BOSTON–(BUSINESS WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced the presentation of data supporting the potential of omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant at the 2022 Cord Blood Connect Meeting, being held in South Beach, Florida. “We continue to be encouraged by the growing body of evidence supporting the improved outcomes and lower infection rates seen in patients treated with omidubicel as well as the superior health-related quality of life scores compared to transplantation with UCB. We also demonstrated the potential role for omidubicel to address the unmet need for patients who are currently eligible for transplant, but cannot find a match,” said Julian Adams, chief executive officer of Gamida Cell. “Our omidubicel BLA was accepted by the FDA and granted priority review with a PDUFA date of January 30, 2023, which we believe further underscores the unmet need for patients with blood cancers in need of a stem cell transplant.”
Gamida Cell presented a poster titled “Health-Related Quality of Life (HRQL) Following Transplantation with Omidubicel Versus Umbilical Cord Blood (UCB) in Patients with Hematological Malignancies: Results from a Phase III Randomized, Multicenter Study,” which included an analysis of 75 patients to evaluate changes in HRQL measures between the two study arms. Outcomes evaluated included Functional Assessment of Cancer Therapy General (FACT-G) domain scores for physical, social/family, functional and emotional well-being, and EQ-5D-3L index scores at days 42, 100, 180 and 365 post-transplant. During the first-year post-transplant, patients receiving omidubicel had numerically superior average FACT-G domain and EQ-5D-3L index scores compared to UCB, with mean differences across time points ranging from 1.4-3.1 for physical well-being, 0-1.3 for social/family well-being, 0.5-1.4 for emotional well-being, 1.6-3.2 for functional well-being, and 0.03-0.09 for the EQ-5D-3L index score. The data suggest meaningfully greater preservation or improvement of important HRQL domains in patients treated with omidubicel compared to UCB.
Gamida Cell also presented a poster titled “Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the US,” which featured an analysis of projected impact of allogeneic hematopoietic cell transplant (allo-HCT) access and clinical outcomes in a hypothetical population of 10,000 allo-HCT-eligible patients with hematologic malignancies lacking an HLA-matched related donor. Assuming 20% omidubicel use, the proportion of patients receiving allo-HCT increased by 71% in Black, 43% in Asian, 30% in Hispanic, and 5% in white patients. The model suggests that access to omidubicel, upon approval, is projected to decrease time to allo-HCT and improve patient outcomes, with the greatest improvements among the racial and ethnic groups underserved by the current standard of care.
In a poster titled “Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel Leads to Robust Recovery and Diversity of T cells” patients treated with omidubicel were found to have robust and diverse T cell constitution. In an analysis of the T-cell development of 37 patients, patients transplanted with omidubicel demonstrated higher numbers of Recent Thymic Emigrants (RTEs) in peripheral blood at one year post transplant compared to transplantation with UCB, which suggest faster thymopoiesis and provide mechanistic rational for the lower infection rates and improved outcomes in these patients.
All three posters were made available beginning Saturday, September 10, 2022, 6:15-7:45 p.m. ET, during the 2022 Cord Blood Connect Meeting.