Phase III PALLADIUM data on new inhaled dual combination QMF 149 show significant improvement across key asthma outcomes versus monotherapy.- Novartis

Novartis announced data from the 52-week pivotal Phase III PALLADIUM clinical trial which demonstrated that QMF 149, a once-daily fixed-dose combination of indacaterol acetate and mometasone furoate (IND/MF) in development, was superior to mometasone furoate (MF) at medium and high doses in improving lung function, meeting the primary endpoint. Statistically significant superiority compared to MF alone was also demonstrated in the key secondary endpoint of improvement in asthma control. Other secondary analyses of efficacy endpoints showed improvements in lung function when comparing IND/MF to a LABA/ICS standard-of-care (salmeterol xinafoate/fluticasone propionate � SFC). Safety findings were generally comparable among treatment groups and consistent with the known safety profile of the monocomponents.

PALLADIUM is part of PLATINUM, the Novartis Phase III clinical development program supporting the development of QVM 149 and QMF 149. These key results were presented at the British Thoracic Society Winter Meeting, in London, UK, and will be submitted for publication in a scientific journal.

In the primary endpoint, medium and high doses of IND/MF (150/160 ug; 150/320 ug) demonstrated significant improvements compared to MF (400 ug once-daily, 400 ug twice-daily respectively) in trough Forced Expiratory Volume in one second (FEV1) at Week 26 [Medium: 0.211 L; p<0.001][high: 0.132 l; p><0.001]. the key secondary endpoint of improvement in asthma control questionnaire (acq-7) at week 26 was also met for combined doses of ind mf compared to combined doses of mf [-0.209; p><0.001]. these positive results were also observed at week 52.>

�Results from the PALLADIUM trial show that indacaterol and mometasone furoate combined is superior to mometasone furoate alone in improving lung function and asthma control; as well as showing reduction in exacerbation rates in a population of patients whose asthma is uncontrolled on a medium to high dose ICS or a low dose combination of LABA/ICS. Despite current treatments, we know that around 40-45% of patients with asthma remain uncontrolled at GINA Step 3 to 5, highlighting the need for new treatment options to achieve optimal disease control in these patients,� 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.

<0.001][evening: 9.1 l min; p="0.002]," and percentage of rescue medication free days over 52 weeks [4.3; p="0.034]" in patients treated with high dose ind mf versus sfc. high dose ind mf also showed faster onset of action over sfc as demonstrated by fev1 measurement at 5 minutes on day 1 [0.055 l; p><0.001].>

The overall incidence of adverse events (AEs) and serious AEs (SAEs) for IND/MF in the PALLADIUM study was comparable among treatment groups and consistent with the known safety profile of the monocomponents. As previously announced, the regulatory submission for IND/MF was accepted for review by the European Medicines Agency earlier this year.