Roche’s Tecentriq ®▼ (atezolizumab) not approved for triple negative breast cancer

Image of a woman undergoing medical examination highlighting Tecentriq by Roche not approved on NHS for triple negative breast cancer

Draft guidance published by NICE does not recommend atezolizumab, Roche’s Tecentriq®▼, for treating people with a type of breast cancer that has spread to other parts of the body.

Atezolizumab, given with chemotherapy agent nab-paclitaxel, is the first immunotherapy that specifically targets triple negative breast cancer where tumours have PD-L1 expression of 1% or more. It is given to people who have not had prior chemotherapy for metastatic disease and where surgery to remove the tumour is not possible.

The evidence suggests that atezolizumab plus nab-paclitaxel extends the time before the disease worsens by around 2.5 months compared to placebo plus nab-paclitaxel (7.5 months versus 5.0 months respectively). It also suggests that atezolizumab plus nab-paclitaxel increases overall survival by around 9.5 months (25.0 months versus 15.5 months respectively).

However, there was no trial data directly comparing atezolizumab plus nab-paclitaxel with other treatments currently used at this stage – weekly paclitaxel and docetaxel – and the committee felt that the company’s analysis indirectly comparing these treatments was unreliable and lacked validity.

When using nab-paclitaxel as a proxy for current treatment in the NHS, NICE’s independent committee could not recommend atezolizumab plus nab-paclitaxel as a cost-effective use of NHS resources, even after applying end-of-life criteria.

Advanced triple negative breast cancer has a huge negative impact on the quality of life of patients. It can be more aggressive than other types of breast cancer (despite accounting for only 15–20% of breast cancer cases, it accounts for 25% of deaths) and it often affects women of a younger age who may have young children and caring responsibilities. The committee heard from the patient expert that the emotional burden of the disease on the family is high.

Given by injection every two weeks, atezolizumab works by blocking the activity of a protein known as PD-L1 which is produced in larger amounts on cancerous cells than normal cells. By blocking PD-L1 it helps the person’s own immune cells to attack the cancer.

The cost of a course of treatment with atezolizumab is £39,981 based on treatment for 7.5 months at its full list price but the company offered the NHS a confidential discount.

An estimated 2000 people in England have triple negative breast cancer, of whom around 600 people would be eligible for treatment with atezolizumab and nab-paclitaxel.

Atezolizumab with nab-paclitaxel does not meet NICE’s Cancer Drugs Fund criteria because it does not have a plausible potential to be cost-effective and there is no clear evidence that further trial data would resolve the uncertainties associated with this appraisal.

In March, Roche funded early access to atezolizumab (Tecentriq®▼) and nab-paclitaxel for breast cancer following a positive scientific opinion by the UK’s Medicines and Healthcare products Regulatory Agency, under the Early Access to Medicines Scheme.

Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE, said: “I know that today’s announcement will be disappointing for people with breast cancer, and for their families and carers. Atezolizumab provides for a new way of treating people with significant unmet need, where targeted therapies have not been available to date.

“The committee heard that the availability of a new treatment that increases progression-free survival compared with chemotherapy alone will give hope to patients because it is important to them to be able to maintain a good quality life for as long as possible.

“We are committed to working with the company to try to resolve the issues identified by the committee. In the meantime, I would encourage anyone with an interest in this topic to give us their feedback on this draft guidance.”

Consultation on the draft guidance is open until 24 October 2019. The appraisal committee will reconsider the draft guidance in light of the comments received at its meeting on 12 November 2019.