Drug updated on 3/28/2024
| Dosage Form | Capsule (oral; 15 mg, 25 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Summary
- Duvelisib (Copiktra) is used 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.
- Three systematic reviews/meta-analyses were reviewed to gather information about this drug's safety and efficacy in treating different types of relapsed or refractory lymphoid neoplasm.
- The pooled overall response rate in CLL/SLL, B-cell indolent non-Hodgkin lymphoma, B-cell aggressive non-Hodgkin lymphoma, and T-cell non-Hodgkin Lymphoma was 70%, 70%, 28% and 47% respectively according to one study included in the review.
- A comparison between duvelisib-treated CLL/SLL patients with TP53 mutation/17p-deletion versus those without these mutations showed no significant difference in their overall response rates - both groups responded similarly well to the treatment.
- In terms of safety outcomes compared against other treatments such as idelalisib, copanlisib, umbralisib etc., duvelisib had a lower relative risk for all grouped adverse events including any grade ≥3 treatment-emergent adverse events; however it achieved similar efficacy outcomes as per another meta-analysis reviewed here.
- Both Ibrutinb monotherapy and Venetoclax rituximab have been found more effective than Copiktra when considering long-term progression-free survival and overall survival among relapse/refractory chronic lympohcytic leukemia patients based on a network meta-analysis that included seven phase III randomized controlled trials involving over two thousand five hundred participants treated with nine regimens including Copiktra.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Copiktra (duvelisib) Prescribing Information. | 2021 | Secura Bio, Inc., Las Vegas, NV |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Chronic lymphocytic leukemia/small lymphocytic lymphoma, version 4.2020. | 2020 | Journal of the National Comprehensive Cancer Network |
| NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) T-cell lymphomas version 2.2022. | 2020 | Journal of the National Comprehensive Cancer Network |