Fixed-dose treatment with nipocalimab, an investigational neonatal Fc receptor blocker, lessened disease severity in generalized myasthenia gravis, according to pivotal phase III data presented at the American Association of Neuromuscular and Electrodiagnostic Medicine annual meeting.
In this exclusive MedPage Today video, investigator Tuan Vu, MD, of the University of South Florida in Tampa, discusses the study design and importance of the Vivacity-MG3 trial.
Following is a transcript of his remarks:
My name is Tuan Vu. I'm a professor of neurology at the University of South Florida in Tampa. I was a participant in the nipocalimab study looking at this medication in the treatment of patients with generalized myasthenia gravis.
The study is designed a little bit different[ly] than the two other medications in this class that were approved by the FDA for the treatment of myasthenia gravis [rozanolixizumab (Rystiggo) and efgartigimod (Vyvgart)]. The other two medications use an on-demand, cyclical administration schedule, whereas this study uses a fixed every-2-weeks, infusion cycle treatment. And for the cyclical treatment, there's variation in symptom control; it depends on where you are. Whereas a fixed cycle allows you to have a more steady control of the symptoms over time. So that's the major difference in this medication versus the two available.
This [study] also looked at patients with MuSK antibodies and also with LRP4 antibodies. And as a group, the response seemed to be positive, or more so positive in the patients treated with nipocalimab versus placebo. And at the 24-week endpoint measurement, there was a statistically significant difference between the two groups.
The important thing is to see how durable the effect is and what the long-term safety signals would be. And of course, this trial has that open-label extension for the next several years, I think, so that way we can get more data on this aspect of the treatment.
It is the third medication in this class to show effects and also gives us some more signals in terms of safety for the whole group for the whole class. And I think it's encouraging and it's certainly one more thing that we can use in the treatment of MG.
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Disclosures
This study was supported by Janssen.
Vu reported being a consultant or on speaker bureaus for Alexion/AstraZeneca Rare Disease, Amgen, argenx, CSL Behring, Dianthus, ImmunAbs, Johnson & Johnson, and Takeda. He also had research or grant support related to myasthenia gravis from Alexion/AstraZeneca Rare Disease, Amgen, argenx, Cartesians, COUR, Dianthus, Immunovant, Johnson & Johnson, NMD Pharma, Regeneron, and UCB.
Primary Source
American Association of Neuromuscular and Electrodiagnostic Medicine
Vu T, et al "Efficacy and safety of nipocalimab in patients with generalized myasthenia gravis: Top line results from the double-blind, placebo-controlled, randomized phase 3 VIVACITY-MG3 study" AANEM 2024.