Abstract Details

Title Efficacy of Nipocalimab, a Novel Neonatal Fragment Crystallizable Receptor Blocker, as Measured Using Quantitative Myasthenia Gravis Assessment: Findings from the Phase 3 Placebo-controlled Vivacity-MG3 Study

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) S34 - Updates on Myasthenia Gravis (1:00 PM-1:12 PM)

Poster/Presentation
Number 001

Background There remains an unmet need for effective treatments providing meaningful symptom control in gMG. Patients treated with nipocalimab+standard-of-care (SoC) achieved significant improvement in mean MG-Activities of Daily Living score from baseline over weeks 22 to 24 compared with placebo+SoC in the 24-week double-blind, phase-3 Vivacity-MG3 study (NCT04951622).

Objective To assess efficacy of nipocalimab using Quantitative Myasthenia Gravis (QMG) in patients with generalized myasthenia gravis (gMG).

Design/Methods Mean changes in QMG total score were compared between nipocalimab+SoC (nipocalimab) and placebo+SoC (placebo). A negative change in score indicates improvement. The proportion of patients achieving improvement of QMG ≥3 points (QMG-3), and sustaining QMG-3 improvement, and the proportion of time spent with QMG-3 improvement were examined for nipocalimab and placebo groups.

Results Nipocalimab demonstrated statistically significant improvement in QMG total score vs placebo over weeks 22 and 24; least-square (LS) mean change (SE): –4.9(0.50) vs –2.0(0.50); difference= –2.81(0.710); p<.001. Mean differences between groups was observed as early as the first post-baseline assessment (week 2): LS-mean change (SE): –3.6(0.36) vs –0.6(0.355); difference of –3.1(0.51); p<.001 favored nipocalimab. Earliest week (mean [SD]) QMG-3 improvements were 3.8(3.88) for nipocalimab vs 7.5(6.33) weeks for placebo. Within 8 weeks of treatment initiation, 89 (nipocalimab:71.4%[55/77]; placebo:44.7%[34/76]) patients achieved QMG-3 improvement; p<.001. Of 63 patients with sustained QMG-3 improvement for ≥8 weeks, significantly greater proportion were from the nipocalimab (55.8%[43/77] vs 26.3%[20/76]; p<.001) placebo group. Patients receiving nipocalimab were over four times more likely to sustain QMG-3 improvement for ≥16 weeks (Odds Ratio [95%CI]: 4.31[1.93, 9.66]) and for ≥20 weeks (Odds Ratio [95%CI]: 4.53[1.93, 10.62]). Significantly more patients from nipocalimab vs placebo (36.4% vs 10.5%; p<0.001) group spent >75% of study duration with QMG-3 improvement.

Conclusions These results indicate that nipocalimab, a novel FcRn blocker, demonstrated disease control in patients with gMG, as evidenced by significant improvements in QMG scores.

Authors/Disclosures
Richard J. Nowak, MD (Yale University School of Medicine) PRESENTER	Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion . Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for argenx. Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Nowak has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunovant . Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cabaletta Bio . Dr. Nowak has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cour Pharma. Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Nowak has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janseen . The institution of Dr. Nowak has received research support from UCB. The institution of Dr. Nowak has received research support from Alexion . The institution of Dr. Nowak has received research support from Janseen. The institution of Dr. Nowak has received research support from Immunovant . The institution of Dr. Nowak has received research support from argenx. The institution of Dr. Nowak has received research support from Amgen. Dr. Nowak has a non-compensated relationship as a Member of the Board of Directors with Myasthenia Gravis Foundation of America (MGFA) that is relevant to AAN interests or activities.
Sindhu Ramchandren	No disclosure on file
Maria Ait Tihyaty (Johnson and Johnson Innovative Medicine)	Dr. Ait Tihyaty has received personal compensation for serving as an employee of Johnson and Johnson.
Ibrahim Turkoz (Janssen R&D)	Ibrahim Turkoz has received personal compensation for serving as an employee of Johnson and Johnson. Ibrahim Turkoz has stock in Johnson and Johnson.
Kavita Gandhi, MS, BSPharm	Ms. Gandhi has received personal compensation for serving as an employee of Johnson and Johnson . Ms. Gandhi has stock in Johnson and Johnson .

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