Duvelisib (1) – Copiktra®

• Clinical trials
  • The pharmaceutical manufacturer submitted the randomised, open-label, actively controlled Phase III DUO trial, which compared duvelisib with ofatumumab in patients with CLL and small lymphocytic lymphoma (Small Lymphocytic Lymphoma [SLL]) whose disease is refractory following at least one prior course of treatment for benefit assessment.

a) Adult patients with previously treated CLL who have not yet received a BTK inhibitor and/or a BCL2 inhibitor

• An additional benefit is not proven.

b) Adult patients with CLL who have relapsed or become refractory following prior treatment with at least one BTK inhibitor

• An additional benefit is not proven.

c) Adult patients with CLL who have relapsed or are refractory following prior treatment with at least one BCL2 inhibitor

• An additional benefit is not proven.

d) Adult patients with CLL who have relapsed or are refractory following prior treatment with at least one BTK inhibitor and one BCL2 inhibitor

• An additional benefit is not proven.
• All patients in the control arm of the study were treated with ofatumumab.
• Ofatumumab does not currently have marketing authorisation for the treatment of CLL.
• The active ingredient does not constitute the appropriate comparator therapy for any of the patient groups mentioned.
• Consequently, there are no suitable data available for benefit assessment of duvelisib compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.