A phase I/II Study of Duvelisib plus Venetoclax in Patients with Relapsed/Refractory CLL/SLL or Richter Transformation - PubMed
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- #Duvelisib
- #CLL/SLL
- #Venetoclax
- Phase I/II study evaluated duvelisib plus venetoclax in relapsed/refractory CLL/SLL and Richter Transformation (RT).
- 44 patients enrolled: 35 with CLL/SLL (77% unmutated IGHV, 46% TP53 aberrancy, median 2 prior therapies) and 9 with RT.
- Recommended phase II dose: duvelisib 25 mg BID plus venetoclax 400 mg daily; maximum tolerated dose not reached.
- Hematologic toxicity: ≥grade 3 neutropenia in 91%, febrile neutropenia in 6%.
- Common non-hematologic toxicities: diarrhea (63%, 14% ≥grade 3), elevated AST (51%, 9% ≥grade 3), nausea (49%, 3% grade 3).
- Response rates: best complete response 60%, overall response 91%; peripheral blood/bone marrow uMRD 43%/40% at cycle 13.
- Median PFS for CLL/SLL patients: 46 months; 3-year PFS 67% (95% CI: 0.51-0.86).
- 4 RT patients responded (3 complete responses).
- Combination active in high-risk R/R CLL/SLL and RT, but serious adverse events, including immune-mediated toxicities, occurred.