NICE ready to work with company to address uncertainty in evidence for elacestrant for advanced breast cancer
Today (1 October 2024) NICE is consulting on draft guidance that does not recommend elacestrant for treating a type of advanced breast cancer.
The draft guidance, which is open for public consultation until 22 October, does not recommend elacestrant for treating oestrogen receptor-positive, human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer with an activating ESR1 mutation.
The company proposed that elacestrant (also called KORSERDU and made by Menarini Stemline) is used when the cancer has got worse after at least 12 months of treatment with hormone therapy and a type of treatment designed to interrupt the growth of cancer cells called a CDK 4/6 inhibitor.
Elacestrant is the first targeted treatment for this type of advanced breast cancer that has an ESR1 mutation.
Evidence suggest that elacestrant may increase how long people have before their breast cancer gets worse compared with standard care. But there is considerable uncertainty about the estimates.
We have asked the company for further clarification and analyses ahead of the committee’s next meeting on 12 November. This includes analyses to enable the committee to determine whether a severity modifier allowing extra weight to be given to the benefits of medicines based on the severity of the disease should be applied.
The committee heard how living with incurable secondary breast cancer can be distressing and stressful for the person and their family and carers, affecting all aspects of their lives. The main area of uncertainty the committee had to contend with was the estimates for how long elacestrant stopped the disease from getting worse compared with current clinical practice. It also meant the committee could not confirm at this stage whether a severity modifier could be applied. We stand ready to work with the company to try and address the issues identified by the committee in this draft guidance.
During 2023-24 three quarters (76%) of topics that were initially not recommended by us at draft guidance stage turned positive before final guidance was published.
Oestrogen receptor positive, HER2- breast cancer is the most common type of breast cancer. Up to half of the advanced or metastatic breast cancers treated with hormone therapy develop mutations in the oestrogen receptor gene, ESR1, on disease progression. The ESR1 gene makes oestrogen receptors, which receive signals from oestrogen that tell the cancer to grow. This can cause some hormone therapies to stop working and the cancer to progress.
Elacestrant is a type of hormone therapy called an oestrogen receptor degrader. It works by stopping oestrogen-dependent cancer cells from growing by binding to and degrading oestrogen receptors, blocking oestrogen’s ability to bind to breast cancer cells
It is estimated around 1,000 people would have been eligible for elacestrant if we had recommended it.