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▎Editor of WuXi AppTec Content Team On October 20, 2021, Menarini Group and Radius Health announced that selective estrogen receptor degradant (SERD) elacestrant has obtained positive results in a phase 3 clinical trial
.
The trial aims to evaluate the efficacy of elacestrant as a single-agent treatment compared with standard treatment (SoC) in the treatment of patients with ER+/HER2- advanced or metastatic breast cancer
.
The trial reached two primary endpoints, namely total subject progression-free survival (PFS), and PFS of patients with estrogen receptor 1 (ESR1) mutant tumors, and both showed a statistically significant improvement
.
The safety profile of the drug in the trial is similar to previous studies
.
Breast cancer is one of the most common forms of cancer in the United States
.
According to estimates by the National Cancer Institute (NCI), approximately 250,000 women were diagnosed with breast cancer in 2017, and more than 40,000 of them died
.
Estrogen receptor positive, HER2 negative (ER+/HER2-) is the most common form of breast cancer
.
Elacestrant is an oral selective estrogen receptor degrading agent that has the potential to be used as a monotherapy or a member of combination therapy to treat breast cancer
.
The study included 466 patients who had previously received first-line or second-line endocrine therapy, including cyclin-dependent kinase (CDK) 4/6 inhibitor therapy
.
220 (47%) of the tumors carried ESR1 mutations
.
ESR1 mutation is an important driving factor for endocrine therapy resistance in patients with ER+/HER2 metastatic breast cancer
.
Image source: Professor Aditya Bardia, the principal investigator of the 123RF trial, said: “These patient populations urgently need additional treatment options
.
The
statistically significant results of the trial indicate that in patients who have previously received endocrine therapy and CDK4/6 inhibitor therapy Compared with standard treatment, patients in the elacestrant group showed a clinically significant improvement in PFS
.
This result provides hopeful hope for patients with this devastating disease
.
Positive data from patients with ESR1 mutations are also important because of the ESR1 mutation Will produce additional resistance to standard endocrine therapies
.
” Menarini Group CEO Elcin Barker Ergun commented: “We are extremely excited because elacestrant is the first monotherapy in a key clinical trial that is comparable to SoC as a monotherapy.
Compared with oral SERD, which has shown positive top-line results in the treatment of patients with ER+/HER2-advanced or metastatic breast cancer
.
This result paves the way for us to cooperate with regulatory agencies to bring new therapies to patients as soon as possible
.
"Reference: [1] Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer.
Retrieved October 20, 2021, from https://ir.
radiuspharm.
com/news-releases/news -release-details/menarini-group-and-radius-health-announce-positive-phase-3 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is only for information exchange purposes, and the views in the article are not It represents WuXi AppTec's position, and does not mean that WuXi AppTec supports or opposes the views
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital
.