Novartis burnishes prospects for its big asthma drug with positive PhIII data from a similar treatment
Novartis has some good news to share on the asthma front as it sets the scene for a blockbuster Phase III readout.
The star today is low dose QMF149, a combo of the long-acting beta agonist (LABA) indacaterol acetate and the corticosteroid mometasone furoate. The once-daily inhalation beat a corticosteroid monotherapy on all primary and secondary endpoints, including forced expiratory volume and asthma control as measured by a questionnaire.
The QUARTZ study represents a prelude to much more significant results for QVM149, one of seven potential blockbusters CEO Vas Narasimhan has tapped for 2019 (with 18 more to follow in the years to come). QVM149 is a triple that adds a long-acting muscarinic receptor antagonist (LAMA) to the two active ingredients in QMF149. Both the triple and the double are delivered with the Breezhaler device, which Novartis has used for COPD.
Just days ago, Novartis teased some Phase II data showing that QVM149 beat Advair — the standard-of-care and one of GlaxoSmithKline’s big money makers for years — head-to-head. Investigators noted that both doses of the drug notched statistically significant improvements of peak FEV1 compared to twice-daily salmeterol/fluticasone propionate.
For the 12-week trial with QMF149, on the other hand, lung function was measured by trough FEV1 — taken approximately 24 hours after the last administration of the drug, as opposed to within a few hours in peak FEV1. The least squares mean treatment difference was 0.182 L, (95% CI: 0.148, 0.217; p < 0.001). There were also improvements in evening peak expiratory flow of 26.1 L/min compared to MF alone (95% CI, 21.0, 31.2).
In terms of asthma control, patients on the combo scored an average of 0.218 lower on a 7-point questionnaire than the comparator arm after 12 weeks (95% CI: -0.293, -0.143; p < 0.001). In addition, a greater proportion among them had an improvement of or above 0.5 on the questionnaire, which tracks symptoms. (74.7% vs 64.9%, respectively; odd ratio: 1.69, 95% CI: 1.23, 2.33).
“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,” said Oliver Kornmann at the University Hospital Mainz, Germany.
Novartis has submitted both QMF149 and QVM149 to the EMA for review while expecting late-stage data on QVM149.