DYNAMO: A phase 2 trial of the PI3K-δ,γ inhibitor IPI-145 in patients with refractory indolent non-Hodgkin lymphoma.

TPS8619 Background: Phosphoinositide 3-kinase (PI3K)-δ,γ isoforms are preferentially expressed in leukocytes, have significant roles in normal B and T cell function, and are central to the growth and survival of certain B and T cell malignancies. Inhibition of these isoforms by IPI-145, an oral PI3K-δ,γ inhibitor, has unique therapeutic potential in hematologic malignancies. IPI-145 has shown clinical activity and a favorable safety profile across a broad range of hematologic malignancies in an ongoing phase 1 trial (IPI-145-02). Based on these results, the DYNAMO phase 2 trial (IPI-145-06) was initiated in May 2013 to evaluate the efficacy and safety of IPI-145 in patients with indolent non-Hodgkin lymphoma (iNHL) refractory to rituximab and chemotherapy or radioimmunotherapy (RIT). Methods: This open-label, single-arm trial includes adult patients diagnosed with iNHL (defined as follicular lymphoma [FL], marginal zone lymphoma, or small lymphocytic lymphoma) whose disease has progressed within 6 months ...