the St George's Respiratory Questionnaire (SGRQ) total score.
FLIGHT 3 was a 52-week randomized, double-blind, parallel-group study to assess the safety and tolerability of QVA149 27.5/12.5 mcg, administered twice-daily, compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients. The primary endpoint was the overall rate of adverse events reported during the study.
GEM 1 and 2 were 12-week multi-center, randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of NVA237 (glycopyrronium bromide) 12.5 mcg, administered twice-daily, in moderate-to-severe COPD patients. The primary objective was to compare NVA237 to placebo in terms of lung function (FEV1 AUC0-12h) after 12 weeks of treatment.
Latest
news: * On May 20, 2015, Novartis announced positive results from two pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM programs met their primary and secondary endpoints, and the results were presented for the first time at the ATS International Conference, May 15-20, 2015, in Denver, US. Data from the EXPEDITION program demonstrated that QVA149, administered twice-daily, improved lung function (FEV1 AUC0-12h) compared to placebo and its individual monocomponents, indacaterol and glycopyrronium bromide (p<0.001), after 12 weeks of treatment, meeting its primary objective. Further findings also confirmed that Novartis' dual bronchodilator improved breathlessness, overall quality of life and COPD rescue medication use. It also showed significant improvements in FEV1 at 5 min and 15 min compared to placebo according to new pooled data from over 2,000 patients. The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients. Improvements in overall health status, a secondary endpoint based on the St George's Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA149 compared to placebo at Week 12. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies. In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo; meeting its primary objective. An improvement in health status was also observed in patients at Week 12. The adverse events reported for NVA237 were comparable to placebo across the GEM studies. Data from the EXPEDITION and GEM programs are expected to be presented at major medical congresses later this year.
In the GEM 1 and 2 studies, NVA237, administered twice-daily, demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at week 12 in moderate-to-severe COPD patients compared to placebo (p<0.001); meeting its primary objective[8],[9]. Improvements in COPD symptoms, quality of life and rescue medication use in patients with moderate-to-severe airflow limitation were also observed.
The safety profiles of QVA149, its monotherapy components and placebo were broadly similar across the EXPEDITION studies, as was NVA237 to indacaterol and placebo in the GEM studies.
* On January 8, 2015, Novartis announced positive top-line results from the pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) to support New Drug Applications (NDAs) with the FDA for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM clinical trial programs met their primary and secondary endpoints.
