Efficacy and safety of ifupinostat in relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase 2 study. Download PDF Abstract Ifupinostat (BEBT-908) is a novel dual-targeted inhibitor of histone deacetylase (HDACs) and phosphatidylinositol 3-kinase alpha (PI3Kα). We evaluated the efficacy and safety of ifupinostat monotherapy in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after at least 2 prior lines of systemic therapy.
Eligible participants received intravenous ifupinostat at 22.5 mg/m² on days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. The primary endpoint was objective response rate (ORR) assessed by blinded independent central review (BICR). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety.
From June 2020 to July 2022, 128 patients were enrolled and included in the safety set (SS), and 115 patients were in the efficacy analysis set (EAS). At the data cutoff (July 2023), the median follow-up was 19.58 months (95% confidence interval [CI] 16.82–21.95). The ORR was 36.5% (42/115, 95% CI 27.7-46.0), with a complete response rate of 11.3% (13/115).
Medical Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with qualified healthcare professionals for medical decisions and treatment options.
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