Gamida Cell’s Omisirge Administered to First Patient in Commercial Setting

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The company also announced it has onboarded 15 transplant centers in the United States for the use of omidubicel, thus exceeding the goal it had set for itself for 2023.

The first patient has been treated in the commercial setting with Gamida Cell's Omisirge (omidubicel-onlv), an FDA-approved allogeneic hematopoietic stem cell (HSC) therapy intended to reduce the risk of infection and decrease the time for neutrophil recovery for patients with hematologic cancer undergoing umbilical cord blood transplantation after myeloablative conditioning.1

“This is a significant milestone for Gamida Cell, advancing our mission of delivering potentially curative therapies to patients with cancer,” Abbey Jenkins, MS, the president and chief executive officer of Gamida Cell, said in a statement.1 “This patient will be the first of many who have new hope for a cure thanks to the availability of Omisirge as a new stem cell transplant donor source. This is why we do the work that we do – to make a difference for people with cancer.”

The milestone is one of multiple successes Gamida Cell has accumulated during its launch of the cell therapy product. Thus far it has onboarded 15 transplant centers in the United States for the use of omidubicel, thus exceeding the goal it had set for itself for 2023. Furthermore, the company noted that among the top 70 transplant centers, more than 90% are actively engaged with Gamida Cell, and that Gamida Cell Assist, a program that indicates that a transplanter has chosen to use omidubicel as a donor source, is enrolling more and more patients.

“The launch of Omisirge is progressing very well in terms of payer coverage, transplant center onboarding, and transplanter interest in using Omisirge as a donor source,” Michele Korfin, RPh, MBA, the chief operating and chief commercial officer of Gamida Cell, added to the statement.1 “We recognize the importance of making sure eligible patients can access Omisirge. To appropriately manage our cash, we launched with a limited investment and field footprint. The positive launch progress and strong interest from transplant centers now warrant expanding that investment and the team from 4 to 8 account managers by the start of 2024. We are encouraged by transplanter feedback that Omisirge may both increase the number of patients able to access an appropriate donor source and address some limitations of other donor sources.”

Omidubicel is delivered as a single intravenous infusion composed of substantially modified patient-specific human allogeneic cord blood-derived stem cells that have been processed and cultured with nicotinomide, a form of vitamin B3.2 The cell therapy was approved by the FDA on April 17, 2023, with an indication for patients aged 12 years and older with plans to undergo umbilical cord blood transplantation after myeloablative conditioning for hematologic cancer. The FDA’s decision was based on results from a global, randomized phase 3 clinical trial (NCT02730299) that assessed omidubicel against unmanipulated cord blood units in 125 patients with acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, or lymphoma who were eligible for allogeneic transplant.1,2

Patients in the omidubicel arm of the study had a faster median time to neutrophil engraftment (12 days vs 22 days, 95% CI, P < .001), a 96% cumulative incidence of neutrophil engraftment (vs 89% for the control arm), faster platelet recovery (55% vs 35% recovery by 42 days; P = .028), and had a higher median number of days out of the hospital in the first 100 days after transplant (61 vs 48 days; P = .005).3 Additionally, a lower incidence of first grade 2 to 3 bacterial or invasive fungal infections was observed in the omidubicel arm (37%) compared to the control arm (57%) (P = .027).

“Many patients don't have an optimal stem cell donor, and omidubicel adds a new option to our armamentarium,” Chenyu Lin, MD, a hematology/oncology fellow at Duke Cancer Institute of Duke University, told CGTLive™ at the time of omidubicel’s approval. “In particular, those patients needing an umbilical cord blood transplant will have the benefit of using an approach with demonstrated safety. The studies have shown that omidubicel is associated with faster recovery of blood counts, a lower risk of infection, shorter hospital stays, and better quality of life compared to conventional cord blood transplants."

REFERENCES
1. First patient receives Gamida Cell's Omisirge™ (omidubicel-onlv). News release. Gamida Cell Ltd. September 27, 2023. Accessed October 3, 2023. https://investors.gamida-cell.com/news-events/press-releases/news-release-details/first-patient-receives-gamida-cells-omisirgetm
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 October 3, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell
3. Horwitz ME, Stiff PJ, Cutler C, et al. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021;138(16):1429-1440. doi:10.1182/blood.2021011719
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