Today (1 October 2024) NICE is consulting on draft guidance that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The draft guidance, which is open for public consultation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.
There are currently no targeted treatments available on the NHS
for this type of advanced breast cancer that has an ESR1
mutation. Indirect comparisons 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.
NICE has asked the company for further clarification and analyses
ahead of its 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 a medicine
should be applied.
Helen Knight, director of health technology evaluation at
NICE, said: “The committee heard how living with
incurable secondary breast cancer is 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 was unable to 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issues identified by the committee in this draft guidance.”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 NICE at consultation 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 be eligible for
treatment with elacestrant if NICE were to recommend it.
The draft guidance
on elacestrant for treating oestrogen
receptor-positive, HER2-negative advanced breast cancer with an
ESR1 mutation after at least 1 endocrine treatment is
available on the NICE
website.
