Mitchell Horwitz, MD, on Omidubicel’s Value for Racially Diverse Patients Receiving AlloHCT
The professor of medicine at Duke Cancer Institute discussed findings from an early access program of the therapy, recently approved as Omisirge.
“The outcomes were very similar to what we observed in the phase three study, in the sense that there appeared to be a correlation between the number of CD 34 Positive stem cells infused and the time to neutrophil recovery... platelet engraftment was also comparable, maybe even a little faster than what we saw in the phase 3 study. So, we were we were reassured that the real-world data is similar to what we saw in the study.”
Outcomes in patients receiving allogeneic hematopoietic cell transplantation (alloHCT) with omidubicel (Gamida Cell) were similar in a real-world early access program (EAP) to those enrolled in the phase 3 registrational study (NCT0273029) that supported its approval as Omisirge in April 2023.1,2
Data from the EAP were presented at the 2024 Tandem Meetings |Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, held in San Antonio, Texas, February 21-24, 2024, by Mitchell Horwitz, MD, professor of medicine and cell transplant specialist, Duke University Cancer Institute.
CGTLive® spoke with Horwitz to learn more about the findings from the EAP and how they compared with the phase 3 trial. He noted that enrollment was similarly ethnically diverse between the EAP and trial and stressed that the findings support the use of omidubicel as a viable donor source for alloHCT for patients from diverse racial backgrounds who were less likely to have a suitable adult matched adult donor.
View more coverage of the 2024 Tandem Meeting now.
REFERENCES
1. Horwitz M, Schiller GJ, Tsai SB, et al. Omidubicel-Onlv for Allogeneic Transplantation (allo-HCT) in Patients with Hematologic Malignancies: Results of a Multicenter Open-Label Expanded Access Program (EAP). Presented at: 2024 Tandem Meetings, February 21-24, San Antonio, Texas. Abstract #313
2. FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation. News release. FDA. April 17, 2023. Accessed April 17, 2023.https://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell
FDA Announces Probe Into bluebird's Elivaldogene Autotemcel for Hematologic Malignancies
November 27th 2024Approved as Skysona, the therapy has been reported to be related to cases of hematologic malignancies, including life-threatening instances of myelodysplastic syndrome and acute myeloid leukemia.
