Menarini Ricerche Announces Dose Escalation Results of the Clinical Trial of MEN1611 in Breast Cancer

Findings from B-PRECISE-01 Study Presented at the ESMO Virtual Congress 2020

POMEZIA, Italy, Sept. 17, 2020 /PRNewswire/ -- Menarini Ricerche, the R&D division of the Menarini Group, today announced the results of the dose escalation part of its B-PRECISE-01 clinical trial (NCT03767335) which is evaluating MEN1611, a potent and selective phosphatidylinositol 3-kinase (PI3K) inhibitor in development for the treatment of breast cancer.

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The poster entitled "Results of the phase 1b dose escalation study of MEN1611, a PI3K Inhibitor, combined with trastuzumab (T) ± fulvestrant (F) for HER2+/PIK3CA mutant (mut) advanced or metastatic (a/m) breast cancer (BC)" (ID number: 347P) will be presented at the 2020 Virtual Annual Congress of the European Society for Medical Oncology (ESMO), which will take place on September 19-21.

B-PRECISE-01 is an open-label, multicenter, phase Ib, dose escalation and expansion study conducted in patients with HER2-positive, PIK3CA mutated, advanced or metastatic breast cancer, which has progressed after at least two lines of anti-HER2-based therapy. The primary objectives of the study were to determine the safety and the recommended Phase 2 dose (RP2D) of MEN1611 in combination with trastuzumab +/- fulvestrant. Secondary objectives include assessing preliminary clinical activity, pharmacokinetics and pharmacodynamics.

The combination of MEN1611 + trastuzumab +/- fulvestrant has shown an acceptable tolerability profile with no dose-limiting toxicities during the escalation phase, and most treatment emergent adverse events were reversible and manageable with supportive care. The RP2D was established at 48 mg BID. Promising antitumor activity in heavily pretreated patients, together with prolonged disease control, provided the rationale for continuing with the cohort expansion phase of the B-PRECISE-01 study, to test the RP2D in patients with HER2-positive, PIK3CA mutated, advanced or metastatic breast cancer.

About Menarini Menarini Ricerche is the Menarini Group's division dedicated to R&D, with a strong commitment to oncology research and development, as well as an active engagement in the infectious disease area, being involved in the fight against the antimicrobial resistance threat, a rising global concern.

As part of its commitment to oncology, Menarini's pipeline includes five investigational new drugs for the treatment of a variety of hematological and/or solid tumors: two biologics (the monoclonal antibody anti-CD157 MEN1112/OBT357, and toxin-conjugated anti-CD205 antibody MEN1309/OBT076), and three small molecules (the dual PIM and FLT3 kinase inhibitor SEL24/MEN1703, the PI3K inhibitor MEN1611, and the inhibitor of class I, II, and IV histone deacetylase, Pracinostat).

The acquisition of Stemline Therapeutics, a New York-based biopharmaceutical company, strengthened Menarini's oncology portfolio with the addition of both commercial and clinical-stage assets, including ELZONRIS® a novel targeted therapy for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). Menarini has also entered into a license agreement with Radius Health for the development and commercialization of Elacestrant, an oral SERD in late stage Phase 3 development as hormonal treatment for breast cancer. Through the work of Menarini Silicon Biosystems, Menarini is also developing advanced technologies and products to study rare cells with single-cell precision.

The Menarini Group is a leading international pharmaceutical and diagnostics company, with turnover of EUR3.793 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, gastroenterology, pneumology, infectious diseases, diabetology, inflammation, and analgesia. With 16 production sites and 10 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information please visit www.menarini.com [http://www.menarini.com/]

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CONTACT: Priscilla De Rosa, via Tito Speri 10, 00071 Pomezia (Rome - Italy), e-mail: pderosa@menarini, ricerche.it, Tel. 0039 0691184619, Mob. 0039 3408412952

Web site: http://www.menarini.com//

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