Bristol Myers Squibb Presents Results from Phase 1 Breakfree-2 Study of Zolacabtagene Autoleucel (BMS-986353) in Patients with Highly Active Relapsing and Progressive Forms of Multiple Sclerosis at MSToronto 2026
Key Highlights
- ➤60/60 DL2 patients remained off disease-modifying therapies after zola-cel treatment
- ➤42.4% of patients experienced cytokine release syndrome; all resolved in median two days
- ➤One fatal septic pneumonia occurred 44 days after infusion in a haRMS patient
- ➤Six of seven evaluable haRMS patients achieved no evidence of disease activity
- ➤22 of 24 progressive MS patients showed stable or improved disability progression
Expert Statements
Jeffrey A. Cohen, Professor of Neurology and Staff Physician, Mellen Center, Cleveland Clinic
“People living with relapsing and progressive forms of multiple sclerosis need treatment options that address the underlying disease while helping control relapses and preserve function.”
Jeffrey A. Cohen, Professor of Neurology and Staff Physician, Mellen Center, Cleveland Clinic
“These data suggest that CD19-directed CAR T cell therapy may offer a new approach to treating multiple sclerosis.”
Jeffrey A. Cohen, Professor of Neurology and Staff Physician, Mellen Center, Cleveland Clinic
“While more research is needed, the potential to control relapses, stabilize disability and reduce reliance on disease-modifying medications is encouraging.”
Lynelle B. Hoch, President, Cell Therapy Organization, Bristol Myers Squibb
“BMS is at the forefront of cell therapy science, pioneering a new era by exploring the potential for immune reset in patients living with autoimmune diseases.”
Lynelle B. Hoch, President, Cell Therapy Organization, Bristol Myers Squibb
“The Breakfree-2 data demonstrate clinical potential for zola-cel in multiple sclerosis, showcasing the opportunity for treatment-free remission in patients who have depended on chronic therapies for years.”
Lynelle B. Hoch, President, Cell Therapy Organization, Bristol Myers Squibb
“We are advancing zola-cel with the goal to redefine autoimmune care with a single, transformative treatment.”
Bristol Myers Squibb Presents Results from Phase 1 Breakfree-2 Study of Zolacabtagene Autoleucel (BMS-986353) in Patients with Highly Active Relapsing and Progressive Forms of Multiple Sclerosis at MSToronto 2026
Data reinforce the potential for immune reset with zolacabtagene autoleucel to address an underlying cause of multiple sclerosis
Get started
Create a free account to read the full story.