The potential of AstraZeneca (AZ) and Daichii Sankyo’s targeted treatment for advanced breast cancer, Enhertu (trastuzumab deruxtecan), has been recognised by the National Institute for Health and Care Excellence (NICE), despite not being recommending as a treatment for adults with HER2-low breast cancer.
The institute has requested further analysis of trastuzumab on how it impacts people’s length of life, the benefits of the treatments as the condition worsens, and the outcomes of standard of care given in the NHS.
Helen Knight, director of medicines evaluation at NICE, said: “Trastuzumab deruxtecan represents a potentially significant development for people with this type of advanced breast cancer who currently have limited chemotherapy options and no targeted treatments available to them.”
However, she added that there were “a number of uncertainties in the company’s economic model”, which meant that “cost-effectiveness estimates were too high for it to be recommended for use in the NHS”.
Resulting in 685,000 deaths worldwide in 2020, breast cancer is one of the leading causes of cancer-related deaths globally.
The tyrosine kinase receptor growth-promoting protein, HER2, expresses on the surface of varying types of tumours, including breast, lung, gastric and colorectal cancers, and is one of many biomarkers in breast cancer tumours.
Currently, Enhertu is approved for use in more than 30 countries, including Europe and China, as a HER2-directed therapy for patients with HER2-low metastatic breast cancer.
The phase 3 Destiny-Breast04 trial results showed that Enhertu significantly reduced the risk of disease progression or death by 50% in patients versus physicians’ choice of chemotherapy in patients with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease.
Dave Fredrickson, executive vice president of AZ’s oncology business unit, explained: “Historically, patients with breast cancer who have tumours with low levels of HER2 expression have been classified as HER2-negative, giving them limited treatment options beyond chemotherapy.”
He added that the approval of Enhertu “highlights the need to evolve the way breast cancer is treated to improve patient outcomes”.
NICE has highlighted several areas in need of clarification by the company before their next meeting and will work with the company to address them.