Cilta-cel LEGEND-2 Data Show Impressive OS in Relapsed or Refractory MM

Patients with relapsed or refractory multiple myeloma (MM) treated with LCAR-B38M—known in the United States as ciltacabtagene autolecuce (cilta-cel)—had a median overall survival (OS) approaching five years, according to data from LEGEND-2.

Researchers presented long-term remission and survival data during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The data were from patients in the study who received LCAR-B38M, a dual epitope-binding chimeric antigen receptor (CAR) T-cell therapy directed against two distinct BCMA epitopes.

Previously presented results from the study showed encouraging efficacy and manageable safety in the 74 treated patients. Dr. Mi presented results from patients with at least five years’ follow-up, the longest for any BCMA-targeted CAR T-cell therapy study.

In LEGEND-2, patients underwent lymphodepletion with cyclophosphamide 300 mg/m² (n=66) or 250 mg/m² plus fludarabine 25 mg/m² (n=8) prior to receiving LCAR-B38M in a single (n=9) or three split (n=65) infusions.

As of November 2022, the median follow-up was 65.4 months and 74 patients had received LCAR-B38M.

The overall response rate was 87.8% with 73% of patients achieving complete response. The measurable residual disease-negative complete response rate was 67.6%, with a median duration of response of 23 months. Median progression-free survival was the same as previously reported.

Median OS was 55.8 months, with almost half (44.6%) of patients alive and 17.6% still disease free.

The researchers identified factors associated with disease progression. Patients without progressive disease were more likely to have baseline Eastern Cooperative Oncology Group performance status of 0, immunoglobulin G type MM, International Staging System stage I MM, numerically shorter time from diagnosis, fewer prior lines of therapy, no light chain MM, and no extramedullary disease.

Cilta-cel gained FDA approval for relapsed or refractory MM in February 2022 based on the initial results of CARTITUDE-1.

Reference

J-Q Mi, W-H Zhao, L-J Chen, et al. Long-term remission and survival in patients with relapsed or refractory multiple myeloma after treatment of LCAR-B38M CAR-T: at least 5-year follow-up in LEGEND-2. Abstract #8010. Presented at the 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023; Chicago, Illinois.