Bristol Myers Squibb’s Breakfree-2 results, announced on October 23, 2026, showed preliminary multiple sclerosis efficacy signals for its investigational CAR T-cell therapy, with all 60 patients at the second dose level remaining off disease-modifying therapies at last follow-up. The early-stage findings also included serious safety events, including severe neurotoxicity and a fatal case of septic pneumonia after the data cutoff.
Key Takeaways
- All 60 patients at dose level 2 remained off disease-modifying therapies, but only nine had more than 12 months of follow-up.
- Safety findings included one Grade 4 neurotoxicity event and a death from septic pneumonia after the data cutoff.
- The Phase 1 study had no control group and was designed primarily to assess safety, limiting conclusions about effectiveness.
Table of Contents
- Breakfree-2 results offer an early efficacy signal
- Smaller follow-up groups show disease stability
- Serious adverse events qualify the safety findings
- Conclusion
Breakfree-2 results offer an early efficacy signal
Bristol Myers Squibb presented the interim findings at MSToronto 2026. The trial evaluates zolacabtagene autoleucel, also called zola-cel, an investigational CD19-directed CAR T-cell therapy made from a patient’s own T cells.
The company’s interim Breakfree-2 announcement describes a Phase 1, single-arm, dose-escalation study involving patients whose disease remained active or whose disability worsened despite treatment. Safety was the primary endpoint; efficacy was secondary.
Among patients receiving dose level 2, all 60 remained off disease-modifying therapies at last follow-up. Nine had been followed for more than 12 months. Remaining off those medicines is an encouraging observation, but it does not establish durable treatment-free remission.
| Item | Details |
|---|---|
| Study population | 66 patients: 30 with highly active relapsing MS and 36 with progressive MS. |
| Previous treatment | Median of two prior disease-modifying therapies. |
| Treatment process | T-cell collection and manufacturing, followed by lymphodepletion and a single zola-cel infusion. |
| Study scope | Breakfree-2 also evaluates zola-cel in refractory myasthenia gravis; the disclosed results concern MS cohorts. |
Smaller follow-up groups show disease stability
The efficacy analysis at week 26 or later covered 32 evaluable patients treated at dose level 2, rather than the full study population.
Six of seven evaluable patients with highly active relapsing MS met the criteria for no evidence of disease activity. All eight evaluable for the Expanded Disability Status Scale showed stability or improvement.
Among patients with progressive MS, 22 of 24 showed stability or improvement in disability despite worsening before treatment, and all 24 had no new MRI activity. These findings support further investigation, but the small groups and absence of a control arm do not establish how zola-cel compares with other treatments.
Serious adverse events qualify the safety findings
Bristol Myers said most adverse events were brief and reversible. Cytokine release syndrome occurred in 28 of 66 patients, predominantly at Grade 1, and resolved in a median of two days.
Five patients experienced immune effector cell-associated neurotoxicity syndrome, or ICANS. One patient with progressive MS had a Grade 4 event that resolved within four days after treatment with corticosteroids and anakinra.
After the data cutoff, a patient with highly active relapsing MS died from septic pneumonia 44 days after infusion. The patient had developed late-onset motor symptoms described as non-ICANS that did not resolve with intermittent corticosteroids and intravenous immunoglobulin. High-dose cyclophosphamide was subsequently administered; septic pneumonia developed, and the patient died the following day.
The announcement did not establish that zola-cel caused the death. Bristol Myers reported no additional Grade 5 events across its autoimmune-disease zola-cel programs, which included 190 patients treated in Phase 1 studies. Zola-cel remains investigational.
Conclusion
The Breakfree-2 results provide an early development signal for Bristol Myers Squibb’s autoimmune cell-therapy program, not proof of lasting remission or established safety. Longer follow-up and further safety assessment remain central to judging whether the observed disease control persists.
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