Novartis Announces Phase III Success for QMF149 in Asthma, Demonstrating Superiority Over Standard Therapies

Today, Novartis announced that its combination therapy QMF149 met the primary and key secondary endpoints in the pivotal Phase 3 PALLADIUM clinical trial for the treatment of patients with asthma. QMF149 significantly improved lung function in patients, demonstrating superior efficacy compared to mometasone furoate monotherapy and the standard therapy salmeterol xinafoate/fluticasone propionate (SFC).

Asthma is a chronic lung disease. Inflammation and narrowing of the airways in patients lead to recurrent symptoms such as chest tightness, shortness of breath, and coughing. It can occur at any age. If asthma symptoms are not well controlled, they impose a significant burden on patients’ personal health and finances. According to statistics released in a press release, although multiple asthma therapies have been approved, more than 40% of asthma patients still do not have their symptoms effectively controlled.

As a once-daily, fixed-dose introductory combination medication, QMF149 comprises two active ingredients: the long-acting β2-adrenergic agonist (LABA) indacaterol acetate and the inhaled corticosteroid (ICS) mometasone furoate (MF). Currently, the marketing authorization application for this therapy is under review by the European Medicines Agency (EMA).

▲PALLADIUM Trial Design (Image source: Reference [2])

In the 52-week, randomized, double-blind, active-controlled Phase 3 PALLADIUM trial, 2,216 adult patients with asthma who had previously received LABA/ICS therapy at various doses but whose symptoms remained inadequately controlled were randomized to receive either medium/high-dose QMF149 or MF/SFC.

The trial results demonstrated that, compared with the MF active control group, QMF149 not only significantly improved patients’ lung function but also enhanced forced expiratory volume in one second (FEV1), thereby meeting the primary endpoint of the study. Furthermore, patients in the treatment group showed improved asthma control as reflected by Asthma Control Questionnaire-7 (ACQ-7) scores, along with improvements in morning and evening peak expiratory flow (PEF). QMF149 reduced the daily use of rescue medication and slowed disease progression. Compared with the SFC active control group, patients receiving QMF149 also exhibited improvements in lung function and other metrics, achieving the key secondary endpoints of the trial.

“Novartis is committed to helping patients with asthma, and we are pleased to present these latest data, which are highly significant for patients,” said Dr. Linda Armstrong, Head of Respiratory Development at Novartis. “If approved, QMF149 will be administered via the Breezhaler inhaler with a dose-confirmation mechanism, potentially providing an important once-daily treatment option for patients with inadequately controlled asthma. The positive results from the PALLADIUM trial further demonstrate the potential efficacy of this combination therapy, which could benefit millions of patients with poorly controlled asthma.”

References:

[1] Novartis Phase III data on new inhaled dual combination QMF149 show significant improvement across key asthma outcomes versus monotherapy，Retrieved December 6, 2019, from https://www.globenewswire.com/news-release/2019/12/06/1957160/0/en/Novartis-Phase-III-data-on-new-inhaled-dual-combination-QMF149-show-significant-improvement-across-key-asthma-outcomes-versus-monotherapy.html

[2] A Phase III study assessing the efficacy and safety of two doses of QMF149 (indacaterol acetate[IND]/mometasone furoate [MF]) delivered via the dose-confirming Breezhaler® device in patients with uncontrolled asthma, Retrieved December 6, 2019, from https://novartis.gcs-web.com/static-files/767e727b-0720-4663-abf4-d2d4a7101b7c

▽Follow [WuXi AppTecDe】WeChat Official Account