Infinity Pharmaceuticals, Inc. has 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.
“We believe that duvelisib has the potential to be the best-in-class PI3K inhibitor and that Gazyva has the potential to be the best-in-class anti-CD20 therapy, so we are pleased to have entered into these agreements with Roche. Our ability to evaluate duvelisib in combination with Gazyva in multiple clinical studies is part of Infinity’s strategy to combine duvelisib with both current standards of care and novel, targeted therapies,” stated Julian Adams, president of research and development at Infinity. “We look forward to beginning clinical studies of duvelisib plus Gazyva, including the first study in indolent non-Hodgkin lymphoma evaluating Gazyva in combination with a PI3K inhibitor.”
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+R™, 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 DYNAMO™, a Phase 2 study in patients with iNHL, and DUO™, 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.
“Duvelisib targets both PI3K-delta and PI3K-gamma, two proteins that play critical roles in the growth and survival of tumor cells,” stated Vito Palombella, Ph.D., chief scientific officer at Infinity. “We are pleased that Roche’s preclinical and translational science teams will be studying duvelisib in combination with Gazyva to understand how they may work together. We hope Roche’s research will contribute to our understanding of how duvelisib works in combination with other therapies, including Gazyva, as we seek to improve outcomes for patients.”