In this multicenter, randomized, double-blind phase III QUARTZ study (ClinicalTrials.gov Identifier: NCT02892344), once-daily, low dose IND/MF (QMF149) 150/80 Mu g met the primary and key secondary endpoints (trough FEV1 and ACQ-7 score at Week 12, respectively) when compared to once-daily mometasone furoate (MF), an ICS, delivered via the Twisthaler® device (200 Mu g) in both adult and adolescent patients with asthma[1].
Patients included in the QUARTZ study were inadequately controlled (symptomatic as defined by Asthma Control Questionnaire, ACQ-7>1.5) on low dose ICS (with or without an additional maintenance treatment)[1].
“Despite the number of available treatments, many patients’ lives remain impacted by their asthma,” said Linda Armstrong, MD, Respiratory Development Unit Head. “The QMF149 results of the QUARTZ study complement the recently presented phase II data of QVM149 at the 2019 American Thoracic Society Congress, showing superiority of QVM149 to the current standard of care. We look forward to seeing the rest of the data from the PLATINUM clinical trial program.”
IND/MF demonstrated statistically significant improvements in lung function as measured by trough FEV1 (volume of air that can be forced out in one second after taking a deep breath, which is measured approximately 24 hours after the last administration of study drug) compared to MF after 12 weeks of treatment in adult and adolescent patients with inadequately controlled asthma [Least squares (LS) mean treatment difference: 0.182 L, 95% CI: 0.148, 0.217; p < 0.001][1]. In addition, clinically meaningful lung function benefit for IND/MF is supported by improvements in evening PEF of 26.1 L/min compared to MF alone (95% CI, 21.0, 31.2).
IND/MF also demonstrated statistically significant improvements in asthma control compared with MF, as measured by ACQ-7 after 12 weeks of treatment (LS mean treatment difference: -0.218, 95% CI: -0.293, -0.143; p < 0.001)[1]. In addition, clinically meaningful improvement in ACQ-7 is supported by a responder analysis, in which the QMF149 group had a greater proportion of responders (improvement in ACQ-7 >=0.5) compared to the MF group (74.7% vs 64.9%, respectively (odd ratio: 1.69, 95% CI: 1.23, 2.33).
Both treatments (IND/MF and MF) were generally well tolerated. The overall incidence of adverse events (AEs) was lower in the IND/MF group compared with the MF group (32.3% vs. 38.3%, respectively). The majority of AEs in both treatment groups were mild to moderate (>90% AEs) in severity, and were comparable between the treatment groups. The incidence of severe AEs was low and were reported in 7 (1.8%) patients in the QMF149 group compared with 14 (3.5%) patients in the MF group[1].
“I am very pleased with the results of the QUARTZ study looking at the efficacy and safety of the fixed dose combination of indacaterol and mometasone furoate,” Dr Oliver Kornmann, Pulmonary Department, Internal Medicine, University Hospital Mainz, Germany. “Fixed-dose combination inhalers may offer advantages to people with asthma by simplifying complex inhaler regimens, especially when they can be dosed once daily which can therefore further reduce the burden of the disease.”
The combination of indacaterol acetate and mometasone furoate (IND/MF) is currently in development for the treatment of inadequately controlled asthma (who remain symptomatic despite current treatment) and the regulatory submission of this investigational once daily inhaled combination treatment has recently been accepted for review by the European Medicines Agency (EMA). It combines the bronchodilation of the ultra-LABA indacaterol acetate (a long acting beta agonist [LABA]) with the anti-inflammatory mometasone furoate (an ICS) in a precise once-daily formulation, delivered with the dose-confirming Breezhaler® device. Mometasone furoate is exclusively licensed to Novartis from a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA, for use in QMF149.
Source: Company Press Release