Vyvgart Hytrulo Meets Primary Endpoint in Phase 3 Autoimmune Myositis Trial
KEY TAKEAWAYS
- The phase 3 ALKIVIA clinical trial met its primary endpoint in the combined immune-mediated necrotizing myopathy and dermatomyositis population.
- Vyvgart Hytrulo-treated participants had a 15.4-point greater mean Total Improvement Score improvement at week 52 compared with placebo.
- The treatment effect was statistically significant in immune-mediated necrotizing myopathy; a similar numerical effect was observed in dermatomyositis but did not reach statistical significance.
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc; argenx, Amsterdam, Netherlands) demonstrated statistically significant improvement in adults with autoimmune myositis in topline results from the phase 3 ALKIVIA clinical trial (NCT05523167). The trial evaluated Vyvgart Hytrulo in adults with immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM), 2 autoimmune myositis subtypes.
The study met its primary endpoint in the combined IMNM and DM population, with Vyvgart Hytrulo-treated participants showing a statistically significant and clinically meaningful improvement in mean Total Improvement Score (TIS) at week 52 compared with placebo. Mean TIS was 47.95 with Vyvgart Hytrulo and 32.56 with placebo, representing a 15.4-point treatment difference (P=.0011).
Topline Findings
- In the combined IMNM and DM population, improvements favoring Vyvgart Hytrulo were observed as early as week 4 and sustained through 52 weeks, according to argenx.
- In the prespecified IMNM subgroup, Vyvgart Hytrulo treatment met the week 52 mean TIS endpoint, with a 14.8-point greater improvement versus placebo (45.05 vs 30.24; P=.0048).
- In the DM subgroup, mean TIS numerically favored Vyvgart Hytrulo by 14.5 points (51.51 vs 36.96), although the result was not statistically significant (P=.1093).
- All 6 TIS core set measures contributed to the treatment effect and favored Vyvgart Hytrulo over placebo, including measures related to muscle strength, physical function, and disease activity beyond muscle.
- Improvement in skin disease activity was observed in participants with DM.
Officials at argenx reported that Vyvgart Hytrulo treatment was well tolerated in ALKIVIA and that the safety profile was consistent with prior studies and the known safety profile of efgartigimod. Detailed ALKIVIA data are expected to be presented at a future medical meeting, according to an announcement from the company.
Source
argenx. argenx announces positive topline results from phase 3 ALKIVIA trial of efgartigimod in autoimmune myositis. Published August 17, 2026. Accessed August 20, 2026. https://argenx.com/news/2026/press-release-3345813