Infinity Announces Phase I Data from IPI-145 Against R/R Lymphomas

At the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, Infinity Pharmaceuticals announced updated Phase 1 data from an ongoing study of IPI-145, the company's potent oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients diagnosed with relapsed or refractory B-cell or T-cell non-Hodgkin's lymphoma as well as Hodgkin's lymphoma.

Preliminary data indicates that IPI-145 is both well-tolerated and clinically active in patients with subtypes including some indolent non-Hodgkin's lymphomas, T-cell lymphoma, mantle cell lymphoma (MCL) and Hodgkin's lymphoma (HL).

Said trial investigator Steven Horwitz, MD, assistant attending physician in the department of medicine at the Memorial Sloan-Kettering Cancer Center:

I’m encouraged by the early data seen in this Phase 1 study of IPI-145. So far, IPI-145 appears to be well tolerated, with responses seen across a broad range of B-cell and T-cell lymphomas. Many hematologic malignancies are difficult to treat and new agents are clearly needed. Targeted therapies, including IPI-145, have the potential not only to add therapeutic options for our patients but also to reduce or delay the need for chemotherapy, possibly changing the way many of these malignancies are treated.

It wasn't Infinity's only presentation. The company also announced that that its Phase 2 study of IPI-145 in hematologic malignancies is open for enrollment. This trial will be a Phase 2, open-label, single-arm study designed to evaluate the safety and efficacy of IPI-145. They are looking to enroll 120 patients with refractory indolent non-Hodgkin's lymphomas, since data from the Phase 1 study showed that 13 of 19 patients with indolent NHLs had responses to IPI-145, including three who had complete responses.

Said Julian Adams, PhD, president of research and development at Infinity:

Infinity is pleased to begin its first Phase 2 study of IPI-145 in patients with indolent non-Hodgkin lymphoma, which is supported by the early, encouraging, data from our ongoing Phase 1 study reported today at ASCO. Infinity believes IPI-145 has the potential to be the best-in-class PI3K inhibitor for the treatment of blood cancers, and we are rapidly advancing IPI-145 in the clinic with a goal of addressing significant medical needs.

Source: ASCO '13