Depemokimab - not approved by TGA in HES.MCAB against IL-5



"The Investigator must seek the Sponsor's written approval to publish or otherwise disclose information.".  The decision for publication must be that of the investigators.
HREA M2.7: "Biospecimens will be destroyed. Biospecimens will be retained for future use." - needs clarification
M6.1.1.1.9: side effects. Nasopharyngitis is not common cold. Is incidence same as healthy population?
Worsening of asthma
Q3.11.1 "The global sponsor will take all reasonable measures to keep personal health information confidential however absolute confidentiality cannot be guaranteed"
Sample size of 120 (80 + 20) - flare rate of 1.46 vs 0.4 - 95% power to detect stat significance
No allowance for dropouts


M Cook no longer at ANU/TCH
Why not do non-inferiority study?
Mepolizumab = existing anti-IL-5 MCAB - efficacious & well-tolerate. Approved in a number of countries (not Aus). Not considered standard of care
AEs: anaphylaxis, immune complex dis (monkeys, not shown in humans), anti-drug Abs, QTc prolongation (monkeys only)
Primary endpoint = frequency of flares over 12/12 (need 2/yr for entry)
Investigator won't see eosinophil counts (drop rapidly with Rx) - may be difficult to blind adequately