J&J positions nipocalimab to rival Vyvgart after hitting mark in myasthenia gravis trial

2024-06-28

临床结果临床3期上市批准临床2期生物类似药

Johnson & Johnson unveiled more details from a Phase III study of nipocalimab in generalised myasthenia gravis (gMG), adding another feather to its cap for the FcRn inhibitor FcRn inhibitor programme. In addition to bolstering nipocalimab's potential in gMG, the results may also set the stage for a showdown with argenx's rival FcRn blocker Vyvgart (efgartigimod alfa), which was approved in 2021 for gMG patients who are positive for anti-AChR antibodies.

Data from the VIVACITY-MG3 study, presented Friday at the European Academy of Neurology (EAN) conference, demonstrated superiority of nipocalimab over placebo in improving activities of daily living.

The trial enrolled 199 adults with gMG, including 153 who were antibody-positive. Participants received either nipocalimab or placebo, both in addition to standard of care. Efficacy results showed that nipocalimab-treated patients achieved a 4.70-point improvement from baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score over weeks 22, 23, and 24, compared to a 3.25-point improvement seen with placebo. The gap was statistically significant.

"For someone living with gMG, a one- to two-point change on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator," the company said in its release.

Key secondary endpoints were also met, including improvements in muscle strength and function as measured by the Quantitative Myasthenia Gravis (QMG) score over weeks 22 and 24. Further, a significantly greater proportion of nipocalimab-treated patients experienced ≥2-point improvement from baseline in MG-ADL response.

Safety data were consistent with previous nipocalimab studies, with similar rates of serious adverse events and discontinuations between the nipocalimab and placebo groups.

'Sizeable opportunity'

J&J, which acquired the anti-FcRn antibody through its $6.5-billion takeout of Momenta Pharmaceuticals back in 2020, plans to submit regulatory filings for nipocalimab in gMG later this year, potentially setting up a competitive challenge to Vyvgart. Argenx's product generated $1.2 billion in 2023 sales.

However, J&J aims to differentiate nipocalimab by highlighting its efficacy across a broader range of antibody-positive gMG patients, including those with anti-MuSK and anti-LRP4 antibodies, in addition to the more common anti-AChR antibodies. A recent Morgan Stanley note cited one key opinion leader (KOL) as seeing a "sizable opportunity" for nipocalimab in gMG, potentially as a second-line option for patients with incomplete response to Vyvgart. The KOL estimated that about 50% of Vyvgart patients could fit that portrait.

The gMG success adds to nipocalimab's growing portfolio of positive clinical data across autoimmune indications. Earlier this month, J&J reported that nipocalimab had met its primary endpoint in a Phase II trial for Sjögren's disease. The drug has also shown promise in rare maternal-foetal disorders.

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