Thousands of women with advanced breast cancer England and Wales is denied a drug that reduces the risk of spreading the disease by more than a third.
Enhertu has been rolled out to patients with HER2-low breast cancer in Scotland and Northern Ireland, but the National Institute for Health and Care Excellence (Nice) has rejected it for patients in England. Women in Wales are also being denied the drug.
Compelling evidence suggests that the treatment, also known as trastuzumab deruxtecan, can increase the amount of time patients live and give them more time before their disease progresses.
Now “really exciting” new data, published at the world’s largest cancer conference, suggests that Enhertu is even more powerful than previously thought.
Results of the Destiny-Breast06 study, presented at the American Society of Clinical Oncology (Asco) annual meeting in Chicago, show that the drug can halt the growth of tumors for more than a year, significantly longer than standard chemotherapy.
Overall, Enhertu reduced the risk of cancer growth or spread in patients with HER2-low breast cancer by 38% compared to those who received chemotherapy. The data will put pressure on regulators to approve the drug for women in England Wales.
Charities have warned that women’s lives will be “cut short” with further delays as they called for Enhertu to be made available to women in England and Wales as quickly as possible.
Dr Simon Vincent, director of research, support and influence at Bors Cancer Now, said: “This promising study suggests that even more people could potentially benefit from Enhertu, offering patients with HER2-low or HER2-ultra-low secondary breast cancer who have already had hormone-based therapy more time to live without that their cancer spreads further.
“It builds on existing evidence that this treatment can increase overall survival by more than six months for people with HER2-low secondary breast cancer who have already had chemotherapy.
“Yet, despite this increasing clinical data emerging around the clear benefit that Enhertu can bring to patients, thousands of people with HER2-low secondary breast cancer are being denied access to Enhertu on the NHS in England, and this is completely unacceptable.
“These people are desperately counting on Nice, NHS England, Daiichi Sankyo and AstraZeneca to find a solution in their current discussions and to make this treatment available to them as a matter of urgency.”
Sophie Blake, 51, was diagnosed with HER2-low breast cancer in December 2020 before being told in May 2022 that it had spread elsewhere, including to her lungs and liver.
The former television presenter’s cancer is under control, but Enhertu is likely to be a last resort treatment when needed.
In response to the new trial results presented in Chicago, she said: “This is yet another proof of the precious extra time this treatment can give us.
“When we are so limited in what options are available, it is particularly devastating. We know women in Scotland whose lives it has changed, it’s not just that it gives you an extension, it’s also the quality of life.”
The mother-of-one, from Brighton, added: “For us these miracle drugs are everything – I want to see my daughter go to university, get married and have children, Enhertu can make that difference to women. We are moms, we are sisters, we are daughters, we are workers, we contribute to society and yet we are told that our lives are not considered cost effective.
“The most frustrating thing is that we know it’s there – they just won’t give it to us.”
All invasive breast cancers are tested for HER2 (human epidermal growth factor receptor 2) levels. Some breast cancer cells have a higher than normal level of HER2 on their surface, which stimulates them to grow.
Breast Cancer Now said about 50% of all breast cancers show low levels of HER2. It estimates that 1,000 women with HER2-low advanced breast cancer in England and Wales would benefit from Enhertu but are denied access to the drug.
The trial presented at Ascpo involved 866 women with advanced HER2-low breast cancer. Those who received Enhertu saw disease progression halted for an average of 13.2 months, compared to 8.1 months for those who received chemotherapy.
Women who received Enhertu were more likely to experience side effects compared to those on chemotherapy, which experts said showed that the drug may not be the right choice for every patient.
“It won’t be for every patient, but it’s certainly exciting news for us that will have an impact on our practice,” said Dr. Erica Mayer, director of breast cancer clinical research at the Dana-Farber Cancer Institute in Boston, Massachusetts. .
The treatment was blocked for NHS use in England in March. Nice said the cost the NHS was being asked to pay for Enhertu was “too high” in relation to its benefits.
A quarter of a million people have signed a petition calling for an “urgent solution” to get the treatment to women living with secondary breast cancer as soon as possible.
