#USA #San Antonio #ORSERDU #Menarini Group #Advanced Cancer

Overview of Menarini Group's Contribution to Breast Cancer Treatment

The Menarini Group has recently announced new findings that will be presented at the 2024 San Antonio Breast Cancer Symposium, further highlighting the significance of their drug, ORSERDU® (elacestrant), for patients diagnosed with advanced and metastatic breast cancer (mBC) classified as ER+ and HER2-. These results herald a promising advancement in treatment options for cancer patients whose tumors feature the ESR1 mutation, a condition found in nearly half of advanced breast cancer cases.

Key Findings from the Symposium

From December 10 to 13, 2024, in San Antonio, Texas, Menarini Group will discuss real-world evidence showcasing ORSERDU®'s efficacy in combating ER+/HER2- mBC. This comes after the FDA's approval of ORSERDU® in January 2023, marking it as the first oral estrogen receptor degrader (SERD) authorized for treating tumors with the ESR1 mutation.

Among the noteworthy findings is the updated analysis of progression-free survival (PFS) metrics for adults undergoing treatment with ORSERDU®. The data suggests a median PFS of 6.8 months across the broader patient demographic, which extends to 8 months for those who have undergone one or two prior lines of endocrine therapy. Virginia Kaklamani, an expert oncologist associated with UT Health San Antonio, emphasized the necessity of continual assessment of tumors for ESR1 mutations so that oncologists can tailor therapy effectively, based on individual patient progression.

Combination Treatments Explored at SABCS 2024

In addition to presenting data on ORSERDU® alone, Menarini Group and its subsidiary, Stemline Therapeutics, Inc., will also share findings regarding the combined use of elacestrant and abemaciclib. Initial results from phase 1b/2 studies have reflected an encouraging profile for this combination therapy, showing that, in patients with ESR1 mutations, the median PFS was reported at 8.7 months. For those without this mutation, the PFS was recorded at 7.2 months, indicating significant efficacy for both groups.

Noteworthy Safety and Efficacy Outcomes

Regarding safety, the combination of elacestrant and abemaciclib exhibited manageable side effects, aligning with historical data concerning both medications. Common adverse events—such as diarrhea, nausea, and fatigue—occurred in over 20% of patients but were not linked with any new severe toxicity indicators. This insight is crucial for oncologists as they strive to optimize patient care and outcomes through careful drug selection.

Elcin Barker Ergun, the Group CEO of Menarini Group, expressed excitement regarding the positive PFS results derived from real-world scenarios and reinforced the company's commitment to further exploring ORSERDU®'s potential as both monotherapy and in combination treatments.

Future Directions and Ongoing Trials

In addition to the crucial data being shared at SABCS 2024, the Menarini Group will discuss findings from the ongoing EMERALD phase 3 trial and multiple investigations exploring the efficacy of elacestrant in advanced breast cancer scenarios. This continued research plays a pivotal role in expanding treatment accessibility and effectiveness for breast cancer patients worldwide.

In summary, the forthcoming symposium in San Antonio epitomizes Menarini Group's dedication to advancing breast cancer treatment via innovative research and drug development. As ORSERDU® continues to showcase its potential, the oncology community remains optimistic about the future possibilities momentarily reflecting patient-focused outcomes in breast cancer care.