Long-term Safety and Efficacy of Nipocalimab in Generalized Myasthenia Gravis: Vivacity-MG3 Open-label Extension Phase Results
Carlo Antozzi1, Tuan Vu2, Sindhu Ramchandren3, Richard Nowak4, Constantine Farmakidis5, Vera Bril6, Jan De Bleecker7, Huan Yang8, Eduard Minks9, Jin-Sung Park10, Mariusz Grudniak11, Marek Smilowski12, Teresa Sevilla13, Sarah Hoffmann14, Kumaraswamy Sivakumar15, Eriene Wassef3, Panna Sanga3, Keith Karcher3, Yaowei Zhu3, John Sheehan3, Hong Sun3
1Neurology IV - Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto; Neurologico Carlo Besta, Milan, Italy, 2Neurology, University of South Florida, Tampa, FL, USA, 3Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA, 4Department of Neurology, Yale University School of Medicine, New Haven, CT, USA, 5Neurology, University of Kansas Medical Center, Kansas City, KS, USA, 6Neurology, University of Toronto, University Health Network, Toronto, Canada, 7Neurology, Ghent University Hospital, Ghent, Belgium, 8Neurology, Xiangya Hospital, Central South University, Changsha, China, 9First Department of Neurology, Faculty of Medicine, Masaryk University and St. Anne’s Hospital, Brno, Czech Republic, 10Department of Neurology, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, South Korea, 11Neurology, Centrum Medyczne Neuro-Protect Ul, Warszawa, Poland, 12Neurology, Silesian Neurology Medical Center, Katowice, Poland, 13Neurology, Hospital Universitari i Politècnic and IIS La Fe/University of Valencia, Valencia, Spain, 14Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany, 15The Neuromuscular Research Center and Neuromuscular Clinic of Arizona, Phoenix, AZ, USA
Objective:
To assess the long-term safety and efficacy of nipocalimab, a novel FcRn blocker, in patients with generalized myasthenia gravis (gMG) from the Vivacity-MG3 (NCT04951622) open-label extension (OLE) phase.
Background:
There is an unmet need for gMG treatments that are safe and provide sustained symptom control for patients. In autoantibody-positive patients with gMG, nipocalimab demonstrated significant improvement from baseline over weeks 22, 23, and 24 with mean (SE) change in MG-ADL score of –4.70 (0.329) vs. placebo (least square [LS] mean difference –1.45; p=0.002) in the phase 3 Vivacity-MG3 study.
Design/Methods:
Autoantibody-positive (n=153, anti-acetylcholine receptor [AChR]/muscle-specific tyrosine kinase [MuSK]/low-density lipoprotein receptor [LRP4] positive) and triple-autoantibody-negative patients (n=43) with gMG (Myasthenia Gravis Foundation of America [MGFA] Class II-IV), inadequately controlled (MG-Activities of Daily Living [MG-ADL] >6) on standard-of-care (SOC) therapy, were randomized 1:1 to nipocalimab+SOC or placebo+SOC in a 24-week double-blind study, with the option to enter an ongoing OLE phase. Safety was assessed in patients receiving ≥1 dose of study drug.
Results:
A total of 137 autoantibody-positive patients from the double-blind phase enrolled in the OLE and received nipocalimab+SOC. The mean (SE) change in MG-ADL from the double-blind baseline was –5.73 (0.401) [n=81] at OLE week 24, and –5.97 (0.681) [n=37] at OLE week 48. Nipocalimab was generally well-tolerated and there were no new safety findings in the OLE phase. Updated results of this ongoing study will be presented.
Conclusions:
The FcRn blocker nipocalimab demonstrated sustained disease control over 72 weeks across double-blind and open-label phases, as assessed using the MG-ADL scale, in a broad population of autoantibody-positive patients with gMG in the phase 3 Vivacity-MG3 study.
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