Drug updated on 4/26/2024
| Dosage Form | Injection (intravenous; 60 mg/vial) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Summary
- Copanlisib (Aliqopa) is indicated for treating adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It significantly increases the risk of rash, pruritus, and dry skin compared to control groups in randomized controlled trials.
- Three studies provided a detailed comparison and summary of findings concerning Aliqopa's safety and effectiveness relative to other compounds used in similar patient populations.
- Tazemetostat exhibited a more favorable safety profile than copanlisib, showing a lower relative risk for all grouped safety outcomes, including any grade ≥3 Treatment-Emergent Adverse Events (TEAEs).
- When used in combination with rituximab, copanlisib displayed slight differences in specific adverse events such as hyperglycemia, hypertension, and fatigue. This suggests that combining these two might influence their overall safety profile.
- Regarding efficacy among PI3K inhibitors such as idelalisib, duvelisib, umbralisib, etc., tazemetostat achieves similar efficacy outcomes, suggesting comparable effectiveness despite differing safety profiles. Furthermore, when used with rituximab for R/R B-NHL treatment, including indolent forms of B-NHL, copanlisib demonstrated superior efficacy, notably higher complete response rate (CR) and objective response rate (ORR).
- Subgroup analyses revealed significant associations between all-grade rash and cancer types with PI3K inhibitor assignments, emphasizing the importance of considering patient characteristics while evaluating risks. Additionally, the only study involving patients with grade 3b or transformed FL was for tazemetostat, indicating its wider application potential across different FL subtypes not specifically targeted by the discussed PI3K inhibitors.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Aliqopa (copanlisib) Prescribing Information. | 2023 | Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Newly diagnosed and relapsed follicular lymphoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2021 | Annals of Oncology |
| NCCN guidelines insights: B-Cell lymphomas, version 3.2019. | 2019 | Journal of the National Comprehensive Cancer Network |