Researchers evaluated mocravimod, an oral sphingosine-1-phosphate receptor (S1PR) modulator, in patients undergoing allogeneic hematopoietic cell transplant (allo-HCT). They suggested mocravimod was safe, and their efficacy data supported larger studies to further explore mocravimod in this population. The study was published in Transplantation and Cellular Therapy.
The authors explained that, unlike immunosuppressants, mocravimod selectively blocks the signal required by T cells in lymph nodes and other organs to activate, which may improve survival by maintaining graft-versus-leukemia activity while reducing incidence of graft-versus-host disease (GVHD).
Mocravimod Shows Potential in GVHD Treatment
The study enrolled 23 patients. Of those patients, 10 and 6 received once-daily mocravimod 3 mg or 1 mg, respectively, with cyclosporine A (CsA) and methotrexate, and 7 received mocravimod 3 mg with tacrolimus and methotrexate.
In total, 5 of 23 patients developed grade III-IV acute GVHD (aGVHD) of the lower intestinal tract, liver, or skin. The rate of 1-year aGVHD-free survival was lowest in the tacrolimus arm and highest in the 3 mg dose with CsA arm. The median time to any aGVHD was 54 days (range, 17-102 days) in 3 mg with CsA, 45 days (range, 14-98 days) in the tacrolimus group, and not estimable (range, 22-65 days) in the 1 mg with CsA group, as less than 50% of patients did not have any aGVHD.
A total of 713 adverse events (AEs) were recorded among the 23 subjects. Of these, 47 AEs from 15 patients were serious. Two patients in the 3 mg with CsA group developed bradycardia, a known S1PR modulator-related AE, but did not require dose adjustments. Overall, 7 patients had AEs leading to discontinuation, 4 of which were judged to be mocravimod-related.
“Overall, the results of this small study support further investigations of mocravimod in a larger homogeneous patient population undergoing allo-HSCT to confirm safety and assess clinical efficacy, such as overall survival, relapse-free survival, and GVHD-free survival,” the researchers concluded.
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