Date: 2015-10-06
Type of information: update on patient enrollment
phase: 2
Announcement: update on patient enrollment
Company: Infinity Pharmaceuticals (USA - MA)
Product: duvelisib
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: indolent non-Hodgkin lymphoma
Therapeutic area: Cancer - Oncology
Country: Belarus, Belgium, Bulgaria, Canada, Czech Republic, France, Georgia, Hungary, Italy, Spain, Ukraine, UK, USA
Trial
details: This phase 2 clinical trial evaluates the safety and efficacy of IPI-145 as a monotherapy in subjects with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma) that is refractory to rituximab and to either chemotherapy or RIT. (NCT01882803)
Latest
news: * On October 6, 2015, Infinity Pharmaceuticals announced that the 120th patient had been enrolled in DYNAMO, a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib (25 mg BID) in patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint is overall response rate. Topline data is anticipated in the third quarter of 2016, and Infinity anticipates the submission of global regulatory filings by the end of 2016. This enrollment milestone triggered an obligation for AbbVie Inc. to pay Infinity a $130 million payment. AbbVie is Infinity\'s global development and commercial partner for duvelisib in oncology.
