BMS Details Patient Death in Zola-Cel Multiple Sclerosis Trial

The company also reported early efficacy and safety data from the Phase I Breakfree-2 study

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A patient with highly active relapsing multiple sclerosis died 44 days after receiving zola-cel in a Phase I trial.
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The patient developed delayed motor symptoms that BMS did not classify as ICANS; symptoms persisted despite corticosteroids and intravenous immunoglobulin.
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After high-dose cyclophosphamide, the patient developed septic pneumonia and died the following day; BMS reported no other deaths among 190 patients treated in autoimmune-disease studies.
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In Breakfree-2, cytokine release syndrome occurred in 28 of 66 participants, and five developed ICANS, including one grade 4 event that resolved within four days.
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Among seven evaluable participants with highly active relapsing MS and at least 26 weeks of follow-up, six had no relapses, disability progression, or new MRI activity.

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