Abstract selected for moderated ALERT session (Abstracts Leading to Evolution in Respiratory Medicine Trials) held on 8th September, 2020
Details for the live ALERT presentation are as follows:
Presentation Title: Masitinib in severe asthma: Results from a randomized, phase 3 trial
Session Title: Session: ALERT: Asthma in adults and children
Date and time: Tuesday - 8 September at 14:30-15:30 (CEST)
This ALERT abstract will also be presented in the e-poster format on the congress platform and the abstract will be published in a supplement (
The annual
Study AB07015 highlights
Masitinib is a first in class oral drug in severe asthma, selectively targeting mast cells through inhibition of tyrosine kinases c-Kit, LYN and FYN. There is a strong scientific rationale to target mast cells in asthma and study AB07015 was the first positive large-scale study in severe asthma utilizing a drug targeting mast cells [1]. Additionally, masitinib is a potent inhibitor of Platelet-Derived Growth Factor Receptor (PDGFR), which is associated with airway remodeling in asthma [2]. Masitinib is therefore capable of simultaneously modulating independent mechanisms of asthma pathophysiology, which is an attractive therapeutic strategy for severe asthma.
Phase 3 study (AB07105) evaluating oral masitinib at 6 mg/kg/day versus placebo in severe asthma uncontrolled by oral corticosteroids (OCS) met its primary endpoint. Masitinib significantly decreased the rate of severe asthma exacerbations in patients with severe asthma uncontrolled by OCS, regardless of baseline eosinophil level.
Study AB07015 demonstrated efficacy in a difficult to treat population:
- Primary analysis was conducted in the severe asthma population with daily OCS ≥ 7.5 mg and masitinib treatment was associated with a significant reduction in severe asthma exacerbations (-35%, p=0.0103).
- A pre-specified subgroup of severe asthma patients with high eosinophil counts (≥ 150 cells/μL) also demonstrated a statistically significant reduction in rate of severe asthma exacerbations (-38%, p=0.0156).
- Benefit of masitinib was greatest in patients who had higher cumulated use of OCS (indicative of more severe asthma that is harder to control) with statistically significant reduction in rate of severe asthma exacerbations of up to -71% for patients with high eosinophil counts (≥ 150 cells/μL) receiving an annualized cumulative OCS intake of >1000 mg.
Study AB07015 population is distinct from other asthma trials:
- Patients dependent on OCS (100% receiving high dose OCS therapy) and no weaning
- Patients were treated irrespective of baseline eosinophil count
- Evaluated over a long period of time (approx. 60 weeks)
Masitinib has a unique positioning in severe asthma, in terms of administration (oral administration), mechanism of action, targeted population, and broad eosinophil level.
[1] Bradding P, Arthur G. Clin Exp Allergy. 2016 Feb;46(2):194-263.
[2] Kardas G, et al. Front Pharmacol. 2020 Feb 14;11:47.
About masitinib
Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases, and in certain diseases of the central nervous system. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.
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Attachment
- ERS2020 AB07015 ALERT session vEng VF
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