Exploring Long-Term Efficacy of Inebilizumab in Phase 3 Myasthenia Gravis Trial: Richard Nowak, MD, MS

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"Patients were also able to enroll in the open-label extension, so we will have additional data forthcoming for up to 3 years of follow-up of patients on [inebilizumab]. I think not only do we have positive results from the phase 3 [MINT] trial and some of the extended time points to date, but we will also have additional open-label extension data in the next 6 to 12 months."

Autoreactive B-cells contribute to the onset and progression of generalized myasthenia gravis (gMG) through their role in autoantibody production. Targeting these cells, monoclonal antibody inebilizumab (Uplizna; Amgen), an FDA-approved treatment for neuromyelitis optica spectrum disorder, is currently being investigated in the phase 3 MINT trial (NCT04524273) as a potential therapy for patients with gMG. Prior data from MINT showed that the study met its primary efficacy end point, with a significant improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score observed at 26 weeks in patients living with gMG.^1,2

Newly presented results from the phase 3 MINT trial revealed that inebilizumab selectively depleted B-cells and provided durable improvement through 52 weeks in patients with acetylcholine receptor antibody–positive (AChR+) gMG. Presented at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) meeting, held October 29 to November 1, in San Francisco, California, by lead author Richard Nowak, MD, MS, associate professor of neurology at Yale School of Medicine, the study randomized 238 participants with gMG 1:1 to receive 300-mg of intravenous inebilizumab or placebo, including 190 participants who were AChR+.²

In an interview with CGTLive^®, our sister publication, Nowak discussed the 52-week follow-up data presented at AANEM 2025 from the phase 3 MINT trial evaluating inebilizumab for gMG. He noted that the results showed continued clinical improvement across MG-ADL and Quantitative Myasthenia Gravis scores. Nowak emphasized the treatment’s dual evidence for efficacy and safety, as well as its twice-yearly dosing schedule and associated corticosteroid taper. He also underscored the need for predictive biomarkers to better guide treatment response and disease progression in gMG. Additionally, he noted that ongoing open-label extension and biomarker studies are expected to provide additional insights into long-term outcomes and mechanisms of response.

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REFERENCES
1. Amgen Conference Call to Discuss New Topline Data in Inflammation and Rare Disease. News release. Amgen. September 24, 2024. Accessed October 24, 2024. https://amgen2.rev.vbrick.com/#/videos/750c4b9d-5c91-4634-8906-a16b53f346bf.
2. Nowak RJ, Benatar M, Ciafaloni E, et al. A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis. N Engl J Med. 2025;392(23):2309-2320. doi:10.1056/NEJMoa2501561
3. Nowak RJ, Utsugisawa K, Benatar M, et al. Myasthenia Gravis Inebilizumab Trial (MINT): Efficacy, Pharmacodynamics, and Immunogenicity in AChR+ Cohort (Week 52). Presented at: 2025 AANEM; October 29 to November 1; San Francisco, California. Abstract 61. Accessed October 31, 2025. https://qrcodedochub.com/prd/index.html?content-id=776&doc-id=1021&action=view