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Add-on parsaclisib for patients with myelofibrosis and suboptimal response to ruxolitinib: a randomized phase 3 study - PubMed

3 hours ago
  • #Myelofibrosis
  • #Clinical trial
  • #PI3K inhibitor
  • The LIMBER-304 study investigated adding parsaclisib, a PI3Kδ inhibitor, to ruxolitinib for myelofibrosis patients with suboptimal response.
  • At Week 24, 16.7% of patients on parsaclisib/ruxolitinib achieved ≥25% spleen volume reduction vs. 9.7% on placebo/ruxolitinib, but this was not statistically significant.
  • Symptom reduction (≥50% MFSAF-TSS) was similar between groups: 17.1% with add-on parsaclisib vs. 14.1% with placebo.
  • Higher rates of infections and gastrointestinal disorders occurred with parsaclisib/ruxolitinib, and Grade ≥3 adverse events were more frequent (60.0% vs. 42.5%).
  • The study was terminated early, concluding that add-on parsaclisib likely does not provide clinically meaningful benefits over ruxolitinib alone.