Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced new preclinical data showing the activity of IPI-145, its oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in models of diffuse large B-cell lymphoma (DLBCL) and T-cell acute lymphoblastic leukemia (T-ALL), two difficult-to-treat hematologic malignancies (blood cancers) for which limited treatment options are available. Additionally, Phase 1 clinical data of IPI-145 in 14 patients with advanced aggressive non-Hodgkin lymphoma (aNHL) were reported, with early clinical activity observed in patients with DLBCL, Richter transformation and transformed follicular lymphoma. These findings were presented today at the 55th Annual Meeting of the American Society of Hematology (ASH).
“The preclinical data reported today, as well as early clinical data in aggressive non-Hodgkin lymphoma, further underscore the potential of IPI-145 to treat a broad range of blood cancers,” stated Julian Adams, Ph.D., president of R&D at Infinity. “IPI-145 has already shown clinical activity in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia, and we are advancing IPI-145 in late-stage development in these two indications. The preclinical data reported today are expanding our understanding of the mechanism of action of IPI-145 and the roles of PI3K-delta and PI3K-gamma, which will help inform further clinical development.”
Early Clinical Data in aNHL and Preclinical Data in DLBCL
Early Phase 1 data in aNHL and preclinical data in DLBCL were reported in the presentation “The potent PI3K-delta,gamma inhibitor, IPI-145, exhibits differential activity in diffuse large B-cell lymphoma (DLBCL) cell lines” (Abstract #1832). Phase 1 data in 14 patients with aNHL showed that IPI-145 led to a reduction in adenopathy (decrease in the size of lymph nodes) in three of eight patients with DLBCL and two of three patients with Richter transformation. A partial response in one of three patients with transformed follicular lymphoma was also reported. 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 in these patients were neutropenia (32 percent), febrile neutropenia, diarrhea, fatigue, pneumonia, increased ALT/AST (two liver enzymes) and dyspnea (9 percent each).