Respiratory - September 2020

Respiratory - September 2020

Dupixent (dupilumab) long-term data show sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe Asthma

08 Sep 2020

Dupixent (Dupilumab, Anti-IL-4Rα mAb) – Sanofi/Regeneron

  • New long-term data from the Phase 3 LIBERTY ASTHMA TRAVERSE open-label extension trial showed sustained improvement in lung function and reduction in severe exacerbations in both adults and adolescents with moderate-to-severe Asthma
  • Dupixent is the first and only biologic to demonstrate such sustained improvements in lung function and Asthma exacerbations across a broad patient population with type 2 inflammation
  • Results:
    • Efficacy:
      • Lung function: At 96 weeks, 13-22% of patients continued to experience improvement in lung function as measured by the average change in FEV1 compared to baseline
      • Asthma attacks: Patients maintained a low rate of severe Asthma attacks with an average of 0.31-0.35 events/year
      • Type 2 inflammation: Reductions in blood eosinophils: 23-35%; Blood IgE (patients from the pivotal Phase 2b trial): 82%
    • Safety:
      • The proportion of patients with AEs in the open label extension trial was similar to that seen in prior pivotal trials of Dupixent in Asthma
      • Overall AE rates (96-week treatment period): 76-88%
      • Most common AEs: nasopharyngitis (18-26%) and injection-site erythema (2-23%)
      • Overall SAEs: 9-13% patients
  • Additional long-term efficacy data in OCS-dependent patients will be presented at a later congress

Sanofi’s Dupixent continued to show positive outcomes in long-term Phase 3 trial

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CI Scientists Remarks: 

  • Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins
  • Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in Asthma, Chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis
  • Phase 3, multicenter, open-label extension trial evaluated long-term safety and efficacy of Dupixent treatment in 2,282 adults and adolescents with moderate-to-severe Asthma who had previously participated in a controlled Dupixent clinical trial, including the pivotal Phase 2b DRI (24 weeks) and Phase 3 QUEST (52 weeks) trials in patients with moderate-to-severe Asthma and the Phase 3 VENTURE (24 weeks) trial in patients with severe oral corticosteroid (OCS)-dependent Asthma
  • Patients in the open-label extension trial received 300 mg Dupixent every other week for up to 96 weeks in addition to standard-of-care maintenance therapies
  • Dupixent approvals:

Region

Patient segments

EU

Adults and adolescents 12 years and older as an add-on maintenance treatment for severe Asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, who are inadequately controlled with high dose inhaled corticosteroid (ICS)

US

In combination with other Asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent Asthma in patients aged 12 years and older whose Asthma is not controlled with their current Asthma medicines

Japan and other countries

patients aged ≥ 12 years with severe or refractory Asthma whose symptoms are inadequately controlled with existing therapies

  • In addition to the currently approved indications, Sanofi/Regeneron are also studying Dupixent in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammations

Indication

Stage of development

Pediatric Asthma (6 to 11 years of age)

Phase 3

Pediatric atopic dermatitis (6 months to 5 years of age)

Phase 3

Eosinophilic esophagitis

Phase 3

Chronic obstructive pulmonary disease

Phase 3

Bullous pemphigoid

Phase 3

Prurigo nodularis

Phase 3

Chronic spontaneous urticaria

Phase 3

Food and environmental allergies

Phase 2

  • In Q2’20, US sales of Dupixent grew 69.5% to €697 million and global sales grew by 70% to €858 million driven by growth in atopic dermatitis, strong uptake in Asthma and launch in Chronic rhinosinusitis with nasal polyps (CRSwNP)

– Dr. Kowndinya, CI Scientists

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