Omidubicel May Provide Long-Term Benefits With Allogeneic Transplantation for Hematologic Malignancies

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Long-term benefits for patients with hematologic malignancies were seen with allogeneic hematopoietic stem cell transplant (allo-HSCT) and omidubicel, in comparison with umbilical cord blood transplant (UCBT). This is according to follow-up results of a phase 3 trial presented at the Tandem Meetings 2022.

Omidubicel is a cell therapy associated with preserved stem cell function and optimized homing and self-renewal, according to the researchers. Earlier trial analyses of primary and secondary endpoints suggested the combination of allo-HSCT and omidubicel was superior to standard UCBT in this study population. In the current analysis, the researchers presented follow-up results from 1 year after transplantation.

The randomized, multicenter study included patients with hematologic malignancies from 7 nations. The follow-up report emphasized endpoints of 1-year nonrelapse mortality (NRM), disease-free survival (DFS), overall survival (OS), relapse, and grade 3 viral infections that occurred by 15 months postrandomization. However, the study was not powered to determine statistical differences between treatment arms for these analyses.


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The median follow-up for the presented analysis was 14 months (range, 1-20 months). The study population consisted of 125 patients, many of whom had acute leukemia and moderate- to high-risk disease. The median patient age was 41 years.

The 1-year cumulative incidence of NRM was 15% for patients receiving allo-HSCT with omidubicel, and it was 29% for patients in the UCBT arm (P =.068). OS rates were 73% for the omidubicel arm and 60% for the UCBT arm (P =.13). The adjusted hazard ratio for mortality trended toward favoring the omidubicel arm, at 0.61 (95% CI, 0.32-1.15; P =.075).

DFS was similar between the treatment arms. The DFS rate was 63% for the omidubicel arm and 56% for the UCBT arm (P =.4). The cumulative incidence of relapse was also similar between arms, at 23% for the omidubicel arm and at 16% for the UCBT arm (P =.32).

The 1-year incidence of grade 3 viral infections was 8% for the omidubicel arm and 27% for the UCBT arm (P =.04). The 1-year incidence of grade 2 or 3 bacterial or invasive fungal infections was 45% for the omidubicel arm and 70% for the UCBT arm.

The researchers concluded that use of omidubicel was linked to long-term benefits over UCBT in terms of 1-year NRM and relapse rates. They also noted that the OS rates show a trend toward favoring the omidubicel arm over time, and they considered the option of using omidubicel to be supported by its clinical benefit.

Read more of Cancer Therapy Advisor’s coverage of Tandem Meetings 2022 by visiting the conference page.

Reference

Horwitz ME, Stiff P, Cutler C, et al. Allogeneic hematopoietic stem cell (allo-HSCT) transplant with omidubicel demonstrates sustained clinical improvement versus standard myeloablative umbilical cord blood transplantation (UCBT): final results of a phase III randomized, multicenter study. Tandem Meetings 2022; April 23-26, 2022. Abstract 86.

This article originally appeared on Hematology Advisor



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