Amgen Reports Positive Topline Phase 3 Results for Dazodalibep
核心洞察
Amgen reported positive topline results from the Phase 3 OASIZ 301 study of dazodalibep in adults with Sjögren's disease (搜索) and moderate-to-severe systemic disease activity.
The trial met its primary endpoint with statistically significant and clinically meaningful improvement in ESSDAI score at Week 48, with benefits seen from Week 4.
The most common adverse events were nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions, generally mild to moderate, with no thromboembolic or opportunistic infection imbalance.
Amgen announced positive topline results from the Phase 3 OASIZ 301 study of dazodalibep in adults with Sjögren's disease (搜索) and moderate-to-severe systemic disease activity. The randomized, double-blind, placebo-controlled trial enrolled approximately 621 patients with an ESSDAI of 5 or higher and met its primary endpoint, showing statistically significant and clinically meaningful improvement in systemic disease activity at Week 48 as measured by the EULAR Sjögren's Syndrome Disease Activity Index. Improvements were observed as early as Week 4 and were sustained through Week 48. Key secondary endpoints evaluated dryness, tender and swollen joints, fatigue, and ESSDAI[5] response, defined as a decrease of at least 5 points from baseline.
The most common adverse events, reported at an incidence of 5% or greater and at a higher rate than placebo, were nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions, and were generally mild to moderate. Discontinuations due to adverse events occurred at a low rate and were balanced across treatment groups, and no imbalance in thromboembolic events or opportunistic infections was observed across arms. Amgen plans to present detailed OASIZ 301 data at an upcoming medical meeting. The Phase 3 OASIZ 303 study in moderate-to-severe symptomatic Sjögren's disease (搜索) is expected to complete in Q4 2026, and an open-label long-term extension, OASIZ 304, is also underway.
Dazodalibep is a potential first-in-class CD40L (搜索) antagonist fusion protein designed to target immune activation by disrupting interactions between T cells, B cells and other antigen-presenting cells. Sjögren's disease (搜索) is a heterogeneous systemic autoimmune disease that can cause persistent dryness, fatigue, pain, major organ involvement, neuropathy and an increased risk of lymphoma, and there are currently no FDA-approved medicines for the condition.