Dr. Rosenblatt on the DUO Trial in Relapsed/Refractory CLL

Joseph D. Rosenblatt, MD
Published: Friday, Mar 15, 2019



Joseph D. Rosenblatt, MD, professor, associate director for faculty development, University of Miami, Sylvester Comprehensive Cancer Center, discusses the phase III DUO trial in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).

The phase III DUO trial randomized patients with relapsed/refractory CLL to single-agent duvelisib (Copiktra) or ofatumumab (Arzerra) monotherapy, an anti–CD20 antibody that has been approved for patients with refractory CLL for several years, explains Rosenblatt. Patients enrolled in the trial were heavily pretreated, adds Rosenblatt, with poor prognostic indicators such as p53 and 17p deletion.

The multicenter trial showed a significant survival benefit for patients who received the PI3K inhibitor, says Rosenblatt. Results indicated a 60% reduction in the risk of disease progression or death with duvelisib versus ofatumumab as well as a median progression-free survival of 16.4 months with duvelisib versus 9.1 months with ofatumumab. These results served as the basis for the September 2018 FDA approval of duvelisib for the treatment of patients with relapsed/refractory CLL or relapsed/refractory follicular lymphoma following at least 2 prior therapies.
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Joseph D. Rosenblatt, MD, professor, associate director for faculty development, University of Miami, Sylvester Comprehensive Cancer Center, discusses the phase III DUO trial in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).

The phase III DUO trial randomized patients with relapsed/refractory CLL to single-agent duvelisib (Copiktra) or ofatumumab (Arzerra) monotherapy, an anti–CD20 antibody that has been approved for patients with refractory CLL for several years, explains Rosenblatt. Patients enrolled in the trial were heavily pretreated, adds Rosenblatt, with poor prognostic indicators such as p53 and 17p deletion.

The multicenter trial showed a significant survival benefit for patients who received the PI3K inhibitor, says Rosenblatt. Results indicated a 60% reduction in the risk of disease progression or death with duvelisib versus ofatumumab as well as a median progression-free survival of 16.4 months with duvelisib versus 9.1 months with ofatumumab. These results served as the basis for the September 2018 FDA approval of duvelisib for the treatment of patients with relapsed/refractory CLL or relapsed/refractory follicular lymphoma following at least 2 prior therapies.



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