Equillium's Itolizumab Shows Rapid, Durable Responses In Graft-Versus-Host-Disease Patients

Equillium Inc EQ has announced positive topline data from the Phase 1b EQUATE study evaluating itolizumab in first-line acute graft-versus-host-disease (aGVHD).
The results were presented at the European Hematology Association 2021 Virtual Congress.
All patients in the study (N=20) were evaluated as high-risk aGVHD and achieved complete response (CR) and overall response rates (ORR) at Day 29 of 55% and 70%, respectively.
Responses observed were generally rapid – within 15 days – and durable through Day 29 and beyond.
14 patients were characterized as treatment naïve – receiving itolizumab within three days of first steroid administration – and achieved CR and ORR of 64% and 71%, respectively.
Additionally, responding patients experienced clinically meaningful reductions in steroid administration.
Across all dosing cohorts, 60% of patients (12/20) reported serious adverse events, with only 10% (2/20) of these events reported as treatment-related. There were 4 (20%) adverse events that led to death, and none were treatment-related.
Overall survival at month six across all dosing cohorts was 67%.
The optimal dose range observed 0.8 to 1.6 mg/kg; no further dose escalation is anticipated.
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