R/R indolent B-cell lymphoma: durable efficacy, low late-onset toxicity with IV copanlisib

  • Dreyling M & al.
  • Am J Hematol
  • 23 Dec 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Intravenous (IV) copanlisib demonstrated durable efficacy with no new treatment-emergent adverse events and with a low incidence of late-onset toxicities in 2-year follow-up in patients with relapsed/refractory (R/R) indolent B-cell lymphomas.

Why this matters

  • Adverse events (AEs) and late-onset AEs have been associated with some oral agents targeting the phosphatidylinositol-3 kinase (PI3K) pathway.
  • Copanlisib is an IV PI3K inhibitor.

Study design

  • 2-year follow-up of the phase 2 CHRONOS-1 study of IV copanlisib in 142 patients, 141 of whom had indolent B-cell lymphoma; 104 had follicular lymphoma.
  • Patients had received ≥1 year of IV copanlisib.
  • Median patient age at baseline: 63 (range, 25-82) years.
  • Funding: Bayer AG.

Key results

  • At 2 years follow-up vs at primary analysis:
    • 60.6% objective response rate vs 59.2%.
    • 16.9% complete response (CR) vs 11.9%.
    • 54.2% grade 3 AEs vs 52.8%.
    • 28.9% grade 4 AEs vs 26.8%.
    • 55.6% serious AEs vs 50.0%
  • Median duration of response: 14.1 (range, 0.03-42.5) months.
  • Median PFS: 12.5 (range, 0.03-44.2) months.
  • Median OS: 42.6 (range, 0.2-49.9) months.
  • Median duration of copanlisib treatment: 26 (range, 1-192) weeks.

Limitations

  • Open-label study.