Presentation of Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA 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 Presented at the 2023 San Antonio Breast Cancer Symposium

Introduction:
The 2023 San Antonio Breast Cancer Symposium witnessed the presentation of initial safety and efficacy data from the Phase 1b/2 ELEVATE and ELECTRA combination studies of ORSERDU® (Elacestrant) in patients with ER+, HER2- metastatic breast cancer (mBC). These studies aimed to evaluate the potential of ORSERDU® in combination with other therapies to improve outcomes for this patient population. The results presented at the symposium shed light on the promising efficacy and safety profile of ORSERDU®, offering hope for a new treatment option for ER+, HER2- mBC patients.

Background:
ER+ (estrogen receptor-positive), HER2- (human epidermal growth factor receptor 2-negative) metastatic breast cancer is a subtype of breast cancer that accounts for a significant proportion of cases. Despite advancements in treatment options, ER+ mBC remains challenging to manage due to the development of resistance to endocrine therapies. Therefore, there is an urgent need for novel therapeutic approaches to improve patient outcomes.

ORSERDU® (Elacestrant):
ORSERDU® (Elacestrant) is an investigational, orally administered selective estrogen receptor degrader (SERD). It works by blocking the estrogen receptor signaling pathway, inhibiting tumor growth, and potentially overcoming resistance to endocrine therapies. The Phase 1b/2 ELEVATE and ELECTRA combination studies aimed to evaluate the safety and efficacy of ORSERDU® in combination with other agents in ER+, HER2- mBC patients.

ELEVATE Study:
The ELEVATE study evaluated the combination of ORSERDU® with CDK4/6 inhibitors, a class of drugs that inhibit proteins involved in cell cycle progression. The study enrolled patients who had previously received CDK4/6 inhibitor therapy and experienced disease progression. Preliminary results from the ELEVATE study demonstrated encouraging efficacy, with a significant proportion of patients achieving disease control and durable responses. The combination therapy also exhibited a manageable safety profile, with adverse events consistent with those observed with individual agents.

ELECTRA Study:
The ELECTRA study investigated the combination of ORSERDU® with PI3K inhibitors, which target the PI3K/AKT/mTOR pathway involved in cancer cell growth and survival. This study enrolled patients who had previously received PI3K inhibitor therapy and experienced disease progression. Initial data from the ELECTRA study revealed promising efficacy outcomes, including objective response rates and disease control rates. The combination therapy was generally well-tolerated, with manageable side effects.

Safety Profile:
The safety profile of ORSERDU® in both the ELEVATE and ELECTRA studies was consistent with previous findings from monotherapy trials. The most common adverse events reported were mild to moderate in severity and included fatigue, nausea, and diarrhea. Notably, the combination therapies did not exhibit any unexpected or severe toxicities, suggesting a favorable safety profile for ORSERDU® in combination with CDK4/6 inhibitors or PI3K inhibitors.

Conclusion:
The presentation of initial safety and efficacy data from the Phase 1b/2 ELEVATE and ELECTRA combination studies of ORSERDU® at the 2023 San Antonio Breast Cancer Symposium provides encouraging results for ER+, HER2- metastatic breast cancer patients. The combination therapies demonstrated promising efficacy outcomes while maintaining a manageable safety profile. These findings highlight the potential of ORSERDU® as a novel treatment option for ER+, HER2- mBC patients who have developed resistance to endocrine therapies. Further investigation and larger-scale clinical trials are warranted to validate these preliminary results and establish ORSERDU® as a valuable addition to the treatment armamentarium for this patient population.

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