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- Once-daily QMF149 met primary endpoint of lung function improvement and key secondary endpoint of asthma control improvement versus mometasone furoate1
- QMF149 showed improvement in peak expiratory flow, exacerbation rates, rescue medication use versus mometasone furoate among other secondary endpoints1
- Improvement in lung function was observed in high dose QMF149 versus a high dose LABA/ICS standard-of-care in certain additional secondary endpoints1
Basel, December 6, 2019 - Novartis today announced data from the 52-week pivotal Phase III PALLADIUM clinical trial which demonstrated that QMF149, 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 endpoint1. 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 monocomponents1. PALLADIUM is part of PLATINUM, the Novartis Phase III clinical development program supporting the development of QVM149 and QMF149. 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 ‘g; 150/320 ’g) demonstrated significant improvements compared to MF (400 ‘g once-daily, 400 ’g 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.
Analyses of other lung function endpoints showed greater improvements for IND/MF compared to MF in both morning and evening Peak Expiratory Flow (PEF). Reductions in daily rescue medication use and exacerbation rates were also observed.
In the secondary analyses (no adjustments for multiplicity) of comparison to SFC, high dose IND/MF showed improvements in trough FEV1 [0.048 L; p=0.040] at 52 weeks. In asthma control, high dose IND/MF and SFC were comparable with a difference in ACQ-7 score of 0.010 [p=0.824]. Improvements were observed in both morning and evening PEF [Morning: 13.8 L/min; p<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].
"At Novartis, we are continually striving to help patients with asthma, and we are delighted to present these positive new data showing important benefits for patients, as a part of that journey," said Linda Armstrong, MD, Respiratory Development Unit Head, Novartis Pharmaceuticals. "If approved, QMF149, when delivered via our dose-confirming Breezhaler device, has the potential to become an important once-daily treatment option for patients with uncontrolled asthma. With the availability of PALLADIUM outcomes, we now have even more evidence of the potential benefits of this combination treatment, which could benefit millions of people with uncontrolled asthma."
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 monocomponents1.
As previously announced, the regulatory submission for IND/MF was accepted for review by the European Medicines Agency earlier this year.
About the PALLADIUM study2
PALLADIUM is a multicenter, randomized, 52-week treatment, double-blind, triple-dummy,
parallel-group study, to assess the efficacy and safety of the indacaterol acetate and mometasone furoate (IND/MF) combination compared with mometasone furoate (MF) alone in patients with asthma.
PALLADIUM included 2,216 male and female patients (including 107 adolescents, aged