Novartis has announced that investigational, once-daily, fixed-dose inhaled QMF149 (indacaterol acetate and mometasone furoate or IND/MF) was superior to mometasone furoate (MF) in improving trough forced expiratory volume in one second (FEV1) after 26 weeks, meeting the primary endpoint of the Phase III PALLADIUM clinical trial.
This superior improvement in lung function was achieved in patients with asthma who remain uncontrolled on treatment with inhaled corticosteroid (ICS) at medium or high dose, or long-acting beta agonist (LABA)/ICS at low dose. IND/MF was generally well tolerated, and safety was comparable across treatment arms.
The key secondary endpoint, improvement in Asthma Control Questionnaire (ACQ-7), was also met for combined doses of IND/MF when compared to combined doses of MF, with a statistically significant improvement of asthma control achieved from baseline at Week 261. The PALLADIUM study was conducted to evaluate the efficacy and safety of medium and high doses of QMF149 (150/160μg and 150/320μg) delivered via the dose-confirming Breezhaler® device versus two respective medium and high doses of MF (400 μg and 800μg) delivered via Twisthaler® in patients with asthma who were uncontrolled on medium or high dose ICS or low dose LABA/ICS (as determined by pulmonary function testing and effects on asthma control). The PALLADIUM study also included an additional secondary comparison of high dose IND/MF delivered via the dose-confirming Breezhaler® device with twice daily salmeterol xinafoate/fluticasone propionate (50/500μg) delivered via the Accuhaler®.
“Nearly half of all patients with moderate-to-severe asthma remain uncontrolled and continue to suffer with regular symptoms and exacerbations,” said Dr Richard van Zyl-Smit, Associate Professor, Head of the Lung Clinical Research Unit, University of Cape Town Lung Institute, and Consultant Pulmonologist, Groote Schuur Hospital, Cape Town, South Africa. “Promising results from PALLADIUM in both doses of the indacaterol and mometasone furoate combination provide evidence for the efficacy and safety profile of QMF149 for the treatment of asthma. If approved, the easy-to-use, dose-confirming, once-daily device adds an additional and important option for clinicians treating asthma. I believe that this new fixed-dose combination has the potential to improve and simplify the lives of many patients with uncontrolled asthma.”
“We are very pleased that PALLADIUM demonstrated the efficacy and safety of medium and high doses of QMF149, delivered via our dose-confirming Breezhaler® device,” said Linda Armstrong, MD, Respiratory Development Unit Head, Novartis Pharmaceuticals. “These results complement the findings of the Phase III QUARTZ study for a lower dose of QMF149 and provide additional evidence of the benefits of this combination treatment across the full dose range. We look forward to announcing more data from the PLATINUM clinical development program.”
The overall incidence of adverse events (AEs) and serious AEs in PALLADIUM was comparable among treatment groups and consistent with the known safety profile of the monocomponents.
The detailed results from the PALLADIUM trial will be presented at upcoming medical congresses. As previously announced, the regulatory submission for QMF149 was accepted for review by the European Medicines Agency earlier this year.