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A major myelofibrosis trial hits a dead end. The phase 3 IMpactMF trial testing imetelstat in relapsed/refractory myelofibrosis has been discontinued after an independent monitoring committee determined the drug was unlikely to improve overall survival versus best available therapy. No new safety concerns were flagged, and Geron plans to analyze and share the trial data with the scientific community.
A major myelofibrosis trial hits a dead end. Geron Corporation has discontinued its phase 3 IMpactMF trial, which was testing imetelstat (Rytelo) in patients with intermediate-2 or high-risk myelofibrosis that had relapsed or become refractory to a JAK inhibitor. The decision came after an independent data monitoring committee (IDMC) concluded the trial was unlikely to meet its primary endpoint of overall survival (OS) compared to best available therapy (BAT).
The trial, which launched in April 2021, had enrolled 327 patients and was originally expected to reach primary completion in 2028. Patients were randomized 2:1 to receive imetelstat intravenously every 3 weeks or BAT. The IDMC reported no new safety signals beyond imetelstat's known profile. Geron says it will conduct a full data analysis and share findings with the broader scientific community.
By the Numbers:
Why it matters: Relapsed/refractory myelofibrosis after JAK inhibitor failure remains an area with significant unmet need. This setback narrows the treatment pipeline for a difficult-to-treat patient population, though imetelstat retains its FDA approval for low- to intermediate-1-risk myelodysplastic syndromes.
