Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced Phase 1 data from an ongoing study of IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma in patients with advanced hematologic malignancies, or potentially fatal blood cancers. Data from the study showed that IPI-145 was well tolerated and clinically active across a broad range of blood cancers, including indolent non-Hodgkin lymphoma (iNHL), chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Hodgkin lymphoma (HL) and T-cell lymphomas. These findings were reported in three presentations during the 12 th International Conference on Malignant Lymphoma (ICML) held from June 19 – 22, 2013, in Lugano, Switzerland.
“These early data show that IPI-145 is well tolerated and clinically active in patients with B-cell or T-cell malignancies, with a median time to response of less than two months,” commented Ian Flinn, M.D., Ph.D., director, hematologic malignancies program, Sarah Cannon Research Institute, and an investigator for the trial. “Many of these hematologic malignancies are difficult to treat, and new treatment options for patients are clearly needed. Investigational medicines in development, such as IPI-145, are exciting because they offer a targeted approach and have the potential to reduce or delay the need for chemotherapy.”
“We hope the rapid onset of activity observed with IPI-145 across a broad range of hematologic malignancies will translate into a meaningful clinical benefit for patients,” stated Pedro Santabarbara, M.D., chief medical officer at Infinity. “Infinity is committed to rapidly advancing IPI-145 in the clinic with a goal of developing the best-in-class PI3K inhibitor for the treatment of hematologic malignancies. Earlier this month, we announced the initiation of a Phase 2 trial of IPI-145 in patients with refractory iNHL, and we expect to begin our next trial in patients with blood cancers later this year.”
On June 3, 2013, Infinity announced the initiation of a Phase 2, open-label, single-arm study designed to evaluate the safety and efficacy of IPI-145 dosed at 25 mg twice daily (BID) in approximately 120 patients with iNHL (follicular lymphoma, marginal zone lymphoma or small lymphocytic lymphoma) whose disease is refractory to both rituximab and chemotherapy or radioimmunotherapy. The primary endpoint of the study is response rate according to the International Working Group Criteria. 1 In June, Infinity reported data from its ongoing Phase 1 study showing a 68 percent response rate in patients with iNHL, which included three complete responses (CRs) and 10 partial responses (PRs) among the 19 patients evaluable for response.“The early Phase 1 data of IPI-145 in patients with iNHL are exciting, and we believe IPI-145 has the potential to become the best-in-class PI3K inhibitor in this indication,” stated Julian Adams, Ph.D., president of research and development at Infinity. “Infinity has therefore moved quickly into Phase 2 development to evaluate IPI-145 dosed at 25 mg twice daily in patients with refractory iNHL. In the Phase 1 study, this dose showed rapid, robust clinical activity and demonstrated complete inhibition of PI3K-delta and at least 50 percent inhibition of PI3K-gamma.”