Menarini Presents Data at SABCS 2024 Showcasing ORSERDU®’s Potential in ER+/HER2- Metastatic Breast Cancer
The Menarini Group and its subsidiary, Stemline Therapeutics, are set to unveil new and expanded findings on ORSERDU® (elacestrant) at the 2024 San Antonio Breast Cancer Symposium (SABCS). These data emphasize the role of ORSERDU in improving treatment outcomes for patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) advanced or metastatic breast cancer (mBC). The company’s presentations include real-world progression-free survival (rwPFS) results and combination therapy studies involving elacestrant and abemaciclib, further underscoring ORSERDU’s efficacy and safety.
Real-World Data on ORSERDU
ORSERDU, the first oral selective estrogen receptor degrader (SERD) approved to target ESR1 mutations in ER+/HER2- mBC, has demonstrated meaningful clinical outcomes in real-world settings. ESR1 mutations, which develop in up to 50% of ER+/HER2- mBC patients after endocrine therapy (ET), are a key driver of endocrine resistance. Since its FDA approval in January 2023, ORSERDU has been integrated into clinical practice, providing oncologists with a vital tool for managing advanced disease.
Real-world evidence to be presented at SABCS 2024 shows that ORSERDU monotherapy achieved a median rwPFS of 6.8 months in ER+/HER2- mBC patients. Subgroup analyses revealed an extended rwPFS of 8 months in patients with one or two prior lines of ET in the metastatic setting. These results highlight ORSERDU’s effectiveness across diverse patient populations and its alignment with clinical trial outcomes.
Dr. Virginia Kaklamani of UT Health San Antonio and MD Anderson Cancer Center emphasized the importance of testing tumors for ESR1 mutations at disease progression to optimize treatment. “These exciting real-world data affirm the need for ESR1 mutation testing via liquid biopsy to better tailor therapies for patients,” she stated.
Combination Therapy with Elacestrant and Abemaciclib
In addition to monotherapy data, Menarini will present findings from the ELECTRA and ELEVATE phase 1b/2 trials exploring the combination of elacestrant with abemaciclib. These studies investigate strategies to overcome ET resistance and improve patient outcomes.
Updated results from ELECTRA show that the combination yielded a median progression-free survival (mPFS) of 8.6 months across all efficacy-evaluable patients. Subgroup analyses revealed mPFS of 8.7 months in patients with ESR1 mutations and 7.2 months in those without. The pooled safety analysis from ELECTRA and ELEVATE confirmed a manageable safety profile consistent with the known profiles of both agents. Common adverse events included diarrhea, nausea, neutropenia, and fatigue, with no Grade 4 events reported.
Dr. Hope Rugo of the University of California, San Francisco, praised the findings: “These results demonstrate encouraging PFS data and a favorable safety profile, reinforcing the potential of elacestrant as a foundational endocrine therapy for combination regimens.”
Commitment to Research and Expansion
Menarini remains dedicated to advancing the clinical development of elacestrant. The company aims to unlock ORSERDU’s full potential by expanding its applications in combination therapies and exploring its use in new patient populations. CEO Elcin Barker Ergun expressed excitement about the real-world findings, emphasizing Menarini’s focus on providing oncologists with effective tools to improve patient outcomes.
Menarini will also share insights from the pivotal EMERALD trial and several ongoing studies, including ELEGANT, which investigates elacestrant in high-risk, early-stage breast cancer, and ADELA, a phase 3 trial exploring combination therapy with everolimus.
Key Presentations at SABCS 2024
Menarini and Stemline will showcase several abstracts at SABCS, including:
- Elacestrant real-world PFS data (Poster P3-10-08)
- Elacestrant + abemaciclib combination outcomes (Poster PS7-07)
- Phase 3 EMERALD trial ESR1 mutation analysis (Poster P1-01-25)
- ELEVATE trial updates on elacestrant combinations (Poster PS7-06)
About ORSERDU and Menarini
ORSERDU is a novel oral SERD specifically approved for ESR1-mutated ER+/HER2- mBC, addressing a critical need for patients with advanced disease. Menarini Group, headquartered in Italy, focuses on advancing oncology treatments through innovation and global research efforts. Stemline Therapeutics, its U.S. subsidiary, continues to drive the development of cutting-edge cancer therapies.
Menarini’s presence at SABCS 2024 highlights its commitment to advancing breast cancer care and solidifying ORSERDU’s position as a transformative treatment option for mBC.
