MEN1611 is a phosphatidylinositol 3-kinase (PI3K) inhibitor discovered by Chugai and acquired by the Menarini Group at the end of 2016.
PI3K is considered a critical component in the signaling pathway that regulates proliferation, differentiation and survival of tumor cells.
MEN1611 has been successfully tested in a phase I study for solid tumors in Europe, displaying high selectivity for class I enzyme that may lead to a differentiated profile compared to other PI3K inhibitors.
The development plan is focused on clearly defined target populations with high unmet medical need.
In 2018 the B-PRECISE-01 clinical trial started. This is a multicenter phase Ib study currently ongoing to evaluate the safety and efficacy of MEN1611 plus trastuzumab with or without fulvestrant in patients with PIK3CA-mutated, HER2-positive, advanced or metastatic (a/m) breast cancer who have failed anti-HER2 based therapy.
Moreover, a phase Ib/II study is currently ongoing to investigate MEN1611 in patients with metastatic colorectal cancer (C-PRECISE-01).
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