Infinity, BMS Expand Clinical Collaboration

Infinity Pharmaceuticals has expanded its clinical collaboration with Bristol-Myers Squibb evaluating IPI-549 in combination with Opdivo to include patients with triple negative breast cancer (TNBC) who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy. IPI-549 is an oral, selective phosphoinositide-3-kinase gamma (PI3K-gamma) inhibitor which targets immune-suppressive tumor macrophages. Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. IPI-549 is currently being evaluated in a Phase 1/1b clinical study in patients with advanced solid tumors and is believed to be the only selective PI3K-gamma inhibitor in clinical development.

Preclinical data have demonstrated that M2, or pro-tumor, macrophages are associated with resistance to checkpoint inhibitor monotherapy, and treatment with IPI-549 in combination with checkpoint inhibitors can overcome this resistance.The addition of a cohort of patients with TNBC provides an important opportunity to explore the potential of the combination of IPI-549 and Opdivo to improve efficacy for patients with a type of cancer where there is limited benefit from monotherapy treatment with checkpoint inhibitors. 

The ongoing Phase 1/1b study is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.