Umbralisib (Ukoniq) – 4L+ FL

Full Efficacy & Safety Summary Table

IndicationPatients with relapsed FL following at least 3 prior lines of therapy
Registrational TrialAccelerated Approval. Phase 2 single arm ULTRA-V trial (n=117) (NCT03801525)
Regimen800 mg orally once daily with food
Efficacy OutcomesORR: 43% / 3.4% CR
DOR: 11.1 mo
Safety OutcomesGrade 3/4 AEs: Neutropenia 18%,  Diarrhea Colitis: 9%,  ALT/AST 9%,  Pneumonia 3%,  Sepsis 2%,  UTI 2%

N=221 patients pooled across trials

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