Zai Lab and argenx Announce Positive Topline Results from Phase 3 ALKIVIA Trial of Efgartigimod in Autoimmune Myositis
Zai Lab and partner argenx reported positive topline results from the Phase 3 ALKIVIA trial of VYVGART Hytrulo for autoimmune myositis, meeting the primary endpoint of Total Improvement Score (TIS) at Week 52 in the combined IMNM and DM population (p=0.0011). Patients treated with efgartigimod showed a 15.4 point greater improvement in TIS versus placebo, with benefits sustained through 52 weeks. The study also met statistical significance in the IMNM subtype (p=0.0048), marking the first Phase 3 program to demonstrate efficacy in this indication which currently has no approved therapies.
Key figures
- Drug Name
- VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
- Phase Of Trial
- Phase 3
- P value dm
- 0.1093
- Tis drug dm
- 51.51
- P value imnm
- 0.0048
- Tis drug imnm
- 45.05
- Tis placebo dm
- 36.96
- P value combined
- 0.0011
- Tis placebo imnm
- 30.24
- Tis drug combined
- 47.95
- Tis improvement dm
- 14.5
- Tis improvement imnm
- 14.8
- Tis placebo combined
- 32.56
- Tis improvement combined
- 15.4
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.