NICE recommendation for KORSERDU®▼ (elacestrant) marks ‘step-change’ in the treatment of ESR1-mutated metastatic breast cancer

NICE recommendation for KORSERDU®▼ (elacestrant) marks ‘step-change’ in the treatment of ESR1-mutated metastatic breast cancer 

• Elacestrant is the first tailored treatment for certain people with oestrogen receptor (ER)-positive HER2-negative locally advanced and metastatic breast cancer that is ESR1 mutated.

• Around 1,000 patients could be eligible for treatment with elacestrant in England and Wales each year.

LONDON, UK, 19^th December 2024 – Menarini Stemline UK today welcomed final draft guidance from the National Institute for Health and Care Excellence (NICE) recommending use of the first tailored treatment for locally advanced and metastatic breast cancer that has acquired mutations in the ESR1 gene, estimated to benefit around 1,000 patients in England and Wales each year. Specifically, elacestrant will be available on the NHS to treat post-menopausal women, and men, with oestrogen receptor (ER)-positive HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation that has progressed after at least 1 line of endocrine therapy including a CDK4/6 inhibitor, provided the cancer progressed after at least 12 months of such treatment.[i] This recommendation makes elacestrant the first treatment available on the NHS for breast cancer that is specifically indicated to overcome treatment resistance caused by ESR1 mutations that have developed in response to prior hormone therapy.

“One of the challenges in treating locally advanced and metastatic breast cancer is how the disease can mutate and develop resistance to treatment,” said Professor Mark Beresford, Consultant Clinical Oncologist at the Royal United Hospital Bath and chair of UKBCG. “Until now, the ability to overcome the treatment resistance caused by ESR1 mutations has been limited and, as a result, patients can face the need to move on to chemotherapy or see their cancer progress rapidly. The availability of elacestrant is a step-change in the treatment of this cancer, offering the potential to slow the progression of advanced breast cancer with a mutated ESR1 gene by months, giving people precious time with their family members and loved ones.”

Approximately 80% of cases of breast cancer are hormone receptor-positive (HR+), meaning it grows in response to hormones like oestrogen.[ii] These cancers are commonly treated with hormone-based therapy, also called endocrine therapy. However, a proportion of these patients (up to 50%[iii]^,[iv]) will acquire mutations in the ESR1 gene that can render conventional hormone therapy less effective than in patients without the mutation. The mutated ESR1 gene drives growth of the cancer even in the absence of oestrogen.[v] In the recommended population of patients who test positive for ESR1 mutations, elacestrant works by degrading the oestrogen receptors on tumour cells, which may help limit the cancer’s ability to grow and divide.

“Living with metastatic breast cancer can have a devastating impact on individuals and their loved ones,” said Jo Taylor, Founder of METUPUK. “The availability of any new treatment option is crucial, particularly when tailored options with the potential to slow cancer progression are so limited. This decision marks a significant moment in the treatment of locally advanced and metastatic breast cancer, and we hope it will enable those eligible on the NHS to access the testing and the treatment they desperately need.”

“This outcome is a reflection of the strong collaboration and support from the breast cancer community and the willingness of NICE to work closely with Menarini Stemline to reach a decision that enables eligible people to have access to elacestrant,” said Rick Coope, General Manager at Menarini Stemline UK. “We are incredibly proud to reach this milestone for people living with locally advanced and metastatic breast cancer, a disease where timely access to new treatment options is of the utmost importance. Now, our focus is to work closely with stakeholders across the healthcare system to ensure that potentially eligible patients can access testing for ESR1 mutations without delay.”

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▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.  Adverse events should also be reported to Menarini Stemline.

To report SUSPECTED ADVERSE REACTIONS: EUPV@menarinistemline.com

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Or by telephone for any of these queries: 0800-0478675

[i] NICE. Elacestrant for treating oestrogen receptor-positive, HER2-negative advanced breast cancer with an ESR1 mutation after at least 1 endocrine treatment [ID6225]. Available via this link. Last accessed: December 2024.

[ii] Cancer Research UK. Tests on your breast cancer cells. Available via this link. Last accessed: December 2024.

[iii] Jhaveri, K. et al. Annals of Oncology. 2023; 34 (suppl_2): S334-S390. Available via this link.

[iv] Lin, N.U. et al. Annals of Oncology. 2023; n.d.;34(S2):S338. Available via this link.

[v] Brett JO et al. Breast Cancer Res. 2021;23(1):85; 2. Available via this link.