Date: 2014-09-03
Type of information: Clinical research agreement
Compound: Gazyva® (obinutuzumab) and duvelisib (IPI-145)
Company: Roche (Switzerland) Infinity Pharmaceuticals (USA - MA)
Therapeutic area: Cancer - Oncology
Type agreement:
Action mechanism:
Disease: blood cancers
Details: * On September 3, 2014, Infinity Pharmaceuticals announced that it has entered into a master clinical supply agreement with Roche under which Roche will supply Gazyva® (obinutuzumab) to Infinity for use in planned clinical studies to evaluate the combination of Gazyva and duvelisib (IPI-145), Infinity\'s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with hematologic malignancies, or blood cancers. The companies have also entered into a material transfer agreement under which Infinity is supplying Roche with duvelisib for use in Roche\'s preclinical and translational research to evaluate the combination of duvelisib and Gazyva®. In 2014, Infinity plans to initiate a Phase 1b/2 clinical study of duvelisib in combination with Gazyva® or rituximab in patients with previously untreated indolent non-Hodgkin lymphoma (iNHL). Infinity also expects to initiate in 2014 a Phase 1b clinical study of duvelisib in combination with Gazyva® in patients with chronic lymphocytic leukemia (CLL) whose disease has progressed following treatment with a Bruton\'s tyrosine kinase (BTK) inhibitor. These studies are in addition to Infinity\'s plans to initiate this year DYNAMO+RTM, a global Phase 3 study evaluating duvelisib in combination with rituximab in patients with follicular lymphoma. Other global, registration-focused trials evaluating the safety and efficacy of duvelisib are ongoing, including DYNAMOTM, a Phase 2 study in patients with iNHL, and DUOTM, a Phase 3 study in patients with CLL.
Roche also plans to study duvelisib as part of its preclinical and translational efforts in hematology. These research efforts will be part of Roche\'s ongoing efforts to further understand the therapeutic potential of Gazyva in combination with both approved medicines and experimental therapies.
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