Human breast cancer cells. Credit: Jason Carroll at the CRI
An immunotherapy treatment for triple negative breast cancer has been provisionally rejected for NHS use in England.
The draft guidance from the National Institute for Health and Care Excellence(NICE) does not recommend atezolizumab (Tecentriq) to treat some people with advanced breast cancer that’s spread.
The drug, used in combination with chemotherapy, would have been the first immunotherapy available to this group of patients. NICE estimates that around 600 people could benefit from the treatment, which boosts the immune’s systems ability to recognise and kill cancer cells.
Rose Gray, policy manager at Cancer Research UK, said that people affected by triple negative breast cancer will be “disappointed” by the decision, as they have few other treatment options.
“Clinical trials suggest this combination of drugs could give patients with this aggressive form of breast cancer a few extra months with their friends and family.”
The NICE committee will make a final decision on the immunotherapy treatment in November.
Giving patients more time
Atezolizumab is used with the chemotherapy drug, nab-paclitaxel, to treat patients whose cancer has spread and where surgery to remove the tumour isn’t possible. It would only be an option for patients who haven’t been treated with chemotherapy once their cancer has spread to other parts of the body, and whose tumours tested positive for a molecule called PD-L1.
Atezolizumab stops this molecule from interacting with immune cells, boosting their chances of killing tumour cells.
Clinical trial results reveal the combo can extend the time taken for the disease to worsen by around 2.5 months. People taking the atezolizumab-chemo combo lived without their disease getting worse for 7.5 months on average, compared with 5 months for those treated with chemotherapy and a dummy drug.
The immunotherapy combo is also thought to extend survival compared to chemotherapy alone, although final survival data isn’t expected until 2020.
And although no new adverse effects were reported, side effects from the immunotherapy combination led to 16 in 100 patients stopping treatment, compared with 8 in 100 patients taking chemotherapy and the dummy drug.
Atezolizumab is the first treatment to significantly improve outcomes for this group, whose only option at the minute is chemotherapy. But NICE said it "could not recommend atezolizumab plus nab-paclitaxel as a cost-effective use of NHS resources". The recommendation will not affect patients who are currently receiving the treatment.
NICE decisions are usually adopted in Wales and Northern Ireland as well as England, so the decision is likely to affect patients in all 3 nations. Scotland has a separate process for reviewing drugs.
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said he knew the announcement would be "disappointing” for people with breast cancer.
"Atezolizumab provides for a new way of treating people with significant unmet need, where targeted therapies have not been available to date,” said Boysen. “We are committed to working with the company to try to resolve the issues identified by the committee.”
Right now, NICE recommendations don’t consider the unmet need for new treatments in a particular disease, beyond how much the treatment improves survival and/or quality of life. NICE are reviewing their drug assessment process to decide whether factors like unmet need could be taken into account more directly.
Gray urged NICE, NHS England and the treatment’s manufacturer to work together and agree a deal that will allow the medicine to be approved when it is reviewed next month.