Argenx: Vyvgart Hytrulo meets primary endpoint in Phase 3 ALKIVIA myositis trial
In the Phase 3 ALKIVIA trial, efgartigimod improved the Total Improvement Score by 15.4 points over placebo at 52 weeks; the result was significant in IMNM but not in dermatomyositis.
Argenx reported that the Phase 3 ALKIVIA trial of Vyvgart Hytrulo in autoimmune myositis met its primary endpoint, according to ad-hoc-news.de. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗ In the combined population of immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM), patients treated with efgartigimod improved by 15.4 points more than those on placebo on the Total Improvement Score after 52 weeks (p=0.0011). Key secondary endpoints were also met: response rate, time to response, muscle strength and disease activity.
The safety profile was consistent with earlier studies. The trial included 265 randomized patients, and 175 were treated in the Phase 3 stage.
Results by subgroup
Analyzed separately, the two conditions differ. In IMNM, the advantage over placebo was 14.8 points and statistically significant (p=0.0048). Creatine kinase, a marker of muscle damage, fell by 43.5 percentage points more than in the placebo group.
In dermatomyositis, the gap to placebo was similar at 14.5 points, but the group did not reach statistical significance (p=0.1093). ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗ The company points to the smaller cohort and to improvements in muscle strength and skin findings that appeared from week 4. The result is therefore mixed: clear in IMNM, unresolved in DM.
Regulatory plans and next data
Argenx intends to focus on IMNM for now while continuing development in DM. In the USA, about 20,000 patients are diagnosed with IMNM and about 40,000 with DM. The article notes that no approved therapy exists for the subgroup where the data are most pronounced.
The company plans to submit a supplemental biologics license application (sBLA) for IMNM to the US FDA by the end of 2026. An existing special FDA designation for the program supports the filing.
Full data will be presented on 11 November in a late-breaking talk at the ACR Convergence rheumatology congress. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗ Details on subgroups and tolerability are expected there.
