Abstract Details

Title Long-term Safety and Efficacy of Nipocalimab in Generalized Myasthenia Gravis: Vivacity-MG3 Open-label Extension Phase Results

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) P7 - Poster Session 7 (5:00 PM-6:00 PM)

Poster/Presentation
Number 11-022

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.

Authors/Disclosures
Constantine Farmakidis, MD, FAAN PRESENTER	Dr. Farmakidis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Farmakidis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for J&J. Dr. Farmakidis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Muscular Dystrophy Association.
Carlo Antozzi, MD	Dr. antozzi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx. Dr. antozzi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for janssen. Dr. antozzi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for argenx. Dr. antozzi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson Johnson.
Tuan H. Vu, MD (University of South Florida)	Dr. Vu has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Dianthus. Dr. Vu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Vu has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NMD Pharma. Dr. Vu has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ARGENX. Dr. Vu has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Vu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Vu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen (Horizon). Dr. Vu has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Johnson & Johnson. Dr. Vu has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Alexion. Dr. Vu has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for CSL Behring. Dr. Vu has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Argenx. The institution of Dr. Vu has received research support from CSL Behring. The institution of Dr. Vu has received research support from Alexion. The institution of Dr. Vu has received research support from RA Pharma/UCB. The institution of Dr. Vu has received research support from Mass Gen Hospital/Healy Platform Study. The institution of Dr. Vu has received research support from ARGENX. The institution of Dr. Vu has received research support from Horizon/Amgen. The institution of Dr. Vu has received research support from Woolsey Pharma. The institution of Dr. Vu has received research support from CSL Behring. The institution of Dr. Vu has received research support from Cartesian Therapeutics. The institution of Dr. Vu has received research support from Janssen/Johnson & Johnson. The institution of Dr. Vu has received research support from Immunovant. The institution of Dr. Vu has received research support from Regeneron. The institution of Dr. Vu has received research support from Dianthus. The institution of Dr. Vu has received research support from COUR.
Sindhu Ramchandren	No disclosure on file
Richard J. Nowak, MD (Yale University School of Medicine)	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.
Vera Bril, MD (Toronto General Hospital)	Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octapharma. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Powell Mansfield. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Akcea. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ionis. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Momenta (now J&J). Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NovoNordisk. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunovant. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Bril has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Akcea. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. The institution of Dr. Bril has received research support from UCB. The institution of Dr. Bril has received research support from Argenx. The institution of Dr. Bril has received research support from Momenta (now J&J). The institution of Dr. Bril has received research support from Immunovant. The institution of Dr. Bril has received research support from Alexion. The institution of Dr. Bril has received research support from Takeda. The institution of Dr. Bril has received research support from Grifols. The institution of Dr. Bril has received research support from CSL. The institution of Dr. Bril has received research support from Octapharma. The institution of Dr. Bril has received research support from Akcea. The institution of Dr. Bril has received research support from Ionis. The institution of Dr. Bril has received research support from Viela Bio (now Horizon). Dr. Bril has received intellectual property interests from a discovery or technology relating to health care.
Jan L. De Bleecker, MD, PhD, FAAN (Neurology/University Hospital)	Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ArgNX. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving as a Consultant for Biogen. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson and Johnson. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. De Bleecker has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for CSL Behring. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL Behring. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. De Bleecker has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen pharmaceuticals. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amicus. Dr. De Bleecker has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abcuro.
Huan Yang (Neurology, Xiangya Hospital, Central South University, Changsha, China)	No disclosure on file
Eduard Minks (First Department of Neurology, Faculty of Medicine, Masaryk University and St. Anne’s Hospital, Brno, Czech Republic)	Eduard Minks has nothing to disclose.
Jin-Sung Park, MD, PhD	Prof. Park has nothing to disclose.
Mariusz P. Grudniak, MD, PhD	Dr. Grudniak has nothing to disclose.
Marek Smilowski (Klinika Hematologii i Transplantacji Szpiku)	Marek Smilowski has nothing to disclose.
Teresa Sevilla	Teresa Sevilla has nothing to disclose.
Sarah Hoffmann, MD, PhD	Prof. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Prof. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Prof. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Argenx. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Grifols. The institution of Prof. Hoffmann has received research support from Janssen. The institution of Prof. Hoffmann has received research support from Argenx.
Kumaraswamy Sivakumar, MD, MRCP	Dr. Sivakumar has nothing to disclose.
Eriene Wasef, PharmD	Dr. Wasef has received personal compensation for serving as an employee of Johnson &Johnson. Dr. Wasef has stock in Johnson & Johnson.
Panna Sanga, MBBS	Dr. Sanga has received personal compensation for serving as an employee of Johnson & Johnson . Dr. Sanga has stock in Johnson & Johnson .
Keith Karcher, MS	Mr. Karcher has received personal compensation for serving as an employee of Janssen Research and Develop,ent. Mr. Karcher has stock in Johnson & Johnson.
Yaowei Zhu, PhD (Janssen Research & Development, LLC)	Dr. Zhu has received personal compensation for serving as an employee of Johnson & Johnson.
John Sheehan, PhD	Dr. Sheehan has received personal compensation for serving as an employee of Johnson and Johnson. An immediate family member of Dr. Sheehan has received personal compensation for serving as an employee of PMVParma. Dr. Sheehan has stock in Johnson and Johnson. An immediate family member of Dr. Sheehan has stock in PMVPharma.
Hong Sun, MD, PhD (Janssen)	Dr. Sun has received personal compensation for serving as an employee of Janssen.

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