5 Key Takeaways

• 1

  A patient with highly active relapsing multiple sclerosis died 44 days after receiving zola-cel in a Phase I trial.

• 2

  The patient developed delayed motor symptoms that BMS did not classify as ICANS; symptoms persisted despite corticosteroids and intravenous immunoglobulin.

• 3

  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.

• 4

  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.

• 5

  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.