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Menarini to Launch Trial Evaluating PI3K Inhibitor MEN1611 in Metastatic Colorectal Cancer

NEW YORK – Italian pharmaceutical company Menarini has announced plans to launch a new Phase Ib/II clinical trial evaluating MEN1611, the company's investigational PI3K inhibitor, in combination with the EGFR inhibitor cetuximab (Lilly's Erbitux) for patients with metastatic colorectal cancer.

The aims of the trial, which Menarini expects to launch in the second half of 2020 with the name "C-PRECISE-01," are to identify the maximum tolerated dose and antitumor activity of MEN1611 in patients with metastatic, PIK3CA-mutated, RAS and RAF wildtype colorectal cancer who have experienced disease progression after treatment with the FOLFOXIRI chemotherapy regimen as well as previous anti-EGFR containing regimens.

The company previously launched a Phase Ib trial, which is ongoing, for MEN1611 plus trastuzumab (Genentech's Herceptin) with or without fulvestrant (AstraZeneca's Faslodex) for the treatment of patients with metastatic, HER2-positive breast cancer. According to Menarini, preclinical and clinical evidence support MEN1611 combined with other agents for the treatment of solid tumors. Because PIK3CA mutations in metastatic colorectal cancer have been shown to negatively predict response to EGFR-targeting agents, the company says that PI3K is an "attractive therapeutic target" for the oral investigational agent.

"The initiation of the C-PRECISE-01 trial will give us the possibility to investigate the potential of MEN1611 in a disease with high medical need, where PIK3CA represents a suitable therapeutic target," Andrea Pellacani, general manager of Menarini's research and development arm, said in a statement. "This confirms our commitment to advance precision oncology and develop effective healthcare solutions that can make the difference for cancer patients.”