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Multicenter Long-Term Follow-Up of Allogeneic Hematopoietic Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials. Transplantation and cellular therapy Lin, C., Schwarzbach, A., Sanz, J., Montesinos, P., Stiff, P., Parikh, S., Brunstein, C., Cutler, C., Lindemans, C. A., Hanna, R., Koh, L. P., Jagasia, M. H., Valcarcel, D., Maziarz, R. T., Keating, A. K., Hwang, W. Y., Rezvani, A. R., Karras, N. A., Fernandes, J. F., Rocha, V., Badell, I., Ram, R., Schiller, G. J., Volodin, L., Walters, M. C., Hamerschlak, N., Cilloni, D., Frankfurt, O., McGuirk, J. P., Kurtzberg, J., Sanz, G., Simantov, R., Horwitz, M. E. 2023

Abstract

Omidubicel is a cord blood derived ex vivo-expanded cell therapy product that has demonstrated faster engraftment and fewer infections compared with unmanipulated umbilical cord blood (UCB) in allogeneic hematopoietic cell transplantation. While the early benefits of omidubicel have been established, long-term outcomes are still unknown. We report on a planned pooled analysis of five multi-center clinical trials, featuring 105 patients with hematologic malignancies or sickle cell hemoglobinopathy who underwent omidubicel transplantation at 26 academic transplant centers worldwide. With a median follow-up of 22 months (range, 0.3-122), the 3-year estimated overall survival and disease-free survival were 62.5% and 54.0%, respectively. With up to 10 years follow-up, omidubicel showed durable trilineage hematopoiesis. Serial quantitative assessments of CD3+, CD4+, CD8+, CD19+, CD116+CD56+, and CD123+ immune subsets revealed median counts remaining within normal range through up to 8 years follow-up. Secondary graft failure occurred in 5 patients (5%) in the first year, with no late cases reported. One case of donor-derived myeloid neoplasm was reported at 40 months post-transplant. This was also observed in a control arm patient who received only unmanipulated UCB. In conclusion, omidubicel demonstrated stable trilineage hematopoiesis, immune competence, and graft durability in extended follow-up.

View details for DOI 10.1016/j.jtct.2023.01.031

View details for PubMedID 36775201