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Exploratory biomarker analysis from a phase III study of the PI3K inhibitor, copanlisib, in combination with rituximab in patients with indolent non-Hodgkin lymphoma, a retrospective study.

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Area of Science:

  • Oncology
  • Pharmacology
  • Hematology

Background:

  • Copanlisib is an intravenous phosphatidylinositol 3-kinase (PI3K) inhibitor used for relapsed follicular lymphoma.
  • Concerns exist regarding the tolerability and dose optimization of PI3K inhibitors in hematological malignancies.
  • The current dosing regimen of copanlisib was established as the maximal tolerated dose (MTD) in Phase I trials.

Purpose of the Study:

  • To justify the selected dosing regimen of copanlisib.
  • To evaluate the exposure-efficacy and exposure-safety relationships of copanlisib.

Main Methods:

  • Exposure-efficacy analysis utilized data from the Phase III CHRONOS-3 trial.
  • Exposure-safety analysis pooled data from two large clinical trials.
  • A model-based benefit/risk framework assessed the appropriateness of the dosing regimen.

Main Results:

  • A significant positive linear relationship was observed between copanlisib exposure and efficacy at the MTD.
  • A borderline significant linear relationship was found between exposure and grade ≥3 treatment-emergent adverse events (TEAEs).
  • No significant exposure-safety relationships were identified for other safety endpoints.

Conclusions:

  • The established dosing regimen for copanlisib is appropriate across achieved exposure ranges.
  • The benefit-risk profile supports the current dosing strategy for copanlisib in relapsed follicular lymphoma.