Chief Endpoints and Potential Significance: Phase 3b OLIKOS Trial

Jeffrey Cohen, MD, professor of neurology and staff physician at the Cleveland Clinic Mellen Center for Multiple Sclerosis, discusses interim BREAKFREE-2 findings for zola-cel, a CD19-directed CAR T cell therapy, in relapsing and progressive MS.

Kim Henriksen, PhD, discusses research evaluating blood-based biomarkers of blood-brain barrier remodeling and immune cell activity in multiple sclerosis, including their potential to track treatment responses and inform future biomarker development.

Terrie Livingston, PharmD, vice president of medical affairs at Octave Bioscience, discussed the evolving role of blood-based biomarkers in multiple sclerosis care.

New biomarker data showed smaller post-onset increases in plasma neurofilament light chain and glial fibrillary acidic protein with privosegtor added to steroids in patients with acute optic neuritis.

Phase 3 data show the oral BTK inhibitor reduced annualized relapse rate by 35.2% and 31.2% vs teriflunomide, with no liver safety signal or Hy's Law cases.

A phase 2 trial found liposomal mitoxantrone hydrochloride had an acceptable safety profile and a potential trend toward fewer relapses in neuromyelitis optica spectrum disorder.

The phase 2 FENerations1 study is an open-label, single-arm, small-scale study evaluating fenebrutinib dosing in 8 to 12 children and adolescents with relapsing MS.

Updated data from Breakfree-2 study showed that treatment with a single zola-cel infusion achieved NEDA-3 in highly active relapsing multiple sclerosis and led to mostly stable disability in progressive multiple sclerosis.