Equillium, Inc. announced on March 27, 2025, that its Phase 3 EQUATOR study evaluating itolizumab in first-line acute graft-versus-host disease (aGVHD) did not meet its primary endpoint. The study did not demonstrate a meaningful difference in complete response (CR) or overall response rate (ORR) at Day 29 between itolizumab and placebo groups.
Despite missing the primary endpoint, itolizumab achieved statistical significance in several pre-specified secondary endpoints demonstrating clinically meaningful longer-term outcomes. These included complete response at Day 99 (44.9% vs 28.6% for placebo, p=0.035), duration of complete response (median 336 days vs 72 days, p=0.017), and failure-free survival (39.5% at Day 365 vs 22.9%, p=0.043).
The safety profile of itolizumab in the EQUATOR study was consistent with previous findings, showing a favorable tolerability profile without increasing the risk of infection or sepsis. Equillium has filed for Breakthrough Therapy designation and requested a meeting with the FDA to discuss potential Accelerated Approval based on these data, with feedback expected in May 2025.
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