Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) today announced updated data from a Phase 1 study of IPI-145, its oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with chronic lymphocytic leukemia (CLL), a potentially fatal hematologic malignancy (blood cancer). Data from the study showed that IPI-145 was highly active in patients with relapsed/refractory CLL, with a nodal response rate of 89 percent and an overall response rate of 48 percent as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria 1, including one complete response and 12 partial responses, among patients receiving IPI-145 at doses ≤ 25 mg twice daily (BID). Onset of activity was rapid, with the majority of responses occurring in less than two months. These data, along with safety data showing that IPI-145 was generally well tolerated, support DUO, Infinity’s Phase 3 registration study of IPI-145 in patients with relapsed/refractory CLL, which is now enrolling patients.
Additionally, data from this Phase 1 study showed that IPI-145 is active in other blood cancers, including advanced T-cell lymphomas. Treatment with IPI-145 in patients with T-cell lymphomas led to an overall response rate of 38 percent, including one complete response and nine partial responses. Among the subset of patients with peripheral T-cell lymphoma (PTCL), IPI-145 led to an overall response rate of 50 percent, including one complete response and five partial responses. These Phase 1 data in CLL and T-cell lymphoma, as well as in indolent non-Hodgkin lymphoma (iNHL), were highlighted during the 55th Annual Meeting of the American Society of Hematology (ASH) press program this morning and will be presented by Ian Flinn, M.D., Ph.D., director, hematologic malignancies research, Sarah Cannon Research Institute, and a lead investigator for the Phase 1 trial, on Monday, December 9, 2013, at 5:30 p.m. CT (6:30 p.m. ET) in Room 295-296 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.