Date: 2014-11-06
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the American Society of Hematology (ASH) 2014 Annual Meeting, which is being held December 6-9 in San Francisco, CA
Company: Infinity Pharmaceuticals (USA - MA)
Product: duvelisib (IPI-145)
Action
mechanism: phosphoinositide 3-kinase (PI3K) inhibitor. Duvelisib is an oral inhibitor of Class I PI3K-delta,gamma. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity. The PI3K-delta,gamma isoforms are preferentially expressed in leukocytes (white blood cells), where they have distinct and mostly non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of hematologic malignancies. Infinity and AbbVie Inc. are developing duvelisib, an oral inhibitor of Class I PI3K-delta,gamma. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity. The Class 1 PI3K-delta and PI3K-gamma isoforms are preferentially expressed in leukocytes, or white blood cells, where they have distinct and predominantly non-overlapping roles in key cellular functions, including cell proliferation, cell differentiation, cell migration and activation. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of hematologic malignancies. In 2013, Infinity launched the DUETTS™ (Duvelisib Trials in Hematologic Malignancies) program, a worldwide investigation of duvelisib in blood cancers. As part of the DUETTS program, patient enrollment is ongoing in DYNAMO™, a Phase 2 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL) (NCT01882803), and DUO™, a Phase 3 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) (NCT02004522). DYNAMO+RTM, a Phase 3 study of duvelisib in combination with rituximab in patients with previously treated follicular lymphoma (NCT02204982), is expected to start in 2014. Additionally, a Phase 1 study of duvelisib in patients with advanced blood cancers is ongoing (NCT01476657).
Disease: blood cancers, including indolent non-Hodgkin lymphoma (iNHL) and chronic lymphocytic leukemia (CLL)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On November 6, 2014, Infinity Pharmaceuticals announced that new data for duvelisib (IPI-145), an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, will be presented at the American Society of Hematology (ASH) 2014 Annual Meeting, which is being held December 6-9 in San Francisco, CA. Key results to be presented during the meeting include translational data showing the complementary effects of inhibiting both PI3K-delta and PI3K-gamma as well as updated data from the Phase 1 study evaluating the safety and activity of duvelisib in patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL) and relapsed/refractory chronic lymphocytic leukemia (CLL). Updated Phase 1 data on the activity of duvelisib in patients with T-cell lymphoma will also be reported. Presentations of duvelisib at ASH 2014 include the following: - Duvelisib (IPI-145), a PI3K-δ,γ inhibitor, is clinically active in patients with relapsed/refractory chronic lymphocytic leukemia (Abstract Number: 3334) Lead Author: Susan O’Brien, MD, Ashbel Smith Professor and Chief, Section of Acute Lymphocytic Leukemia in the Department of Leukemia, University of Texas, M.D. Anderson Cancer Center - Clinical activity of duvelisib (IPI-145), a phosphoinositide-3-kinase-δ,γ inhibitor, in patients previously treated with ibrutinib (Abstract Number: 3335) Lead Author: Pierluigi Porcu, M.D., Associate Professor of Internal Medicine, Division of Hematology and Comprehensive Cancer Center, Ohio State University - Duvelisib (IPI-145) inhibits malignant B-cell proliferation and disrupts signaling from the tumor microenvironment through mechanisms that are dependent on PI3K-δ and PI3K-γ (Abstract Number: 328) Lead Author: Marisa Peluso, Scientist, Cancer Biology, Infinity Pharmaceuticals, Inc. - A Phase 1 evaluation of duvelisib (IPI-145), a PI3K-δ,γ inhibitor, in patients with relapsed/refractory iNHL (Abstract Number: 802) Lead Author: Ian W. Flinn, M.D., Sarah Cannon Research Institute, Nashville, TN. - Duvelisib (IPI-145), a phosphoinositide-3-kinase-δ,γ inhibitor, shows activity in patients with relapsed/refractory T-cell lymphoma (Abstract Number: 803) Lead Author: Steven Horwitz, M.D., Assistant Attending, Department of Medicine at Memorial Sloan-Kettering Cancer Center, New York, NY
