Duvelisib

(Copiktra®)

Copiktra®

Drug updated on 9/4/2024

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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  • Copiktra (duvelisib) is 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.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Duvelisib Effectiveness Across Lymphoid Neoplasms: The pooled overall response rate (ORR) varied significantly among different lymphoid neoplasm types: CLL/SLL (70%), B-cell indolent NHL (70%), B-cell aggressive NHL (28%), and T-cell NHL (47%). Notable differences were observed in specific subgroups, such as Mantle Cell Lymphoma (68% vs. 17%, p=0.04) and Angioimmunoblastic TCL (67% vs. 42%, p=0.01).
  • Network Meta-Analysis in Relapsed/Refractory CLL: Venetoclax plus rituximab and ibrutinib monotherapy showed significantly better progression-free survival (PFS) and overall survival (OS) compared to ofatumumab in relapsed/refractory CLL. For PFS, HR for ibrutinib was 0.10 (95% CI, 0.07-0.14) and for venetoclax plus rituximab was 0.10 (95% CI, 0.05-0.21). For OS, HR for ibrutinib was 0.361 (95% CI, 0.208-0.627) and for venetoclax plus rituximab was 0.335 (95% CI, 0.112-0.997).
  • Comparison with Tazemetostat: ORR was not significantly different between tazemetostat and other drugs like idelalisib (43% vs. 56%, p=0.16), duvelisib (48% vs. 47%, p=0.91), copanlisib (49% vs. 61%, p=0.11), and umbralisib (57% vs. 47%, p=0.10).
  • Duvelisib demonstrated a high incidence of adverse events, with 99% of patients experiencing any grade AEs, 79% experiencing grade ≥3 AEs, 63% experiencing serious AEs, 33% discontinuing treatment due to AEs, and 3% experiencing treatment-related death.
  • The most common any-grade AEs with duvelisib were diarrhea (47%), ALT/AST increase (39%), and neutropenia (38%), while the most frequent grade ≥3 AEs were neutropenia (25%), ALT/AST increase (16%), diarrhea (12%), and anemia (12%).
  • The population types and subgroups considered include relapsed/refractory lymphoid neoplasm types such as CLL/SLL, iNHL, aNHL, and T-NHL, with specific focus on genetic subgroups like CLL/SLL with or without TP53 mutation/17p-deletion, FL vs. other iNHL, MCL vs. other aNHL, and AITL vs. other PTCL, highlighting significant differences in ORR for MCL vs. other aNHL and AITL vs. other PTCL, but no significant differences for CLL/SLL patients with or without TP53 mutation/17p-deletion and FL vs. other iNHL.