Bristol-Myers Squibb Company and Infinity Pharmaceuticals have announced a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo in combination with Infinity’s IPI-549 in patients with advanced solid tumors.
The dose-escalation portion exploring IPI-549 as a monotherapy in Infinity’s Phase 1 study is continuing, and the first dose-escalation cohort studying IPI-549 in combination with Opdivo, a PD-1 immune checkpoint inhibitor, is expected to begin this fall. IPI-549 is an oral immuno-oncology development candidate that is designed to selectively inhibit phosphoinositide-3-kinase (PI3K)-gamma and is the only investigational PI3K-gamma inhibitor in clinical development.
Preclinical data suggest that IPI-549 may enhance the effects of checkpoint inhibitors and may also reverse tumor resistance to checkpoint inhibitors by targeting immune cells and altering the immune-suppressive microenvironment, promoting an anti-tumor immune response. Opdivo is designed to overcome immune suppression. The combination phase of this ongoing Phase 1 study in patients with advanced solid tumors will explore the potential of combining these two agents to drive improved and sustained efficacy and tolerability above the current standard of care by targeting the immune-suppressive cells in the tumor microenvironment, companies said in their press release.
“Targeting the tumor microenvironment is an important part of our Immuno-Oncology strategy as we continue to advance research for cancers with limited treatment options,” stated Fouad Namouni, M.D., Head of Oncology Development, Bristol-Myers Squibb. “Our agreement with Infinity builds on our continued focus to bring forward potential novel combination treatment options for patients with cancer.”
“We are excited to explore the potential clinical benefits of combining IPI-549 with Opdivo in the next phase of our ongoing Phase 1 study, which is expected to begin this fall,” stated Julian Adams, president of research and development at Infinity. “Our preclinical research demonstrates that IPI-549 may enhance the effects of and reverse tumor resistance to checkpoint inhibitors, providing a strong rationale for evaluating this combination in patients with advanced forms of solid tumors.”