Olubukola Ayodele: NICE approves Elacestrant for advanced breast cancer

Olubukola Ayodele, Consultant Medical Oncologist at the University Hospitals of Leicester NHS Trust, posted the following on LinkedIn:

“It is encouraging to share that NICE has made a crucial decision by granting the green light in the final draft for the use of Elacestrant in the second line and beyond for patients with HR+/HER2- advanced breast cancer harboring an ESR1 mutation after at least 12 months of endocrine treatment. This advancement is a positive step for many in the community affected by this diagnosis.

HR+/HER2- breast cancer represents the most common subtype, accounting for 70% of cases. It is important to recognize that approximately 10–15% of individuals present with advanced or metastatic disease at their initial diagnosis. Moreover, around 35% of patients treated with curative intent in the early stages may progress to metastatic disease within ten years. These statistics highlight the critical need for effective treatments like Elacestrant.

The presence of ESR1 mutations can complicate the prognosis, as these mutations are linked to poorer survival outcomes and often develop as a result of prolonged exposure to endocrine therapies. The occurrence rate of such mutations varies, ranging from 20–40% in advanced breast cancer. This underscores the necessity of providing patients with improved treatment options.

While this news is promising, it is important to understand that several factors will influence the timeline for when oncologists can begin prescribing this drug:

1.The current status is a final draft, and we look forward to the official publication to solidify this advancement.

2.Inclusion of the drug in the CDF list is essential for ensuring reimbursement, which will facilitate access for patients.

3.Trusts will need to engage pharmacists to develop a comprehensive protocol for prescribing on platforms like Chemocare.

4.A significant challenge lies in streamlining the testing needed for ESR1 mutations. Although tissue testing can be requested through the Genomic Laboratory Hub (GLH), it requires a fresh biopsy. This may not be feasible for all patients and can introduce an additional layer of stress during an already challenging time. Furthermore, tissue biopsies may not always capture the full spectrum of mutations due to the heterogeneity seen in breast cancer.

Given these challenges, liquid biopsy with ctDNA is the best platform for ESR1-mutation detection because it can analyze multiple hotspots and clones simultaneously, offering a minimally invasive approach that is cost-effective and requires less tumor material with a higher sensitivity rate.

Overall, while this development is a cause for optimism, it is essential to address the pathways for testing and implementation comprehensively. By doing so, we can ensure that patients have access to this important treatment when it becomes available for prescription, and that no one is left behind in this journey towards better cancer care.”

Dr. Olubukola Ayodele is a Consultant Medical Oncologist at the University Hospitals of Leicester NHS Trust, specializing in breast and genitourinary malignancies, including germ cell tumors. She is also an honorary Senior Lecturer at the University of Leicester and heads the Breast Cancer Clinical Trials Unit at the Leicester Cancer Research Centre.

Dr. Ayodele’s work includes numerous publications, clinical trials, and collaborative research projects on molecular drivers and biomarkers in breast cancer. She is a member of ASCO, ESMO, ACP and UKBCG.