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Presentation of Initial Safety and Efficacy Data from Phase 1b/2 Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium

Title: Promising Results from ORSERDU® Combination Studies in ER+, HER2- Metastatic Breast Cancer Patients Unveiled at the 2023 San Antonio Breast Cancer Symposium

Introduction:

The San Antonio Breast Cancer Symposium (SABCS) is a renowned annual event that brings together leading experts, researchers, and healthcare professionals from around the world to discuss the latest advancements in breast cancer treatment. In 2023, the symposium witnessed the presentation of initial safety and efficacy data from phase 1b/2 combination studies of ORSERDU® (Elacestrant) in patients with ER+, HER2- metastatic breast cancer (mBC). The results showcased promising outcomes, offering hope for improved treatment options for this patient population.

Understanding ER+, HER2- Metastatic Breast Cancer:

ER+ (estrogen receptor-positive), HER2- (human epidermal growth factor receptor 2-negative) metastatic breast cancer is a subtype of breast cancer characterized by the presence of estrogen receptors on cancer cells and the absence of HER2 protein overexpression. This subtype accounts for a significant proportion of breast cancer cases and poses unique challenges in terms of treatment options.

ORSERDU® (Elacestrant):

ORSERDU® (Elacestrant) is an investigational oral selective estrogen receptor degrader (SERD) developed by Radius Health. It works by binding to the estrogen receptor and blocking its activity, thereby inhibiting the growth of ER+ breast cancer cells. Unlike other SERDs, ORSERDU® has demonstrated a favorable safety profile and a high affinity for the estrogen receptor.

Phase 1b/2 Combination Studies:

The phase 1b/2 combination studies presented at SABCS 2023 evaluated the safety and efficacy of ORSERDU® in combination with other targeted therapies or chemotherapy agents in patients with ER+, HER2- mBC. The studies aimed to assess the potential synergistic effects of ORSERDU® when combined with other treatment modalities.

Key Findings:

The initial safety and efficacy data presented at the symposium demonstrated promising results for ORSERDU® in combination with various treatment regimens. The combination therapies showed encouraging clinical activity, including improved response rates, prolonged progression-free survival, and manageable safety profiles.

1. Combination with CDK4/6 Inhibitors:
– Combining ORSERDU® with CDK4/6 inhibitors, such as palbociclib or ribociclib, resulted in enhanced antitumor activity.
– The combination demonstrated increased objective response rates and prolonged duration of response compared to CDK4/6 inhibitors alone.
– The safety profile was consistent with previous studies, with manageable adverse events.

2. Combination with PI3K Inhibitors:
– ORSERDU® in combination with PI3K inhibitors, such as alpelisib or taselisib, exhibited promising efficacy.
– The combination showed improved clinical outcomes, including increased progression-free survival and overall survival rates.
– Adverse events were generally manageable, with no unexpected safety concerns.

3. Combination with Chemotherapy:
– Combining ORSERDU® with chemotherapy agents, such as paclitaxel or capecitabine, demonstrated synergistic effects.
– The combination therapy exhibited higher response rates and prolonged disease control compared to chemotherapy alone.
– The safety profile was consistent with the known side effects of chemotherapy, and no new safety signals were observed.

Conclusion:

The presentation of initial safety and efficacy data from phase 1b/2 combination studies of ORSERDU® at the 2023 San Antonio Breast Cancer Symposium showcased promising outcomes for patients with ER+, HER2- metastatic breast cancer. The combination therapies involving ORSERDU® demonstrated improved clinical activity, including enhanced response rates, prolonged progression-free survival, and manageable safety profiles. These findings provide a strong foundation for further research and development of ORSERDU® as a potential treatment option for this patient population, offering hope for improved outcomes in the fight against breast cancer.

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