Post-hoc evaluation of the clinical effects of nipocalimab, a new neonatal fragment crystallizable blocker, over time in the Vivacity MG3 study

Topic:

Clinical Trials

Poster Number: P359

Author(s):

Maria Ait-Tihyaty, PhD, Johnson & Johnson, Titusville, NJ, USA, Richard Nowak, MD, MS, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA, Ibrahim Turkoz, Johnson & Johnson, Titusville, NJ, USA, Kavita Gandhi, Johnson & Johnson, Raritan, NJ, USA, Rachelle Rodriguez, Johnson & Johnson, Raritan, NJ, USA, Sarah Gingerich, Johnson & Johnson, Ontario, Canada, Sheryl Pease, Johnson & Johnson, Raritan, NJ, USA, Hans Katzberg, University of Toronto, Toronto, Ontario, Canada

BACKGROUND: In generalized myasthenia gravis (gMG), there remains an unmet need for treatments providing meaningful symptom control. Nipocalimab, a neonatal fragment crystallizable receptor (FcRn) blocker, has demonstrated positive results in a 24-week double-blind Phase 3 study with a rapid, substantial, and sustained efficacy.

OBJECTIVE: To conduct a post-hoc evaluation of the clinical effects of nipocalimab over time in the Vivacity MG3 study.
METHODS: Mean changes in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) were compared between nipocalimab+standard-of-care (SOC) and placebo+SOC. The proportion of patients achieving Minimal Symptom Expression (MSE), MG-ADL total score 0/1, and percentage of time with MSE and the proportion of patients with sustained within person meaningful change (WPMC) [≥2-point improvement], starting from Week 4 and percentage of time spent with WPMC were compared between treatment groups.

RESULTS: Nipocalimab+SOC demonstrated statistically significant improvement in MG-ADL (over weeks 22, 23, and 24) vs placebo+SOC, LS-mean change [SE] −4.7 [0.329] vs −3.25 [0.335]; difference in means [SE]= −1.45 [0.470], p=0.002). The mean difference, in favor of nipocalimab+SOC, was significant as early as Week 1: LS mean change [SE]: −2.72 [2.979] vs −1.77 [2.426]; difference in means [SE] −0.82 [0.410], p=0.046. Nipocalimab+SOC patients were three times more likely to achieve MSE at any point during the study vs placebo+SOC; odds ratio [95% CI]: 3.0 [1.3, 6.8]; 31.2% vs. 13.2%. For the 25 patients (18, nipocalimab+SOC; 7, placebo+SOC) reaching MSE, the time sustaining MSE [percent time with MSE] was 101.5 days, (60.4%, nipocalimab+SOC) vs 55 days, (32.7%, placebo+SOC). Similarly, the proportion of patients with sustained WPMC favored nipocalimab+SOC, 55.8% vs 26.3%, placebo+SOC, p<0.001. The median percent time spent with WPMC was 84.5%, nipocalimab+SOC vs 39.9%, placebo+SOC, p=0.007. CONCLUSION: Based on MG-ADL data from a Phase 3 study, nipocalimab, a new FcRn blocker, demonstrated rapid, substantial, and sustained symptom control. © 2024 MGFA Scientific Session at AANEM