Abstract
Immune checkpoint blockade (ICB) improves survival in metastatic melanoma (MM), but many pts progress or recur and ultimately die from this disease. PTEN loss, which occurs in up to 30% of MM pts, activates the PI3K-AKT pathway and correlates with decreased tumor infiltrating lymphocytes (TIL) and lower response rate (RR) to ICB. In preclinical models of PTEN-null melanoma selective inhibition of PI3Kβ with G771 combined with ICB increased CD4+/8+ TIL and survival. Thus, we conducted a phase I/II study (NCT01458067) of PI3Kβi + P in pts w/ PTEN loss, including PD-1 refractory MM.
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