Infinity Inks Deals to Expand Research Into Duvelisib

Julian Adams, PhD

Infinity Pharmaceuticals has entered into two separate agreements with Roche and AbbVie to develop and commercialize duvelisib (IPI-145), an oral inhibitor of PI3K-delta and PI3K-gamma, for the treatment of patients with hematologic malignancies.

The collaboration with Roche includes a master clinical supply agreement as well as a material transfer agreement to study duvelisib in combination with obinutuzumab (Gazyva) for the treatment of hematologic malignancies. The master clinical supply agreement states that Roche will provide obinutuzumab for use in clinical trials while the material transfer agreement states that Infinity will supply Roche with duvelisib for use in preclinical and translational research.

“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,” Julian Adams, PhD, president of research and development at Infinity, said in a statement. “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.”

According to a press release, Infinity will initiate 3 studies in 2014 evaluating duvelisib: a phase Ib/II study of duvelisib in combination with obinutuzumab or rituximab for treatment-naïve patients with indolent non-Hodgkin lymphoma (iNHL) as well as a phase Ib study of duvelisib in combination with obinutuzumab for patients with chronic lymphocytic leukemia (CLL) who have progressed on a BTK inhibitor. Infinity will also launch the phase III DYNAMO+R study, looking at duvelisib in combination with rituximab for patients with follicular lymphoma.

In addition to these trials, the DYNAMO and DUO trials, both part of the DUETTS program, are still ongoing. DYNAMO is a phase II trial looking at duvelisib for patients with refractory iNHL (NCT01882803), while the phase III DUO trial is comparing duvelisib and ofatumumab for the treatment of patients with relapsed or refractory CLL or small lymphocytic lymphoma (NCT02004522). Duvelisib is also being evaluated in an ongoing phase I trial of patients with advanced hematologic malignancies (NCT01476657).

“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,” Vito Palombella, PhD, chief scientific officer at Infinity, said in a statement. “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.”

In a separate agreement, Infinity and AbbVie will jointly develop and commercialize duvelisib. Infinity will receive $275 million up-front and up to $530 million in potential milestones, which includes a maximum of $405 million from the first commercial sale. The companies will equally share profits in the US. Outside the US, AbbVie will commercialize duvelisib while Infinity will receive royalties on net sales.

“We believe that duvelisib is a very promising investigational treatment based on clinical data showing activity in a broad range of blood cancers,” Michael Severino, MD, AbbVie executive vice president and chief scientific officer, said in a statement. “The addition of duvelisib will complement AbbVie’s emerging oncology pipeline and expand our research into combination therapies to generate improved outcomes for cancer patients.”