Breast cancer patients 'denied precious time with loved ones' as new drug Korserdu rejected on NHS

Breast cancer patients are being “denied precious time” with loved ones after a new drug was rejected for use on the NHS.

Trial data suggests elacestrant may increase how long people with one of the most common forms of breast cancer, which has become resistant to hormone therapies, have before their tumour starts growing again.

However the National Institute for Health and Care Excellence (NICE) says this comes from indirect comparisons with current drugs and has told drugmaker Menarini Stemline it needs more clinical trial data on how long it works for.

Its draft guidance for England does not recommend the drug, also known by its brand name Korserdu, for treating around 1,000 women with a form of hormone therapy resistant cancer with a ESR1 mutation.

Claire Rowney, chief executive at Breast Cancer Now, said: “An ESR1 mutation is a genetic change that often occurs after long-term use of hormone therapy, which is commonly used to treat this type of secondary breast cancer. This mutation is also associated with the disease progressing faster and worse survival rates, yet no targeted treatments are available on the NHS for people with it.

“For people with this type of secondary breast cancer, elacestrant could bring precious additional time with loved ones and doing what matters most to them before the disease progresses, compared to treatments currently available. It’s deeply concerning that patients currently stand to be denied this chance to benefit from extra time.”

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.

Elacestrant is a type of hormone therapy called an oestrogen receptor degrader which 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. But NICE said there is still “considerable uncertainty” around the estimates for how long the drug could be effective for.

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.”

NICE’s draft guidance is open for public consultation until October 22. During 2023-24 three quarters (76%) of topics that were initially not recommended by NICE at consultation turned positive before final guidance was published.

Ms Rowney added: “We understand that NICE has concerns about uncertainties in the data on the clinical effectiveness of elacestrant, and we urge NICE and Menarini Stemline to work closely together to explore all solutions to resolve these issues and see the provisional decision reversed. Unless this happens, patients could be denied the precious chance of being offered this targeted treatment option that gives them more time before their cancer progresses.”