Long-term Safety and Efficacy of Nipocalimab: Approximately Two Years Follow-up Results From the Open-label Extension Phase of Vivacity-MG3 Study
Carlo Antozzi1, Tuan Vu2, Sindhu Ramchandren3, Richard J. 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, Panna Sanga3, Ibrahim Turkoz3, Yaowei Zhu3, Marie Fitzgibbon16, Michel Burcklen17
1Immunotherapy and Apheresis Unit, Neuroimmunology and Muscle Pathology Unit, Fondazione IRCCS Istituto Neurologico C. Besta, Milan, Italy, 2Neurology, University of South Florida, Tampa, FL, USA, 3Johnson & Johnson, 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, 16Johnson & Johnson, Raritan, NJ, USA, 17Johnson & Johnson, Basel, Switzerland
Objective:
To assess the long-term safety and efficacy of nipocalimab in patients with generalized myasthenia gravis (gMG) from the ongoing Vivacity-MG3 (NCT04951622) open-label extension (OLE) phase.
Background:
In patients with gMG, long-term sustained symptom control remains an important treatment goal. In a broad population of autoantibody-positive patients with gMG, nipocalimab (neonatal Fc-receptor blocker), has demonstrated substantial improvement from baseline in MG-Activities of Daily Living (MG-ADL) scores over 24 weeks (W) in double-blind (DB) phase and over 60W of OLE phase of Vivacity-MG3 study. Results with additional follow-up are presented up to Week 96 of OLE of nipocalimab treatment.
Design/Methods:
In Vivacity-MG3, adult patients with gMG (Myasthenia Gravis Foundation of America Class II-IV), inadequately controlled (MG-ADL≥6) on standard-of-care (SOC) therapy, were randomized 1:1 to nipocalimab+SOC or placebo+SOC in 24W DB phase, followed by an option to enter the OLE phase. Efficacy and safety were evaluated in seropositive (anti-AChR positive, anti-MuSK positive, and/or anti-LRP4 positive) patients who received ≥1 dose of study treatment.
Results:
In the seropositive efficacy analysis set (N=137) during OLE, total duration of treatment (median [range]) for placebo/nipocalimab (n=66) and nipocalimab/nipocalimab (n=71) groups was 69.1W (8–128) and 62.1W (8–128) respectively. The mean (SD) change-from-baseline (CFB) in MG-ADL scores from DB baseline for those who reached 96W of treatment with placebo/nipocalimab and nipocalimab/nipocalimab groups was –6.69 (3.39) and –6.47 (4.62), and CFB in Quantitative Myasthenia Gravis (QMG) scores was –5.81 (4.11) and –5.97 (4.97) respectively. The mean (SD) percent CFB in IgG for placebo/nipocalimab group was –63.24 (14.31) and for nipocalimab/nipocalimab group was –64.06 (12.91). No new safety concerns were reported in OLE phase.
Conclusions:
In autoantibody-positive patients with gMG, long-term treatment with nipocalimab demonstrated sustained disease control through the 24-week phase 3 Vivacity-MG3 study and the 96-week OLE (120 weeks total).
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