Argenx's Vyvgart Meets Primary Goal In Late-Stage Bleeding Disorder Study

  • Argenx SE's ARGX Phase 3 ADVANCE trial of Vyvgart (efgartigimod alfa-fcab) in adults with primary immune thrombocytopenia (ITP) met its primary endpoint
  • The ADVANCE trial enrolled 131 adult patients with chronic and persistent ITP. Patients were heavily pretreated.
  • A higher proportion of patients with chronic ITP receiving VYVGART (17/78; 21.8%) than placebo (2/40; 5%) achieved a sustained platelet response.
  • Vyvgart-treated patients had a statistically significant benefit compared to placebo on a cumulative number of weeks where platelet counts were at least 50x109/L and sustained platelet response in the overall population.
  • Numerically fewer WHO-classified bleeding events occurred in treated patients throughout the trial, but the difference from placebo was not statistically significant. 
  • Ten Vyvgart-treated patients switched to a biweekly dosing schedule after achieving platelet counts of 100x109/L for three out of four consecutive visits, compared to one placebo patient. 
  • Nine of the ten treated patients achieved a sustained platelet response.
  • Vyvgart was well-tolerated, and the observed safety and tolerability profile were consistent with previous clinical trials.
  • The Phase 3 ADVANCE trial is the first of two registrational trials being conducted as part of the ongoing ITP development program. 
  • ADVANCE-SC is evaluating subcutaneous efgartigimod for the treatment of primary ITP. Topline data are expected in Q1 of 2023.
  • Price Action: ARGX shares are up 9.53% at $320.84 during the market session on the last check Thursday.
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