Copanlisib plus rituximab versus placebo plus rituximab for relapsed indolent non-Hodgkin lymphoma

Copanlisib is an inhibitor of PI3K, with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B-cells. The multinational phase 3 CHRONOS-3 study randomized patients with relapsed indolent non-Hodgkin lymphoma 2:1 to copanlisib plus rituximab or placebo plus rituximab. The median PFS was 21.5 months in the copanlisib group versus 13.8 months in the placebo group (HR 0.52; p= 0.00002). The safety profile of the combination was manageable and consistent with copanlisib and rituximab as monotherapies.