Interim Findings from the EQUATE Study Demonstrate Safety and Efficacy of Itolizumab

The following was recently published in ASTCT’s Nucleus publication. Follow @ATSTCT for the latest on all-things cellular therapy.

In a presentation at the 2021 European Hematology Association Virtual Congress, John Koreth, MD, PhD, from the Dana-Farber Cancer Institute highlighted interim findings of the ongoing US-based EQUATE study. In this study, patients diagnosed with graft versus host disease (GVHD) were administered steroids alongside the IgG1 monoclonal antibody itolizumab.

Patients undergoing allogeneic hematopoietic cell transplants are at risk of developing GVHD. The co-stimulatory receptor CD6 is expressed in T cells and exacerbates the immune response driving GVHD, which motivated the researchers to investigate the efficacy of itolizumab at reducing T cell activity by binding to CD6. Ten patients with Grade III-IV acute GVHD (aGVHD) were administered itolizumab within 72 hours following an initial dose of steroids. Itolizumab was administered according to a dose-escalation schedule of 0.4 mg/kg, 0.8 mg/kg, and 1.6 mg/ kg.

The overall response rate, which spanned all doses, was 80%, with a complete response reported by 70% of patients. On Day 85 of the study, a median percentage of 89% was noted for steroid use reduction, and within the first day of administration, CD6 levels in T cells were reduced. Although ongoing, the outcomes of this Phase 1b/2 study demonstrate a promising benefit-risk profile as well as a safety summary in line with other studies of itolizumab.

Reference

Koreth, J., Loren, A. W., Nakamura, R., et al. Interim results from the equate study: Preliminary safety and efficacy of itolizumab, a novel targeted anti-CD6 therapy, newly diagnosed acute graft-versus-host disease. HemaSphere. 2021. 5(SUPPL 2):77-78.