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Copanlisib

(Aliqopa®)

Aliqopa®

Drug updated on 9/4/2024

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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  • Aliqopa (copanlisib) is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • The overall response rate (ORR) for copanlisib in relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients was 57%, with a complete response rate (CR) of 13% and a partial response rate (PR) of 40%. The disease control rate (DCR) was 86%, with 19% achieving stable disease (SDR) and 9% showing progressive disease (PDR).
  • In patients with relapsed/refractory indolent B-NHL, combination therapy of copanlisib with rituximab significantly improved outcomes compared to copanlisib monotherapy, with a CR of 34% vs. 7% (p<0.01) and an ORR of 92% vs. 58% (p<0.01).
  • An indirect comparison between copanlisib and tazemetostat showed no significant difference in the overall response rate (ORR) between the two, with copanlisib at 61% and tazemetostat at 49% (p=0.11).
  • General Safety Profile of Copanlisib: A high incidence of adverse events (AEs) was observed, with 99% for monotherapy and 96% for combination therapy. Grade ≥3 AEs occurred in 84% of monotherapy patients and 91% of combination therapy patients. Common any grade AEs included hyperglycemia (66.75%), hypertension (48.57%), diarrhea (35.06%), nausea (34.98%), and fatigue (30.33%). Grade ≥3 AEs included hyperglycemia (45.14%), hypertension (35.07%), and neutropenia (14.75%).
  • Specific Safety Concerns: Copanlisib was associated with significant cutaneous adverse events, including all-grade rash (RR 2.29, 95% CI 1.58-3.31, p<0.00001), high-grade rash (RR 9.34, 95% CI 4.21-20.69, p<0.00001), and serious rash events (RR 5.11, 95% CI 2.11-12.36, p=0.0003). Other noted concerns were pruritus (RR 1.63, 95% CI 1.14-2.33, p=0.007) and dry skin (RR 3.34, 95% CI 2.30-4.85, p<0.00001).
  • There is no population types or subgroups information available in the reviewed studies.