\n\u201cWhile we did not observe improvements in Day 29 outcomes, itolizumab demonstrated compelling clinical results in several important longer-term outcomes, conferring potential patient benefit where there are no approved therapies,\u201d said Bruce Steel, chief executive officer at Equillium. \u201cBased on these data and prior FDA guidance, we have filed for Breakthrough Therapy designation and have been granted a meeting to discuss the potential for Accelerated Approval of itolizumab for first-line treatment of aGVHD, a rare disease where one-year mortality exceeds 40 percent and itolizumab has already received Orphan Drug and Fast Track designations. We expect feedback from the FDA during May and, if positive, we would plan to submit a biologics license application during the first half of 2026.\u201d\n<\/p>\n
\n\u201cThe longer-term outcomes are important,\u201d said Dr. John Koreth, Professor of Medicine, Dana-Farber Cancer Institute, Harvard Medical School. \u201cThere are no approvals in first-line therapy for aGVHD, and no drug candidates have been able to demonstrate efficacy beyond four weeks. To demonstrate statistical significance in pre-specified endpoints of duration of complete response and failure-free survival, compared to standard of care therapy, is clinically meaningful.\u201d\n<\/p>\n
\nThe Phase 3 EQUATOR study in first-line aGVHD demonstrated a favorable safety and tolerability profile, and clinically meaningful longer-term outcomes. There was no meaningful difference in CR or ORR, the primary endpoint and a key secondary endpoint of the study (respectively), at Day 29 between patients treated with itolizumab and placebo, but statistical significance was achieved in several critically important secondary endpoints demonstrating improvement in longer term outcomes:\n<\/p>\n
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- \nStatistical significance in duration of CR favoring itolizumab, with a median 336 days vs. 72 days, p-value 0.017.\n<\/li>\n
- \nStatistical significance in failure-free survival favoring itolizumab, with a median 154 vs. 70 days, p-value 0.043.\n<\/li>\n
- \nStatistical significance in complete response at Day 99 favoring itolizumab, with 35 (44.9%) vs. 22 (28.6%) patients, p-value 0.035.\n<\/li>\n
- \nPositive trend in overall survival favoring itolizumab, with mortality of 19 (24.4%) vs. 25 (32.5%) patients.\n<\/li>\n
- \nSteroid tapering and rates of primary disease relapse and chronic GVHD were similar for both treatment arms.\n<\/li>\n<\/ul>\n
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