Elacestrant is approved by FDA for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Orserdu for breast cancer

Share This Post

In February 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for women or men over 50 who have advanced or metastatic breast cancer and are ER-positive, HER2-negative, and have ESR1 mutations. The disease has progressed after at least one line of endocrine therapy.

The Guardant360 CDx assay was also given FDA approval as a companion diagnostic tool for elacestrant treatment of patients with breast cancer.

EMERALD (NCT03778931), a randomised, open-label, active-controlled, multicenter trial that included 478 postmenopausal women and men with advanced or metastatic breast cancer in whom 228 patients had ESR1 mutations, investigated the effectiveness of the treatment. Patients had to have seen disease progression after receiving one or more lines of endocrine therapy in the past, including at least one line that contained a CDK4/6 inhibitor. Patients who were eligible could have had up to one prior line of chemotherapy for advanced or metastatic disease. Elacestrant 345 mg orally once daily was given to patients who were randomly assigned (1:1) to receive it or investigator’s choice of endocrine therapy, which included fulvestrant (n=166) or an aromatase inhibitor (n=73). ESR1 mutation status (found vs. not found), previous fulvestrant treatment (yes vs. no), and visceral metastasis were used to divide the patients into groups for randomization (yes vs. no). The Guardant360 CDx assay was used to identify ESR1 missense mutations in the ligand binding domain and was limited to blood circulating tumour deoxyribonucleic acid (ctDNA).

The main efficacy outcome measure was progression-free survival (PFS), which underwent evaluation by a blinded imaging review committee. In the population with ITT and in the subgroup of patients with ESR1 mutations, there was a statistically significant difference in PFS.

The median PFS was 3.8 months (95% CI: 2.2, 7.3) for the 228 (48%) patients with ESR1 mutations treated with elacestrant and 1.9 months (95% CI: 1.9, 2.1) for those treated with fulvestrant or an aromatase inhibitor (hazard ratio [HR] of 0.55 [95% CI: 0.39, 0.77], 2-sided p-value=0.0005).

The 250 (52%) patients without ESR1 mutations in the exploratory analysis of PFS had an HR of 0.86 (95% CI: 0.63, 1.19) indicating that the results seen in the ESR1 mutant population were predominantly responsible for the improvement in the ITT cohort.

Musculoskeletal pain, nausea, elevated cholesterol, elevated AST, elevated triglycerides, fatigue, decreased haemoglobin, vomiting, elevated ALT, elevated sodium, elevated creatinine, decreased appetite, diarrhoea, headache, constipation, abdominal pain, hot flush, and dyspepsia were the most frequent adverse events (10%), including laboratory abnormalities.

It is advised to take 345 mg of elacestrant once daily with food until the disease progresses or the toxicity becomes intolerable.

View full prescribing information for Orserdu.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Claudin18.2-targeted CAR-T cell therapy brings complete remission in advanced pancreatic cancer patient A case report
CAR T-Cell therapy

Claudin18.2-targeted CAR-T cell therapy brings complete remission in advanced pancreatic cancer patient : A case report

Claudin18.2-targeted CAR-T cell therapy has shown remarkable potential in treating advanced pancreatic cancer, as highlighted in a recent case report. This innovative approach led to complete remission in a patient with advanced disease, underscoring the promise of targeted immunotherapy. By leveraging the specific expression of Claudin18.2 on cancer cells, this therapy offers a precision-based treatment, heralding a new era in pancreatic cancer management with significant clinical implications.

What is the treatment after BCMA CAR T failed in RR multiple myeloma cases
CAR T-Cell therapy

What is the treatment after BCMA CAR T failed in R/R multiple myeloma cases?

For people with relapsed or refractory multiple myeloma, BCMA CAR T-cell therapy might not work. Other treatments, such as bispecific antibodies, other CAR T-cell therapies that target different antigens, and combination regimens with immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies, can still be used. OriCAR-017 is another immunotherapy that is under trial and is expected to be launched soon. Clinical trials offer experimental treatments, providing access to novel therapies. Tailored approaches based on patient-specific factors and emerging research are crucial for improving outcomes in this challenging scenario.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy