Thousands of women with advanced breast cancer in England and Wales are being denied a drug that cuts the risk of the disease spreading by more than a third.
Enhertu has been approved for HER2-low breast cancer patients 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 denied drugs.
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 the 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 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 stop the growth of tumors for more than a year, significantly longer than standard chemotherapy.
Overall, Enhertu reduced the risk of cancer growing or spreading in patients with low HER2 breast cancer by 38% compared to those who received chemotherapy. The data will pile pressure on regulators to approve the drug for women in England and Wales.
The charities warned that women’s lives would be “cut short” by further delays as 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 impact at Breast Cancer Now, said: “This promising study suggests that even more people could potentially benefit from Enhertu, offering patients with secondary HER2-low or HER2 breast cancer -ultralow who have already had hormones -based therapy longer to live without their cancer spreading further.
“This is based 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.
“However, despite this growing clinical data emerging about the clear benefit 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 totally unacceptable.
“These people are desperately relying on Nice, NHS England, Daiichi Sankyo and AstraZeneca to find a solution in their current talks and 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 it had spread elsewhere, including to her lungs and liver, in May 2022.
The former TV presenter’s cancer is under control, but Enhertu would probably be the last line of treatment when needed.
Responding to the new trial results presented in Chicago, she said: “This is even more evidence of the precious extra time this treatment can give us.
“When we’re so limited with the options available, it’s especially devastating. We know women in Scotland whose lives have changed, it’s not just that it gives you an extension, it’s the quality of life too.”
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 can make that difference for women. We are mothers, we are sisters, we are daughters, we are workers, 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 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 that 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 included 866 women with HER2-low advanced breast cancer. Those who received Enhertu saw disease progression halted for an average of 13.2 months, compared with 8.1 months for those on chemotherapy.
Women who took Enhertu were more likely to experience side effects compared to those on chemotherapy, which experts said may not be the right choice for every patient.
“This won’t be for every patient, but this is definitely 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 women living with secondary breast cancer treatment as soon as possible.