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SOHO 2021: Update on BCMA-Directed CAR T-Cell Therapy for Resistant Myeloma

By: Lauren Harrison, MS
Posted: Monday, September 20, 2021

A single dose of ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy, produced “early, deep, and durable” responses among patients who had heavily pretreated relapsed or refractory multiple myeloma. This study was presented during the 2021 Society of Hematologic Oncology (SOHO) Annual Meeting by Saad Z. Usmani, MD, of the Levine Cancer Institute–Atrium Health in Charlotte, North Carolina (Abstract MM-119).

This phase Ib/2 study enrolled 97 patients with relapsed or recurrent multiple myeloma who had received at least 3 prior treatment regimens and anti-CD38. Patients underwent lymphodepletion with cyclophosphamide/fludarabine; they were then treated with one infusion of ciltacabtagene autoleucel at a targeted dose of 0.75 x 106 CAR T cells/kg. Patients were followed for a median of 12.4 months.

The overall response rate was 97%, and 67% of patients achieved a stringent complete response. The median time to first response was 1 month, and the median time to a complete response or better was 2 months. The median duration of response was not yet reached. The 12-month progression-free survival rate was 77%, and the overall survival rate was 89%. There were 57 patients who were evaluable for measurable residual disease (MRD), and 93% of them achieved MRD negativity.

Grade 3 or 4 adverse events included neutropenia (95%), anemia (68%), leukopenia (61%), thrombocytopenia (60%), and lymphopenia (50%). Most patients (95%) experienced cytokine-release syndrome, although just 4% of patients had grade 3 or 4 cytokine-release syndrome. In addition, CAR T-cell neurotoxicity occurred in 21% of patients. There were 14 deaths reported over the course of the study, 12 of which occurred more than 100 days after the infusion. Five of these deaths were thought to be due to disease progression and four, to treatment-related adverse events.

Disclosure: No disclosure information was provided.



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