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Duvelisib

(Copiktra®)

Copiktra®

Drug updated on 10/29/2024

Dosage FormCapsule (oral; 15 mg, 25 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Duvelisib demonstrated an overall response rate (ORR) of 70% in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and B-cell indolent non-Hodgkin lymphoma (iNHL), while patients with B-cell aggressive non-Hodgkin lymphoma (aNHL) had an ORR of 28% and T-cell non-Hodgkin lymphoma (T-NHL) had an ORR of 47%.
  • In subgroup analysis, mantle cell lymphoma (MCL) had a significantly higher ORR compared to other aggressive NHL (68% vs. 17%, p=0.04), and angioimmunoblastic T-cell lymphoma (AITL) showed a significantly higher ORR compared to other peripheral T-cell lymphomas (67% vs. 42%, p=0.01).
  • Comparative effectiveness between duvelisib and other PI3K inhibitors showed no statistically significant differences in ORR between duvelisib (48%) and other agents, such as idelalisib (43%, p=0.16) and copanlisib (49%, p=0.11).
  • Duvelisib was associated with a high incidence of any-grade adverse events (AEs) at 99%, with 79% experiencing grade ≥3 AEs, and 63% reporting serious AEs. The most common any-grade AEs were diarrhea (47%), ALT/AST increase (39%), and neutropenia (38%), while the most frequent grade ≥3 AEs included neutropenia (25%), ALT/AST increase (16%), and diarrhea (12%).
  • The risk of grade ≥3 treatment-emergent adverse events (TEAEs) was lower for tazemetostat compared to duvelisib (RR = 0.35, p < 0.01), idelalisib, copanlisib, and umbralisib.
  • Subgroup analysis showed significant differences in ORR for mantle cell lymphoma (MCL) compared to other aggressive non-Hodgkin lymphomas (68% vs. 17%, p=0.04) and angioimmunoblastic T-cell lymphoma (AITL) compared to other peripheral T-cell lymphomas (67% vs. 42%, p=0.01), while no significant difference in ORR was observed in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with or without TP53 mutation/17p-deletion (62% vs. 74%, p=0.45).