Cecilia Brown

Cancer Nursing Today nonprod

While rates of graft-versus-host disease (GVHD) after allogeneic hematopoietic stem-cell transplantation &ldquo;remain unacceptably high&rdquo; in many settings, GVHD rates were around 5% in patients receiving Orca-T, a high-precision, regulatory T-cell-engineered donor product, according to investigators.Everett Meyer, MD, PhD, of Stanford University in Palo Alto, California, and colleagues conducted the study to investigate the safety and efficacy of Orca-T in patients with hematologic malignancies. Orca-T is an &ldquo;allogeneic investigational cell therapy product comprised of stem and immune cells that leverages highly purified, polyclonal donor regulatory T-cells to control alloreactive immune responses,&rdquo; Dr. Meyer and colleagues wrote.Samer Srour, MB ChB, MS, of the University of Texas MD Anderson Cancer Center, gave a presentation on the research during the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO).&ldquo;Our goal is to decrease the graft-versus-host disease [incidence] significantly without increasing the relapse [rate],&rdquo; Dr. Srour said during his presentation.Dr. Srour reported on data from a single-center phase I/II study of Orca-T (n=41) and a multicenter phase Ib study (n=97) that both included patients with high-risk hematologic malignancies who received Orca-T.The median patient age was 49 years. Most patients had acute myeloid leukemia (43%), 27% had acute lymphoblastic leukemia, 10% had myelodysplastic syndrome, 7% had myelofibrosis, and 6% had chronic myelogenous leukemia. All patients had at least 100 days of follow-up as of February 28, 2022. The median follow-up was 300 days (range, 27-1941 days).Orca-T was produced from granulocyte colony-stimulating, factor-mobilized peripheral blood from matched related donors (n=72), matched unrelated donors (n=62), or mismatched unrelated donors (n=4).&ldquo;Orca-T was successfully manufactured, distributed, and infused for all patients,&rdquo; the researchers wrote. &ldquo;Overall time from donor centers to recipient centers was under 60 hours in all cases.&rdquo;Most patients received busulfan-based myeloablative conditioning (79%), while 19.5% received total body irradiation-based conditioning, and 1.5% received carmustine-based conditioning. Almost all patients (92%) received single-agent tacrolimus as GVHD prophylaxis, while 7 patients received sirolimus, and 4 patients received tacrolimus plus mycophenolate.The median time to neutrophil engraftment was 13 days, and the &ldquo;engraftment was really robust,&rdquo; Dr. Srour said during his presentation at SOHO.occurred in 4% of patients in the first 180 days, while moderate-to-severe chronic GVHD occurred in 5% of patients through the first year. The nonrelapse mortality rate was 4% through the first year. Patients receiving Orca-T had a GVHD-free relapse-free survival rate of 71%.&ldquo;We achieved excellent outcomes regarding the graft-versus-host and relapse [rates],&rdquo; Dr. Srour said.The overall survival rate was 90% at 1 year, which is &ldquo;amazing in the transplant field,&rdquo; Dr. Srour said. &ldquo;Your patients are happy at 1 year, back to doing whatever they want to do in their life.&rdquo;Researchers are currently enrolling patients for a multicenter randomized-control phase III trial comparing Orca-T with standard-of-care therapy, he said.&ldquo;I believe this will be practice-changing in a few years. Hopefully we can get [United States Food and Drug Administration] approval if we can prove it,&rdquo; he concluded.Meyer E, Pavlova A, Gandhi A, et al. Orca-T, a precision engineered allograft, results in high GVHD-free and relapse-free survival following myeloablative conditioning for hematological malignancies. Oral abstract CT-524. Presented at the Tenth Annual Meeting of the Society of Hematologic Oncology; September 28-October 1, 2022; Houston, TX.

High GVHD-Free Rates With Orca-T

Conferences

While rates of GVHD after allogeneic HSCT “remain unacceptably high” in many settings, GVHD rates were around 5% in patients receiving Orca-T.