We are developing IPI-549, an oral, selective inhibitor of phosphoinositide-3-kinase gamma (PI3K-gamma). A Phase 1/1b study is ongoing designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with nivolumab, a PD-1 immune checkpoint inhibitor, in approximately 200 patients with advanced solid tumors. The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin by the end of 2017.
The combination expansion component of the study includes multiple cohorts designed to evaluate IPI-549 in combination with nivolumab in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. Additionally, the combination expansion also includes a cohort of patients with triple negative breast cancer (TNBC) who have not been previously exposed to immune checkpoint blockade therapy.
Additional details about the study can be found on www.clinicaltrials.gov (clinical trials identifier NCT02637531).