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argenx’s VYVGART Hytrulo posts Phase 3 win in ALKIVIA trial
The Phase 3 readout showed a statistically significant 15.4-point Total Improvement Score advantage at Week 52, with the key statistically positive signal coming from the immune-mediated necrotizing myopathy subgroup.
argenx SE reported a clearly positive headline result from its Phase 3 ALKIVIA trial for VYVGART Hytrulo, showing a 15.4-point mean advantage versus placebo on the Total Improvement Score at Week 52 across the combined immune-mediated necrotizing myopathy and dermatomyositis population.
Yahoo Finance reports the difference was statistically significant, with a p-value of 0.0011. In immune-mediated necrotizing myopathy, VYVGART Hytrulo recorded a 14.8-point treatment difference with a p-value of 0.0048, and the outlet notes it is the first therapy to show statistically significant improvement in a Phase 3 trial for IMNM.
The company did not see the same level of statistical support in the smaller dermatomyositis subgroup. Yahoo Finance says that subgroup had a 14.5-point numerical advantage, but it was not statistically significant, raising uncertainty over how that outcome could affect the eventual label and demand for further evidence.
argenx also said improvement appeared by Week 4 and continued through Week 52 even as protocol-directed steroid tapering took place, and that all six score components favored treatment. The outlet added that VYVGART generated $1.516 billion of global product net sales in the second quarter, and it estimates about 40,000 U.S. patients with dermatomyositis versus about 20,000 with IMNM.