tozorakimab - (TITANIA)

September 5-9, 2026: AstraZeneca (NYSE: AZN) reported full Phase III OBERON and TITANIA results for tozorakimab in symptomatic COPD patients with a history of exacerbations, presented at the European Respiratory Society Congress 2026 and published in the New England Journal of Medicine. In the primary population of former smokers, tozorakimab 300 mg every four weeks reduced annualized moderate/severe exacerbations by 29% in OBERON (RR 0.71, 95% CI 0.57-0.88) and 34% in TITANIA (RR 0.66, 0.55-0.80) versus placebo on top of inhaled standard of care. In the overall population of current and former smokers, reductions were 30% in OBERON (RR 0.70, 0.58-0.85) and 29% in TITANIA (RR 0.71, 0.59-0.84).

Pooled subgroup analysis showed reductions across blood eosinophil counts: 23% for <150 cells/uL, 34% for >=150, and 43% for >=300. A separate ERS poster reported reduced mucus plug score in an integrated OBERON/TITANIA analysis. Tozorakimab was generally well tolerated; the only adverse drug reaction reported was injection-site reaction.

A Biologics License Application for add-on maintenance treatment in adult COPD has been accepted by the FDA under Priority Review, with a PDUFA date anticipated in Q1 2027. Regulatory review is also ongoing in the EU and China.