- 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.
- 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.
- 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.
- Open-label study.