Infinity is currently enrolling patients in DYNAMO, a Phase 2 study evaluating the safety and efficacy of IPI-145 in approximately 120 patients with refractory iNHL whose disease is refractory to radioimmunotherapy or to both rituximab and chemotherapy and who have progressed within six months of receiving their last therapy. The primary endpoint of the study is response rate according to the International Working Group (IWG) criteria. 1
Updated Phase 1 Data in Patients with iNHL
Updated Phase 1 data in 15 patients with relapsed/refractory iNHL who received IPI-145 at doses ≤ 25 mg BID were included in a poster presentation, “Treatment with the potent PI3K-delta,gamma inhibitor, IPI-145, is associated with rapid decreases in specific cytokines, chemokines and matrix metalloproteinases in the serum of patients with chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma” (Abstract #1633).
Data showed that IPI-145 was clinically active, with a 73 percent overall response rate (11 of 15 evaluable patients) and a 20 percent complete response rate (3 of 15 patients). Eight patients (53 percent) remain progression-free for over one year.
IPI-145 was generally well tolerated, and the majority of side effects were low-grade, asymptomatic and transient. The most common ≥ Grade 3 side effects were increases in ALT or AST (two liver enzymes) (38 percent), neutropenia (31 percent) and diarrhea (13 percent).
Translational Data in iNHL and CLL
Additionally, researchers today presented new translational data supporting the rationale for studying IPI-145 in both iNHL and CLL (Abstract #1633). Pharmacodynamic data evaluating serum cytokines, chemokines and metalloproteinases (molecules known to play key roles in the interaction between malignant B-cells and the surrounding microenvironment) showed that IPI-145 rapidly decreased the levels of several of these molecules in the serum of both iNHL and CLL patients. These data provide a potential mechanistic rationale for the clinical activity of IPI-145 observed in both iNHL and CLL and support the use of the 25 mg BID dose in clinical studies in both iNHL and CLL.