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Abatacept, PTCy, and bortezomib combination for GvHD prophylaxis
Calcineurin inhibitors remain a major part of prophylaxis for GvHD. However, CNIs can be associated with significant toxicity and nonadherence with treatment. A previous study has shown that use of a CNI-free GvHD prophylactic treatment regimen is feasible when combining PTCy and bortezomib (Cybor). Following this study, a phase I/II trial (NCT05289167) was initiated to assess the feasibility of using the Cybor regimen, in combination with abatacept, for GvHD prophylaxis in patients with hematologic malignancies undergoing peripheral blood allo-HSCT. Interim results from the study, with data from the first 25 patients, were presented by Stephanie Boisclair at the 51st Annual Meeting of the EBMT.
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Key learnings |
| Patients were followed up for a median of 18.5 months. Median neutrophil and platelet engraftment times were 17 days and 25.5 days, respectively. No primary graft failures were reported. |
| Two patients experienced Grade 2 aGvHD (at Days +118 and +238), and no Grade 3–4 aGvHD events occurred. Three patients had cGvHD events, with two patients requiring treatment with systemic therapy. The cumulative incidence of 1-year severe cGvHD was 8.17% (95% CI 1.3–23.3%, onset Days +97 and +360). |
| Median relapse-free survival, overall survival, and GvHD and relapse-free survival were not reached. At the time of data cutoff, four patients had experienced relapse in a median time of 281.5 days (two morphological, one cytogenetic, and one molecular relapse), and four deaths occurred. |
| The initial data from this study suggest that using abatacept, PTCy, and bortezomib for GvHD prophylaxis after allo-HSCT can be a viable and effective alternative to CNI-based regimens. The study is ongoing with an additional 20 patients enrolled. |
Abbreviations: aGvHD, acute graft-versus-host disease; allo-HSCT, allogeneic hematopoietic stem cell transplant; cGvHD, chronic graft-versus-host disease; CNI, calcineurin inhibitor; GvHD, graft-versus-host disease; PTCy, post-transplant cyclophosphamide.
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