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Vedolizumab Tolerable for Prevention of GVHD in Patients Undergoing Allo-HSCT
Study findings showed that vedolizumab 300 mg was tolerable for the prevention of acute graft-versus-host disease (aGVHD) and led to low incidence of overall and lower-intestinal aGVHD in patients who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT; Blood Adv. 2019;3[23]:4136-4146).
“Vedolizumab could help prevent aGVHD by inhibiting the migration of both naive and activated lymphocytes into gut-associated lymphoid tissues and the lamina propria,” posited Yi-Bin Chen, MD, Massachusetts General Hospital, Boston, and colleagues, who conducted a phase 1b, open-label, dose-finding study to determine the drug’s efficacy in reducing aGVHD in adults undergoing allo-HSCT. They also sought to evaluate the safety, tolerability, and pharmacokinetics of vedolizumab.
Overall, 24 adults were enrolled in the study and given intravenous (IV) vedolizumab on days −1, +13, and +42 with respect to allo-HSCT, starting at 75 mg and with dose escalation guided by tolerability and pharmacokinetics.
There were no dose-limiting toxicities observed in the 3 patients in the 75-mg cohort or among the 21 patients in the dose-escalated 300-mg cohort. Dr Chen and co-investigators reported 4 deaths and the occurrence of treatment-emergent adverse events in 8 patients during the 12 months following allo-HSCT.
Within 100 days of undergoing allo-HSCT, no patients in the 75-mg cohort had modified Glucksberg grade II to IV aGVHD, and 4 (19.0%) patients in the 300-mg cohort had grade II to IV aGVHD, including 3 cases of stage I aGVHD of the lower-intestinal tract.
“The results from this study support further evaluation of vedolizumab IV 300 mg added to standard GVHD prophylaxis in patients undergoing allo-HSCT, and a phase 3 randomized study (#NCT03657160) is ongoing,” Dr Chen and colleagues concluded.—Hina Porcelli
