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EBMT 2021 | Omidubicel versus standard UCB transplantation

Guillermo Sanz, MD, PhD, University Hospital La Fe, Valencia, Spain, gives a summary of the results of a Phase III trial (NCT02730299) comparing omidubicel with standard umbilical cord blood (UCB) transplantation in patients with high-risk hematologic malignancies who do not have a suitable matched donor. Omidubicel is a cryopreserved cellular product which substantially increases CD34+ cell content and has demonstrated efficacious and durable hematopoietic reconstitution in early-stage trials. In this trial, 123 patients were randomized 1:1 to receive either omidubicel or standard UCB. At a median follow-up of 10 months, the median CD34+ cell dose for omidubicel recipients was 9 x 10^6/kg (124-fold CD34+ cell expansion) and 0.3 x 10^6/kg for controls. Overall, the study found that hematopoietic engraftment with omidubicel was faster, reduced early transplant-related complications and resulted in a significant clinical benefit when compared to standard UCB transplantation. This interview took place during the 47th Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT) 2021.

Transcript (edited for clarity)

The main goals of our study were to show if we could shorten the time to neutrophil engraftment, the time to platelet engraftment, the incidence of bacterial, fungal and viral infections, and also to show if there was any advantages in the 100 days alive and out of hospital of the patients transplanted with omidubicel. And we achieved those goals, thus we believe that omidubicel should be, after this trial, the standard of care for patients who need a cord blood transplant...

The main goals of our study were to show if we could shorten the time to neutrophil engraftment, the time to platelet engraftment, the incidence of bacterial, fungal and viral infections, and also to show if there was any advantages in the 100 days alive and out of hospital of the patients transplanted with omidubicel. And we achieved those goals, thus we believe that omidubicel should be, after this trial, the standard of care for patients who need a cord blood transplant.

We were able to demonstrate that omidubicel was capable of allowing a 100 to 130 expansion of the CD34-positive cells in the graft. And in the end, the median number of CD34 cells infused to the patient with omidubicel was nine per 10 to the sixth per kilo, whereas it was only 0.3 per 10 to the sixth per kilo in patients receiving a standard course. And I, I would like to stress that this number of stem cells that are given in a transplant that is expanded with omidubicel, is greater than the one achieved with both bone marrow and peripheral blood transplantation from an adult donor.

And we hypothesize that if we were able to achieve these very high numbers of stem cells in the graft, we could reduce the time from engraftment in patients receiving cord blood transplantation. And that was the case, because patients receiving omidubicel had only 12 days to, sorry, to neutrophil engraftment compared to 22 days in patients receiving a standard cord blood transplantation that in two-thirds of the cases was a double cord blood transplant.

It was the same for platelet engraftment, and we were also able to show a 20% reduction in the number of bacterial and fungal infections in the 100 days after transplant and also in the days alive and out of hospital. In patients transplanted with omidubicel it was 61 days versus 40 days for patient receiving the control transplant.

We are very satisfied with the results of this trial and we believe that omidubicel will receive a very fast approval by the FAD and the EMA regulatory agencies.

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Disclosures

Prof. Guillermo Sanz, MD, PhD, has received research funding from Celgene/BMS, Gamida Cell and Novartis; has received speaker’s fees from Takeda, has received honoraria from Celgene/BMS; has fulfilled a consulting or advisory role for AbbVie, Amgen, Boehringer-Ingelheim, Celgene/BMS, Helsinn Healthcare, Janssen, Novartis, Roche and Takeda, and has received travel and/or accommodation expenses from Celgene/BMS, Gilead, Roche and Takeda.

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