Date: 2014-01-28
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Infinity Pharmaceuticals (USA - MA)
Product: duvelisib and ofatumumab
Action
mechanism: monoclonal antibody/phosphoinositide 3-kinase (PI3K) inhibitor. Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. The drug has been developed under a co-development and commercialization agreement between Genmab and GSK. In April 2014, Novartis has agreed to acquire GSK oncology productsincluding ofatumumab. IPI-549 (duvelisib) is an oral immuno-oncology development candidate that is designed to selectively inhibit phosphoinositide-3-kinase (PI3K)-gamma. In preclinical studies, IPI-549 inhibited 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 represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.
Disease: chronic lymphocytic leukemia, small lymphocytic lymphoma
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Belgium, France, Germany, Hungary, Italy, New Zealand, Spain, UK, USA
Trial
details: The study is a phase 3 extension study of duvelisib and ofatumumab in patients with chronic lymphocytic leukemia/ small lymphocytic lymphoma previously enrolled in study IPI-145-07. (NCT02049515)
Latest
news: * On January 28, 2014, a Phase 3 trial sponsored by Infinity Pharmaceuticals was published on the NIH website ClinicalTrials.gov for duvelisib and ofatumumab and is currently recruiting participants.
