The article from the National Institute for Health and Care Excellence (NICE) titled “NICE ready to work with company to address uncertainty in evidence for elacestrant for advanced breast cancer” highlights crucial details regarding the evaluation and potential use of elacestrant breast cancer therapy. Elacestrant is specifically under review for its effectiveness in treating oestrogen receptor-positive, human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer with an activating ESR1 mutation, which complicates hormone therapies.

Key Points

Condition and Treatment

– Elacestrant is being considered for treating oestrogen receptor-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation. This particular mutation can cause hormone therapies to stop working, leading to cancer progression.

Mechanism of Action

– As an oestrogen receptor degrader, elacestrant binds to and degrades oestrogen receptors, blocking oestrogen’s ability to bind to breast cancer cells and promote their growth.

Draft Guidance

– NICE has issued draft guidance that does not currently recommend elacestrant for this type of advanced breast cancer due to uncertainty in the evidence. This draft is open for public consultation until 22 October 2024.

Evidence and Uncertainty

– The evidence indicates that elacestrant may improve the time before the breast cancer worsens compared to standard care. However, there is considerable uncertainty surrounding these estimates. NICE has requested further analysis from the company to clarify and address this uncertainty.

Patient Eligibility

– It is estimated that about 1,000 individuals could be eligible for treatment with elacestrant breast cancer therapy.

Use of Severity Modifier

– NICE is examining whether to apply a severity modifier, which would give additional weight to the benefits of medicines based on the severity of the disease. This evaluation will continue at the committee’s next meeting on 12 November 2024.

Company and Stakeholders

– The company involved, Menarini Stemline, is collaborating with NICE to address the uncertainties in the evidence for elacestrant. Various patient, carer, and professional groups are also participating in the consultation process.

Context of Previous Recommendations

– Historically, around three-quarters (76%) of topics that were not initially recommended by NICE at the draft stage ended up receiving a positive recommendation before the final guidance was published. This trend suggests that there remains a potential for elacestrant to be recommended if the uncertainties can be successfully resolved.