Amgen reports positive Phase 3 results for dazodalibep in Sjögren’s disease

Phase 3 results

In the 648-patient, placebo-controlled OASIZ-301 study, both dazodalibep regimens significantly reduced systemic disease activity at Week 48, meeting the primary endpoint measured by the ESSDAI. Scores fell by 5.6 points with 1,500 mg every four weeks and 5.2 points with 3,000 mg every 12 weeks, compared with 3.8 points with placebo. Treatment effects were observed from Week 4 and sustained through Week 48.

The 1,500 mg every-four-weeks regimen also significantly improved patient-reported dryness versus placebo, with placebo-adjusted differences of −1.17 points on the ESSPRI dryness domain and −0.93 points on the DASPRI dryness domain. Additional analyses reported improvements in total symptom scores, systemic disease activity domains, stimulated salivary flow and STAR response rates.

Safety and development

Common adverse events reported more frequently with dazodalibep than placebo included nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions; these were generally mild to moderate. Serious adverse events and discontinuations were balanced across groups. No imbalance was observed in thromboembolic events or opportunistic infections, and malignancy rates were low and comparable.

Dazodalibep is a potential CD40L antagonist fusion protein. Amgen is also conducting OASIZ-303, a Phase 3 study in patients with high symptom burden and low systemic disease activity, and OASIZ-304, a long-term extension study.