Omidubicel is a first-in-class, advanced nicotinamide-enabled stem cell therapy candidate being evaluated as the first potential allogeneic advanced cell therapy donor source for individuals with blood cancers in need of a transplant.
Results of a new health economic and outcome study have found improved health equity and outcomes associated with omidubicel in patients with blood cancers in need of a transplant, according to Gamida Cell.
Omidubicel is a first-in-class, advanced nicotinamide (NAM)-enabled stem cell therapy candidate with breakthrough and orphan drug designations. It is being evaluated as the first potential allogeneic advanced cell therapy donor source for individuals with blood cancers in need of a transplant, according to the study.
Researchers used a decision-tree model to project allo-hematocrit (allo-HCT) access and clinical outcomes in a hypothetical population of 10,000 allo-HCT-eligible patients in the United States with hematologic malignancies without an available match-related donor. The study found that broad use of omidubicel would extend access for allo-HCT-eligible patients, decrease time to transplant, and improve clinical outcomes, notably among racial and ethnic groups with worse status quo outcomes.
The projected increases in 1-year overall survival ranged from 2.5% to white patients to 6.3% for Black patients. The study also concluded that higher levels of modeled omidubicel uptake were associated with greater improvements in clinical outcomes and greater reductions in racial disparities.
“Today, minority groups comprise only about 30% of all allogeneic hematopoietic stem cell transplants, indicating that lack of access to a matched donor is a significant barrier to treatment in the current landscape,” said Julian Adams, PhD, CEO of Gamida Cell, in a press release.
Earlier research indicated that non-white patients have a lower likelihood of finding an appropriate match in the United States public donor registries, with Black patients having between a 16% and 20% chance of finding an appropriate match. Given that an allogeneic stem cell transplant is intended as a curative option, a lack of an appropriate match could mean an inability to obtain curative treatment.
The phase 3 study of omidubicel demonstrated the ability of the therapy to be used as a donor source for racially and ethnically diverse patients, with 40% of patients enrolled in the study being non-white.
Omidubicel is also being investigated in a phase 1/2 clinical trial in patients with severe aplastic anemia. Results of the health economic and outcome study were presented in a poster at the 2022 Transplantation and Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research.
“This study is encouraging in that it projects that broad access to omidubicel has the potential to open up allo-HSCT as an effective treatment for more patients and address the barriers that have contributed to this alarming health disparity,” Adams said in the press release. “These data are particularly encouraging as we continue to advance our rolling [Biologics License Application] submission to the FDA and move closer to bringing the therapy to more patients in need.”
Gamida Cell Announces Results of New Health Economic and Outcome Study Reporting Improved Health Equity and Health Outcomes With Omidubicel at 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings. News release. Gamida Cell; April 25, 2022. Accessed April 25, 2022. https://investors.gamida-cell.com/news-events/press-releases/news-release-details/gamida-cell-announces-results-new-health-economic