Thousands of women with advanced breast cancer in England and Wales have been denied a drug that cuts the risk of the disease spreading by more than a third.
Enhertu was introduced to HER2-low breast cancer patients in Scotland and Northern Ireland, but was rejected by the National Institute for Health and Care Excellence (Nica) for patients in England. Women in Wales are also denied drugs.
Compelling evidence suggests that the treatment, also known as trastuzumab deruxtecan, can prolong patients’ lives and give them more time before their disease progresses.
Now «really exciting» new data, published at the world’s biggest cancer conference, suggests that Enhertu is even more powerful than previously thought.
The results of 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 tumor growth 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 receiving chemotherapy. The data will increase pressure on regulators to approve the drug for women in England and Wales.
The charities warned that women’s lives would «be cut short» with further delays as they called for Enhert 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 HER2-low or HER2-ultralow secondary breast cancer who have already had hormone therapy more time to live without further spread of cancer.
“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 received chemotherapy.
“Yet, despite this growing body of clinical data emerging around the clear benefit Enhertu could 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 deeply 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 low HER2 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 host’s cancer is under control, but Enhert would likely be the last line of treatment when needed.
Responding to the new trial results presented in Chicago, she said: “This is further evidence of the valuable 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 for whom it has changed their lives, not just the extension, but the quality of life.»
The mother-of-one, from Brighton, added: “These miracle drugs are everything to us – I want to see my daughter go to university, get married and have children, Enhertu could do that 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 worthwhile.
«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 encourages them to grow.
Breast Cancer Now says that around 50% of all breast cancers show low levels of HER2. An estimated 1,000 women with low HER2 advanced breast cancer in England and Wales would have benefited from Enhertu but have been denied access to the drug.
The trial presented at Ascpo included 866 women with HER2-low advanced breast cancer. Those receiving Enherta saw disease progression halted for an average of 13.2 months, compared to 8.1 months for those on chemotherapy.
Women receiving Enherta were more likely to experience side effects compared to those on chemotherapy, which experts say shows the drug may not be the right choice for every patient.
«This is not going to 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 had to pay for Enherta was «too high» compared to its benefits.
A quarter of a million people have signed a petition calling for an «urgent solution» to get women with secondary breast cancer treated as soon as possible.