AstraZeneca reported positive Phase III results for its experimental COPD biologic tozorakimab and received U.S. accelerated approval for Etcamah, or camizestrant, in a defined group of patients with advanced hormone receptor-positive breast cancer.
Results from the Phase III OBERON and TITANIA studies showed tozorakimab reduced moderate and severe chronic obstructive pulmonary disease exacerbations versus placebo in patients continuing inhaled standard therapy. The trials included 2,306 current and former smokers with symptomatic COPD and a history of frequent exacerbations.
Patients received tozorakimab 300 milligrams every four weeks or placebo for 52 weeks. Among former smokers, the drug reduced moderate and severe exacerbations by 29% in OBERON and 34% in TITANIA. In the overall population of current and former smokers, reductions were 30% and 29%, respectively.
A pooled analysis found reductions across blood eosinophil subgroups. Patients with counts below 150 had a 23% reduction in exacerbations, while reductions were 34% for those with counts of at least 150 and 43% for those with counts of at least 300.
Tozorakimab was generally well tolerated, AstraZeneca said, with injection-site reactions the only adverse drug reaction reported. The company’s U.S. biologics license application is under Priority Review, with a decision anticipated in the first quarter of 2027. The treatment is also under review in the European Union and China.
Separately, the FDA approved Etcamah with a CDK4/6 inhibitor for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer whose tumors develop an ESR1 mutation during first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor.
The approval was based on the Phase III SERENA-6 study of 315 patients. Etcamah plus a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% versus continued aromatase inhibitor therapy plus a CDK4/6 inhibitor. Median progression-free survival was 16.0 months, compared with 9.2 months.
The FDA also approved a companion diagnostic blood test to detect ESR1 resistance mutations in circulating tumor DNA. The trial used testing at routine scans to identify mutations before clinical or radiographic disease progression and switch patients’ endocrine therapy.
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