Popat Covers Itacitinib and GVHD Prevention Trial Results

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Uday R. Popat, MD, discusses promising findings from a phase 2 trial evaluating the JAK inhibitor itacitinib combined with post-transplant cyclophosphamide and tacrolimus for graft-vs-host disease prevention.

Uday R. Popat, MD, professor of medicine in the Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, discusses promising findings from a phase 2 trial evaluating the JAK inhibitor itacitinib (INCB039110) combined with post-transplant cyclophosphamide (PTCy) and tacrolimus for graft-vs-host disease (GVHD) prevention in patients undergoing a myeloablative fractionated busulfan regimen.

According to findings presented at the 2025 Transplant and Cellular Therapy Meetings, a total of 31 patients with a median age of 62 (range, 25-69) years were enrolled. Ten (32%) patients had acute myeloid leukemia, 10 (32%) had myelofibrosis, 6 (19%) had myelodysplastic syndrome, and 1 each had chronic lymphocytic leukemia, lymphoma, chronic myeloid leukemia, myeloma, and acute lymphoblastic leukemia.

At day 100, the cumulative incidence of grade 2, 3, or 4 acute GVHD was 26% (10%-42%), and was seen in 8 patients. Moderate to severe chronic GVHD was observed in 4.5% of patients, and there were no deaths related to GVHD.

At a median follow up of 18 months, the 1-year overall survival, progression-free survival, GVHD-free relapse free survival, non-relapse mortality, and relapse rates were 81%, 81%, 70%, 16%, and 3.2% respectively. These results suggest effective GVHD control without compromising anti-leukemic efficacy, particularly in older patients.

“This is a trial where we enrolled patients between 18 and 70, so this is a reasonably older group of patients. Our median age was 62, ranging between 25 and 69. What we saw here was 1-year survival of 80%, which was pretty decent.”

REFERENCE:
Popat UR, Alousi AM, Bassett RL, et al. JAK inhibitor itacitinib with PTCY and tacrolimus to prevent GVHD in a myeloablative fractionated busulfan regimen: A phase 2 trial. Presented at: 2025 Transplant and Cellular Therapy Meetings; February 12-15, 2025; Honolulu, HI. Abstract 37.

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