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Menarini Group News

2019 - 09 - 23

ESMO Annual Meeting 2019: Menarini Ricerche presents the preclinical characterization of MEN1611, a novel PI3K inhibitor in development for the treatm


Pomezia (Italy) September 23rd, 2019 – Promising results from the preclinical study conducted by Menarini Ricerche on MEN1611, a potent and selective orally available phosphatidylinositol 3-kinase (PI3K) inhibitor currently in development for the treatment of breast cancer. The poster entitled “Characterization of the mechanism of action and efficacy of MEN1611, a novel PI3K inhibitor, in breast cancer preclinical models” will be presented at the ESMO Annual Meeting 2019, which will take place in Barcelona on September 27th, during the poster display session scheduled on September 30th (time 12-13).


The PI3K/AKT signaling pathway is often dysregulated in patients with cancer: about 25% of HER2-positive breast cancers carry PIK3CA gene mutations, known to confer resistance to anti-HER2 therapy (i.e. trastuzumab). This study, conducted in several HER2-positive PIK3CA-mutated breast cancer cell lines and patient-derived xenograft models, shows that MEN1611 is able to down-modulate the PI3K/AKT pathway both in vitro and in vivo, and acts synergistically when combined with trastuzumab; moreover, the in vivo efficacy in trastuzumab-resistant models is demonstrated by a long lasting antitumor activity.

These promising preclinical data, provide a strong rationale for MEN 1611 progression in clinical development in breast cancer patients.  In this regard, the B-Precise-01 clinical trial (NCT03767335), a multicentre phase Ib study, is currently ongoing in Europe with the aim to evaluate the preliminary clinical activity of MEN1611 in combination with trastuzumab +/- fulvestrant, in patients affected by advanced or metastatic HER2-positive breast cancer, and to select the recommended phase 2 dose

This year Menarini Ricerche will be present at ESMO congress also with a dedicated area at the MenariniSilicon Biosystems booth, where it will be possible to get more detailed information about the entire Menarini oncology pipeline and the ongoing clinical trials. Indeed, MEN1611 is part of an innovative pipeline of investigational new drugs focused on precision medicine approaches, that represents the strong and growing commitment of Menarini to oncology and to patients affected by difficult to treat cancers.