Novartis AG (NVS - Free Report) announced mixed results from the phase III IRIDIUM study on investigational, once-daily, inhaled QVM149 (indacaterol acetate, glycopyrronium bromide and mometasone furoate or IND/GLY/MF).
QVM149 demonstrated statistically significant improvement in lung function as compared to QMF149 (indacaterol acetate and mometasone furoate or IND/MF), thereby meeting the primary endpoint in asthma patients, whose disease was uncontrolled on treatment with a long-acting beta agonist/inhaled corticosteroid (LABA/ICS).
However, the key secondary endpoint — improvement in the Asthma Control Questionnaire (ACQ-7) score for IND/GLY/MF versus IND/MF — was not met.
We note that IRIDIUM is the largest study in the phase III PLATINUM clinical development program, which evaluates inhaled combinations — QVM149 and QMF149.
We remind investors that the regulatory submission for QVM149 was accepted for review by the European Medicines Agency earlier this year.
Concurrently, Novartis announced positive results from the late-stage study on investigational, once-daily, fixed-dose inhaled QMF149.
Results showed that once-daily QMF149 demonstrated superior improvement in lung function versus mometasone furoate (MF), meeting the primary endpoint in the phase III PALLADIUM study. This was achieved in asthma patients, whose disease was uncontrolled on treatment with inhaled corticosteroid (ICS) at medium or high dose, or long-acting beta agonist (LABA)/ICS at low dose.
QMF149 also met the key secondary endpoint of improvement in the Asthma Control Questionnaire (ACQ-7) as combined doses of IND/MF showed a statistically significant improvement of asthma control achieved from baseline at Week 26 when compared to combined doses of MF.
The approval of these candidates will strengthen Novartis’ asthma care franchise. The company’s Xolair is already approved for the treatment of moderate-to-severe, or severe, persistent allergic asthma. The company has a collaboration agreement with Roche (RHHBY - Free Report) for the same in the United States.
Earlier, Novartis announced results from the MONALEESA-3 study, which showed that breast cancer drug Kisqali (ribociclib) achieved statistically significant improvement in overall survival (OS).
MONALEESA-3 evaluated the efficacy and safety of CDK4/6 inhibitor Kisqali plus Faslodex in postmenopausal women with hormone-receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
This is the second phase III study, in which the Kisqali combination therapy met the secondary endpoint of OS at the pre-planned interim analysis. Per Novartis, Kisqali is the only CDK4/6 inhibitor to show positive OS in two pivotal phase III trials, consistently demonstrating approximately 30% reduction in the risk of death.
Kisqali is already approved in the United States and Europe as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor.
Novartis is evaluating the drug in early breast cancer. The NATALEE study is a phase III clinical study of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology.
However, competition is stiff in the breast cancer market with the likes of Eli Lilly’s (LLY - Free Report) Verzenio and Pfizer’s (PFE - Free Report) Ibrance.
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