Copanlisib

(Aliqopa®)

Aliqopa®

Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 60 mg/vial)
Drug ClassKinase 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.

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Summary
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  • Copanlisib (Aliqopa) is indicated for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. It significantly increases the risk of cutaneous adverse effects such as all-grade rash, high-grade rash, serious rash events, pruritus, and dry skin compared to control arms in PI3K inhibitor treatments.
  • Three studies showed that Aliqopa has higher relative risks for grade ≥3 treatment-emergent adverse events compared to Tazemetostat. Patients treated with Tazemetostat exhibited lower risks for grouped safety outcomes including serious TEAEs and any TEAE leading to dose reduction or drug discontinuation.
  • In patients with relapsed/refractory B-cell Non-Hodgkin Lymphoma (B-NHL), Aliqopa demonstrated a high incidence of any grade AEs and grade ≥3 AEs. Common AEs included hyperglycemia, hypertension, diarrhea, nausea, and fatigue, with hyperglycemia and hypertension being particularly notable for their severity.
  • The efficacy profile comparison indicates that Aliqopa achieved similar efficacy outcomes to Tazemetostat and other PI3K inhibitors in terms of objective response rates but direct comparisons suggested parity more than superiority.
  • As both monotherapy or in combination with rituximab, it shows satisfactory efficacy in patients with R/R B-NHL. Combination therapy demonstrated superior efficacy compared to monotherapy suggesting its effectiveness when used alongside other medications like rituximab especially within the indolent B-NHL patient population.
  • Across varying population subsets including different types of B-cell non-Hodgkin lymphoma cases, it was found effective though combination therapy was notably more effective within specific subgroups indicating potential gaps regarding comparative data on FL subgroups related specifically to this drug's usage.