At the Transplantation & Cellular Therapy 2022 Tandem Meetings, researchers presented data from the phase Ib/II EQUATE trial on intravenous (IV) itolizumab in patients with newly diagnosed acute graft-versus-host disease (aGVHD).
This year, the team presented the final results of the EQUATE trial in a live talk by John Koreth of the Dana-Farber Cancer Institute.
The EQUATE trial enrolled 30 adults with either grade III-IV aGVHD or with grade II aGVHD and an Ann Arbor score of 2-3. All participants received corticosteroids (CS), and all received IV itolizumab within 7 days of initiation of CS. Participants were followed for up to 1 year.
All participants experienced at least 1 adverse event (AE), and 19 had serious AEs. For 11, the AE led to death, but these AEs were not attributed to itolizumab.
The highest overall response rate was seen on day 29 for those who received a dose of 1.6 mg/kg (78%).
Median progression-free survival was 3.6 months at a dose of 0.4 mg/kg, 9.4 months at a dose of 0.8 mg/kg, and 3.7 months for those who received 1.6 mg/kg.
After reviewing the final study data, the authors concluded that “The data from EQUATE continue to demonstrate promising outcomes in subjects with severe aGVHD. Day 29 response was consistent with progression free survival and previous PK/PD/response relationships. Based on these data, an itolizumab dosing regimen of an initial dose of 1.6 mg/kg followed by 6 0.8 mg/kg doses q2w is being evaluated in a Phase 3 study (EQUATOR, NCT05263999) as initial therapy for aGVHD in combination with CS.”
Koreth J, Loren AW, Nakamura R, et al. Final Safety and Efficacy Results from Equate, an Open-Label Study Evaluating Itolizumab, a Novel Targeted Anti-CD6 Therapy, in Newly Diagnosed Acute Graft-Versus-Host Disease. Abstract #36. Presented at the 2023 Tandem Meetings of ASTCT and CIBMTR; February 15-19, 2023; Orlando, FL.