Novartis reports Phase III IRIDIUM results of QVM149 therapy in patients with uncontrolled asthma

Novartis today announced that investigational, once-daily, inhaled QVM149 (indacaterol acetate, glycopyrronium bromide and mometasone furoate or IND/GLY/MF) was superior to QMF149 (indacaterol acetate and mometasone furoate or IND/MF) in improving trough forced expiratory volume in one second (FEV₁) after 26 weeks, meeting the primary endpoint of the Phase III IRIDIUM clinical trial.

This superior improvement in lung function was achieved in asthma patients who were uncontrolled on treatment with a long-acting beta agonist/inhaled corticosteroid (LABA/ICS)[1]. IND/GLY/MF was generally well tolerated and safety was comparable across treatment arms.

The key secondary endpoint was improvement in Asthma Control Questionnaire (ACQ-7) score for IND/GLY/MF versus IND/MF. Tested treatments delivered clinically meaningful improvements in this measure of symptoms from baseline at Week 26, but the key secondary endpoint was not met.

Among other secondary endpoints, IRIDIUM explored reduction of asthma exacerbation rates, where a substantial reduction was observed in moderate-to-severe and severe asthma exacerbation rates with IND/GLY/MF compared with an established LABA/ICS standard of care (twice-daily salmeterol xinafoate/fluticasone propionate 50/500 µg).

The IRIDIUM study was conducted to evaluate the efficacy and safety of medium and high doses of IND/GLY/MF (150/50/80 µg and 150/50/160 µg) versus respective medium and high doses of IND/MF (150/160 µg and 150/320 µg) delivered via the dose-confirming Breezhaler^® device, as well as versus twice-daily salmeterol/fluticasone (50/500 µg) delivered via the Accuhaler^®.

Patients with uncontrolled asthma on medium and high doses of LABA/ICS (as determined by pulmonary function testing and effects on asthma control) were included.

Despite being on treatment with LABA/ICS, nearly half of all patients with moderate-to-severe asthma are uncontrolled and at a higher risk of exacerbations, hospitalization or even death. For these patients, it is important to explore additional options to improve treatment outcomes and quality of life.
The initial results of IRIDIUM show us that QVM149 can improve lung function in these patients and potentially deliver substantial reduction in exacerbation rates, which can have a significant impact on the daily lives of people with uncontrolled asthma."
Dr. Huib Kerstjens, University Medical Center Groningen, The Netherlands

"Today's news represents a key milestone in the ongoing Novartis effort to reimagine asthma care for patients," said Linda Armstrong, MD, Respiratory Development Unit Head, Novartis Pharmaceuticals. "These positive initial IRIDIUM results are consistent with the Phase II outcomes presented at ATS earlier this year and strengthen the evidence to suggest that, if approved, medium and high dose QVM149 could be beneficial for people with asthma who are still uncontrolled after being treated with medium and high dose LABA/ICS."

The overall incidence of adverse events (AEs) and serious AEs in IRIDIUM was comparable among treatment groups and consistent with the known safety profile of the monocomponents[1].
Detailed results from the IRIDIUM trial will be presented at upcoming medical congresses.

As previously announced, the regulatory submission for QVM149 was accepted for review by the European Medicines Agency earlier this year.