Novartis announced topline results from its pivotal global Phase III LUSTER-1 and LUSTER-2 studies exploring the efficacy and safety of the investigational oral, once-daily, DP2 receptor antagonist fevipiprant (QAW039). The pooled analyses of the LUSTER trials did not meet the clinically relevant threshold for reduction in rate of moderate -to-severe exacerbation compared to placebo over a 52-week treatment period for either of the doses (150mg / 450 mg). The studies included patients who had inadequately controlled moderate-to-severe asthma (GINA Steps 4 and 5) despite receiving inhaled mid-to-high dose corticosteroids (ICS) and at least one additional controller. The totality of these results do not support further development of fevipiprant in asthma.
Fevipiprant was generally well tolerated, with treatment-emergent adverse events generally balanced across groups and comparable to placebo. Detailed efficacy and safety data from the LUSTER-1 and LUSTER-2 studies are being analyzed and will be submitted for presentation at an upcoming medical congress.
“While the results of the LUSTER studies with fevipiprant are disappointing, they meaningfully contribute to our understanding of the DP2 pathway in asthma. We are incredibly grateful to all the patients, their families and the investigators who participated in the studies and contributed greatly to this research,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis.
The pivotal replicate LUSTER-1 and LUSTER-2 studies are part of the VIBRANT Phase III program, which also includes the SPIRIT safety study and the supplemental replicate ZEAL-1 and ZEAL-2 studies. Topline results from ZEAL-1 and ZEAL-2 were announced in October 2019.
Novartis continues to invest into respiratory medicines with in-market products Xolair® (severe allergic asthma [SAA] and chronic spontaneous urticaria [CSU]), Ultibro® Breezhaler® (COPD), Phase III investigational products QVM149 (moderate-to-severe asthma), and QMF149 (moderate-to-severe asthma), as well as active research programs covering asthma, COPD and other areas of high unmet need, such as idiopathic pulmonary fibrosis and sarcoidosis.
