Novartis provides update on LUSTER Phase III studies in patients with uncontrolled GINA 4/5 asthma

  • Patients & Caregivers
  • Healthcare Professionals
  • Society & ESG

  • Pooled analyses of LUSTER 1 and 2 did not support further development of Fevipiprant in asthma as a primary indication
  • Fevipiprant was well tolerated with adverse events balanced across treatment groups

Basel, Switzerland, December 16, 2019 - Novartis today announced topline results from its pivotal global Phase III LUSTER-11 and LUSTER-22 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 meet3 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 placebo3. 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-11 and LUSTER-22 studies are part of the VIBRANT Phase III program, which also includes the SPIRIT4 safety study and the supplemental replicate ZEAL-15 and ZEAL-26 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 7 (severe allergic asthma [SAA] and chronic spontaneous urticaria [CSU]), Ultibro Breezhaler 8 (COPD), Phase III investigational products QVM1499 (moderate-to-severe asthma), and QMF14910 (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.

About Fevipiprant
Fevipiprant is an investigational, novel, steroid-free once-daily pill. It blocks the DP2 pathway11, a potentially important regulator of the asthma inflammatory cascade12.

About LUSTER-1 and LUSTER-21,2
LUSTER-1 and LUSTER-2 (CQAW039A2307, NCT02555683 and CQAW039A2314, NCT02563067) were 52-week, randomized, multi-center, double-blind, placebo-controlled, replicate Phase III studies in patients with moderate-severe asthma. The patient population included 894 (LUSTER-1) and 877 (LUSTER-2) patients aged