Pharma Update
Astegolimab: Pivotal program results expected in 2025
Two pivotal trials ARNASA and ALIENTO with similar design currently ongoing
Pllb (ALIENTO) / Ph III (ARNASA) trial design
Roche
Population
Astegolimab SC Q2W
Former & current smokers, EOS low to high
Screening
(n=1290)
R
Astegolimab SC Q4W
1:1:1
Endpoints
Primary: AERR at 52 weeks
Secondary: SGRQ, FEV₁, E-RS, annualized
rate of severe COPD exacerbation
Weeks
0
Placebo
+
52
• Pivotal program includes up-scaled Ph llb (ALIENTO) and Ph III (ARNASA); results expected in 2025
Primary endpoint of change in AER at 52 weeks, with secondary endpoints focused on disease/ health status (e.g. change in FEV₁/SGRQ)
•
Broad patient population including former and current smokers, and EOS low to high
•
Filing expected to be based on combined ARNASA and ALIENTO results
• OLE for ALIENTO and ARNASA was initiated in H1 2023
Follow-up
COPD-chronic obstructive pulmonary disease; R=randomization; SC=subcutaneous; Q2W/Q4W-every 2/4 weeks; EOS-eosinophils; AER(R)-annualized exacerbation rate (reduction); SGRQ-St. George's respiratory questionnaire;
FEV₁-forced expiratory value; E-RS-evaluating respiratory systems; OLE=open label extension
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