Dr. Giralt on Omidubicel Vs Standard Umbilical Cord Blood Transplant in Hematologic Malignancies

Sergio A. Giralt, MD, deputy division head, Division of Hematologic Malignancies, Melvin Berlin Family Chair in Multiple Myeloma, Memorial Sloan Kettering Cancer Center, discusses the results of a phase 3 trial (NCT02730299) comparing omidubicel with standard umbilical cord blood transplant (UCBT) in hematologic malignancies.

During the 47th Annual Meeting of the EBMT, the results of a phase 3 trial of omidubicel, a cryopreserved cellular product derived from a single umbilical cord blood unit and expanded ex vivo, vs standard UCBT in patients with high-risk hematologic malignancies following myeloablation were presented virtually. The findings demonstrated a 124-fold improvement in CD34-positive cell expansion with omidubicel vs UCBT at 9 x 10⁶ cells/kg and 0.3 x 10⁶ cells/kg, respectively. The median time to neutrophil engraftment was 12 days with omidubicel vs 22 days with UCBT. Non-relapse mortality at 180 days after treatment, 1-year relapse rate, and 1-year probability of overall survival did not differ significantly between arms but favored omidubicel.

Additionally, patients who received omidubicel had a higher incidence of 42-day platelet engraftment, a lower incidence of grade 2 or 3 bacterial or invasive fungal infection, and spent less time hospitalized within 100 days after transplant compared with standard UBCT.

Comparative trials of omidubicel vs haploidentical transplant with post-transplant cyclophosphamide could shed additional light on the utility of omidubicel in this patient population, concludes Giralt.