Phase III Vivacity-MG3 Trial Demonstrates Superiority of Nipocalimab Over Placebo in Treating Patients with Generalized Myasthenia Gravis

Image Credit: Adobe Stock Images/Lila Patel

Results from the Phase III Vivacity-MG3 trial show that Johnson & Johnson’s (J&J) nipocalimab in combination with standard-of-care (SOC) achieved superiority over placebo plus SOC when treating patients with generalized myasthenia gravis (gMG), as measured by the primary endpoint of improvement in the MG-ADL score from baseline over 24 weeks. According to the company, this marks the first time that an FcRn blocker to demonstrate superiority in activities of daily living (MG-ADLa) over placebo when added to standard of care over 24 weeks in antibody positive patients.¹

"The sustained response of nipocalimab over six months among this broad myasthenia gravis population is an important finding given the chronic, unpredictable exacerbations typically seen with myasthenia gravis," said Carlo Antozzi, MD, neuroimmunology and muscle pathology unit, Neurological Institute Foundation C. Besta, Milan, Italy, in a press release. "We are encouraged by the potential of nipocalimab to uniquely help address this gap for people living with myasthenia gravis."

Vivacity-MG3 is a double-blind placebo-controlled study that consists of 199 anti-AChR+, anti-MuSK+ and/or anti-LRP4+ patients, 153 of which were antibody positive. According to the study, randomization was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC. The primary endpoint of the study was mean change in MG-ADLa score from baseline over Weeks 22, 23 and 24 in antibody positive patients, with the secondary endpoint being a change in muscle strength and function (QMGc) score.

Results found that patients nipocalimab plus SOC showed a 4.70-point improvement in MG-ADL scores, considerably higher than the 3.25-point improvement observed with placebo plus SOC (P=0.002). Additionally, QMG improved significantly over weeks 22 and 24 (P<0.001), and a greater MG-ADL response (≥2-point improvement) with nipocalimab plus SOC (P=0.021).

Safety and tolerability of the study was reported to be consistent with previous studies of nipocalimab. The incidence of adverse events (AEs) serious adverse events and adverse events leading to discontinuation was similar to that in the placebo plus current SOC group.¹

While there is currently no cure for gMG, there are a number of medications to help treat it, such as cholinesterase inhibitors, corticosteroids, immunosuppressants, intravenous therapy, and surgery.²

“Various treatments, alone or together, can help with symptoms of myasthenia gravis, reports the Mayo Clinic. “Your treatment will depend on your age; how severe your disease is and how fast it's progressing.”

In order to determine if a patient has gMG, health care providers could check neurological health through testing reflexes, muscle strength, muscle tone, sense of touch and site, coordination, and balance. Additionl tests include ice pack tests, blood analyses, repetitive nerve stimulation, single-fiber electromyography, imaging, and pulmonary function tests.

The Mayo Clinic also suggests that adjustments should be made at home in order to cope with a gMG diagnosis. This includes adjusting eating routines, enhanced safety precautions at home, and use electric appliances to save energy.²

Moving forward, the data is expected to be presented later this year among eight abstracts at the European Academy of Neurology (EAN) 2024 Congress and will also be submitted for approval to regulatory authorities.¹

"We are thrilled to present yet another dataset for nipocalimab at the EAN 2024 Annual Meeting highlighting our commitment to providing innovative treatments for autoantibody-driven diseases," said Katie Abouzahr, MD, VP, autoantibody and maternal fetal immunology disease area leader, Johnson & Johnson Innovative Medicine, in the press release. "We are developing transformative therapies that have the potential to address significant unmet patient need."

References

1. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class for broadest population of myasthenia gravis patients. PR Newswire. June 28, 2024. Accessed July 1, 2024. https://www.prnewswire.com/news-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class-for-broadest-population-of-myasthenia-gravis-patients-302185879.html

2. Myasthenia gravis. Mayo Clinic. Accessed July 1, 2024. https://www.mayoclinic.org/diseases-conditions/myasthenia-gravis/diagnosis-treatment/drc-20352040