New Nipocalimab Data for Myasthenia Gravis

Oral and poster presentations include data from the pivotal Phase III Vivacity-MG3 study of nipocalimab in gMG, which was included in the U.S. Biologics License Application (BLA) for nipocalimab:

1. Data evaluating nipocalimab using the clinician-administered QMG assessment score demonstrated significant improvement in muscle strength. 

2. Results from the ongoing open-label extension (OLE) study evaluating long-term efficacy and safety of nipocalimab show sustained disease control with nipocalimab in a broad population of antibody-positive gMG adult patients. 

Real-world evidence and unmet needs in myasthenia gravis (MG) treatment:

1. Real-world data showcases the unmet needs in treating gMG during pregnancy, and an urgency for further research on treatment options for women with MG who might become pregnant. Nipocalimab continues to be the only investigational treatment with both published data and ongoing Phase III studies in pregnant women at risk of alloantibody conditions of pregnancy, including hemolytic disease of the fetus and newborn (HDFN), and fetal neonatal alloimmune thrombocytopenia (FNAIT).

2. Poster presentations highlight data from two studies examining the association of oral corticosteroid (OCS) exposure in MG, emphasizing the need for additional targeted treatment options with demonstrated safety profiles to minimize the well-known risks of oral corticosteroids. 

3. Findings from a real-world study of MG serostatus testing show variation in MG antibody testing in current clinical practice, uncovering infrequent MuSK and LRP4 testing among antibody negative patients. The study found a socioeconomic correlation to lack of further diagnostic testing which highlights an opportunity in care and can inform more targeted treatment plans.

Patient-reported data & disease burden: 

A poster presentation will showcase patient-reported insights on factors contributing to MG exacerbations and symptom worsening: Findings suggest that many individuals currently living with MG in the U.S. reported uncontrolled disease. Important risk factors identified for exacerbation or symptom worsening included living alone, generalized MG symptomology, and comorbid anxiety/depression. These findings underscore the ongoing need for additional approved immunoselective therapies that are effective with demonstrated safety profiles for people living with gMG.

“We’re excited to share our latest research in gMG, reinforcing our commitment to advancing innovation in the autoantibody disease space. These presentations highlight our dedication to helping address critical unmet needs and improving outcomes for a broad population of patients through our pathway-based approach to research and development”, said Katie Abouzahr, M.D., Vice President, Autoantibody and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. “We look forward to engaging with the medical and patient community at AAN and continuing important scientific exchange that drive progress in patient care.”

The Phase III Vivacity-MG3 study (NCT04951622) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial. 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. Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo). The primary endpoint of the study was mean change in MG-ADL^b score from baseline over Weeks 22, 23 and 24 in antibody positive patients. A key secondary endpoint included change in QMG score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.