Thousands of women with advanced breast cancer in England and Wales are being denied a drug that reduces the risk of the disease spreading 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 extend patients’ lives and give them more time before their disease develops.
Now “really exciting” new data, published at the world’s largest cancer conference, suggests that Enhertu is even more powerful than previously thought.
Results from the Destiny-Breast06 study, presented at the annual meeting of the American Society of Clinical Oncology (Asco) in Chicago, show that the drug can slow tumor growth by 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 and Wales.
Charities warned that women’s lives “will be cut short” if further delays occur. They called for Enhertu to be made available to women in England and Wales as soon as possible.
Dr. Simon Vincent, director of research, support and advocacy at Breast Cancer Now, said: “This promising study suggests that even more people could potentially benefit from Enhertu, by offering patients with HER2-low or HER2-ultra-low secondary breast cancer who have already had hormone therapy. -based therapy more time to live without their cancer spreading further.
“This 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.
“Despite increasing clinical data emerging around the clear benefit that Enhertu could offer patients, thousands of people with HER2-low secondary breast cancer are being denied access to Enhertu through 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 make this treatment available to them urgently.”
Sophie Blake, 51, was diagnosed with HER2-low breast cancer in December 2020 before being told in May 2022 that the disease had spread to other places, including her lungs and liver.
The former television host’s cancer is under control, but Enhertu would likely be a last line of treatment if needed.
Commenting on the new research results presented in Chicago, she said: “This is further proof of the valuable extra time this treatment could save us.
“When we are so limited in the options available to us, it is particularly devastating. We know women in Scotland whose lives it has changed. It’s not that it just gives you extension, it’s also about the quality of life.”
The mother-of-one from Brighton added: “For us these wonder drugs are everything – I want to see my daughter go to university, get married and have children, Enhertu could make that difference for women. We are mothers, we are sisters, we are daughters, we are employees, we contribute to society, but we are told that our lives are not considered cost-effective.
“The most frustrating thing is that we know it’s there – they just don’t want to give it to us.”
All invasive breast cancers are tested for HER2 (human epidermal growth factor receptor 2) levels. Some breast cancer cells have higher than normal levels of HER2 on their surface, which stimulates them to grow.
Breast Cancer It is now said that approximately 50% of all breast cancers show low levels of HER2. It is estimated 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 study presented at Ascpo involved 866 women with advanced HER2-low breast cancer. Those who received Enhertu had disease progression halted for an average of 13.2 months, compared to 8.1 months in those who received chemotherapy.
Women who received Enhertu were more likely to experience side effects than women who received chemotherapy, which experts said showed the drug may not be the right choice for every patient.
“This won’t apply to every patient, but this is absolutely exciting news for us that will impact our practice,” said Dr. Erica Mayer, director of breast cancer clinical research at Dana-Farber Cancer Institute in Boston, Massachusetts.
The treatment was blocked from use by the NHS in England in March. Nice said the costs the NHS had to pay for Enhertu were “too high” compared to its benefits.
A quarter of a million people have signed a petition calling for an ‘urgent solution’ to get treatment as quickly as possible for women with secondary breast cancer.