On May 19, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that new data will be presented for duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place from June 9 – 12, 2016, in Copenhagen (Press release, Infinity Pharmaceuticals, MAY 19, 2016, View Source;p=RssLanding&cat=news&id=2169736 [SID:1234512585]). At the meeting, preliminary data from CONTEMPO, a Phase 1b/2 study evaluating duvelisib in combination with rituximab or obinutuzmab in treatment-naïve follicular lymphoma patients, will be presented in a poster session. Duvelisib is the only dual inhibitor of PI3K-delta,gamma in Phase 3 clinical development and is in registration-focused studies in patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL) and relapsed/refractory chronic lymphocytic leukemia (CLL). Infinity and AbbVie are jointly developing duvelisib in oncology.
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Additionally, posters reviewing ongoing clinical studies of duvelisib and IPI-549, Infinity’s investigational immuno-oncology development candidate that selectively inhibits PI3K-gamma, will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago from June 3 – 7, 2016.
Presentations and publications are listed below. All abstracts are available on the conference websites.
EHA 2016
Friday, June 10, 2016, 11:15 a.m. ET – 12:45 p.m. ET (5:15 p.m. – 6:45 p.m. CEST) (poster presentation)
Title: Preliminary Safety, Pharmacokinetics, and Pharmacodynamics of Duvelisib Plus Rituximab or Obinutuzumab in Patients with Previously Untreated CD20+ Follicular Lymphoma
Abstract Number: P319
Lead Author: Carla Casulo, M.D., James P. Wilmont Cancer Center Strong Memorial Hospital, University of Rochester
Location: Hall H
ASCO 2016
Sunday, June 5, 2016, 9:00 a.m. – 12:30 p.m. ET (8:00 a.m. – 11:30 a.m. CT) (poster session)
Title: IPI-549-01-A phase 1/1b First-in-Human Study of IPI-549, a PI3K-Gamma Inhibitor, as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Abstract Number: TPS3111
Lead Author: Anthony W. Tolcher, M.D, Director of Clinical Research, South Texas Accelerated Research Therapeutics (START)
Location: Hall A
Monday, June 6, 2016, 9:00 a.m. – 12:30 p.m. ET (8:00 a.m. – 11:30 a.m. CT) (poster session)
Title: FRESCO: A Phase 2, Randomized Study of Duvelisib Plus Rituximab vs R-CHOP in Patients with Relapsed/Refractory Follicular Lymphoma Who Have Progressed within 24 Months of Receiving an Alkylator-Based Chemotherapy Regimen.
Abstract Number: TPS7578
Lead Author: Nathan Fowler, M.D., Associate Professor at the Department of Lymphoma/Myeloma, University of Texas, MD Anderson Cancer Center
Location: Hall A
ASCO Publication Only
Title: Preliminary Safety, Pharmacokinetics, and Pharmacodynamics of Duvelisib Plus Rituximab or Obinutuzumab in Patients with Previously Untreated CD20+ Follicular Lymphoma
Abstract Number: #e19052
Lead Author: Carla Casulo, M.D., James P. Wilmont Cancer Center Strong Memorial Hospital, University of Rochester
About Duvelisib
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment. 1-3AbbVie and Infinity Pharmaceuticals, Inc. are jointly researching and developing duvelisib in various cancer types.
Duvelisib is being evaluated in several studies, including a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma4, a Phase 3 study in combination with other agents in patients with previously treated follicular lymphoma5 and a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia6. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.
About IPI-549
IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune-suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.
These are investigational drugs being studied for indications that have not been approved by Regulatory Agencies. Safety and efficacy have not been established in unapproved indications.