A wonder drug denied to thousands of women in England with incurable breast cancer could keep their disease stable for almost twice as long as chemotherapy, a study suggests.
Findings presented at the world’s largest cancer conference have added fuel to the fire for campaigners who are demanding that health chiefs and manufacturers strike a deal.
Sophie Blake, 51, is among patients desperate to access the drug, Enhertu. She was diagnosed with breast cancer in December 2020 and received the devastating news that it had become terminal in May 2022.
She said: “This is yet more evidence of the precious extra time this treatment could give us.
“These wonder drugs are everything. I want to watch my daughter go to university, get married and have children. Enhertu could make that difference to women.
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“We’re mums, we’re sisters, we’re daughters, we’re workers, we contribute to society yet we’re being old our lives aren’t considered cost effective.”
The drug is used to treat secondary breast cancer that has spread around the body. Delivered via an intravenous infusion, it targets a protein called HER2 which helps tumour cells grow quickly.
Engertu is available on the NHS for women with high levels, known as HER2-positive.
But it has been rejected for those who are considered HER2-low despite growing evidence it can also buy them precious extra months with loved ones.
A new trial involving almost 900 women classed as HER2-low or ultralow found 57 percent of those given Enhertu responded to the treatment. This compared with just 32 percent who had chemotherapy.
Patients on the drug saw their disease remain stable for an average of 13.2 months, compared with 8.1 months with chemo.
The results were presented at the American Society for Clinical Oncology’s annual conference in Chicago.
An estimated 1,000 women in England with HER2-low breast cancer could benefit from the drug.
Sophie’s cancer is under control for now. But she believes Enhertu could eventually give her “another life-extending line of treatment”.
The former TV presenter, from Brighton, added: ‘‘When we’re so limited with what options are available, it’s particularly devastating.
“We know women in Scotland whose lives it’s changed, it’s not that it just gives you an extension, it’s also the quality of life.
‘The most frustrating thing is that we know it’s there – they just won’t give it to us.”
Enhertu is available on the NHS in Scotland for HER2-low women. But it was rejected for this group in England after the National Institute for Health and Care Excellence (NICE) ruled the benefits did not justify the cost.
NICE delayed publication of final guidance to allow more time for confidential price negotiations.
Manufacturers AstraZeneca and Daiichi Sankyo accused NICE of using “flawed methodology” in its assessments.
But in a letter to the Health Select Committee, NICE claimed Daiichi Sankyo had withdrawn a previous offer and upped the price. It added: “A fair price being offered…could resolve this issue almost immediately.”
A Breast Cancer Now petition demanding a deal has received more than 260,000 signatures.
Dr Simon Vincent, the charity’s director of research, support and influencing, said the situation was “utterly unacceptable”.
He added: “This promising study suggests even more people could potentially benefit from Enhertu, offering patients with HER2-low or HER2-ultralow secondary breast cancer who have already had hormone-based therapy more time to live without their cancer spreading further.
“This builds on existing evidence that this treatment can increase overall survival by over six months for people with HER2-low secondary breast cancer who have already had chemotherapy.
“These people are desperately counting on NICE, NHS England, Daiichi Sankyo and AstraZeneca to find a solution in their current talks and to urgently make this treatment available for them.”
A NICE spokesperson said: “We are extremely disappointed not to be able to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer.
“As we made clear during our oral evidence session to the recent Health Select Committee, a price making it a cost-effective use of NHS resources being offered by Daiichi Sankyo and AstraZeneca could resolve this issue almost immediately.
“That is the fastest and only guaranteed way of ensuring women get access to this treatment without further delay.”