8 March 2022

Background

The National Institute for Health and Care Excellence (NICE) has today (Tuesday 8th March 2022) announced its provisional decision not to recommend pembrolizumab in combination with chemotherapy,* when it could bring certain patients with secondary triple negative breast cancer* an important, additional treatment option.

Pembrolizumab (also known as Keytruda) and made by Merck Sharp & Dohme (MSD) has a marketing authorisation for use in combination with chemotherapy for the treatment of locally recurrent unresectable or secondary triple negative breast cancer in patients whose tumours express PD-L1 with a Combined Positive Score (CPS) ≥ 10 and who have not received prior chemotherapy for their secondary disease.

Pembrolizumab is a type of immunotherapy called an immune checkpoint inhibitor – it helps the immune system to recognise and attack cancer cells. Pembrolizumab specifically targets and blocks a protein called PD-1 on the surface of some immune cells.

Currently, if eligible patients are PDL1 positive (using the assay associated with atezolizumab) they would receive atezolizumb with nab-paclitaxel.

The clinical evidence is based on the KEYNOTE-355 clinical trial.

Median overall survival was 23 months with the pembrolizumab combination versus 16.1 months with chemotherapy alone. So, an additional 6.9 months on average. Median progression free survival was 9.7 months with the pembrolizumab combination versus 5.6 months with chemotherapy alone. So, an additional 4.1 months on average.

The NICE committee has concluded that the pembrolizumab combination is more effective than paclitaxel or docetaxel however that the relative effectiveness of pembrolizumab versus atezolizumab is uncertain. NICE estimate that around 600 people in England with advanced triple negative breast cancer would have been eligible for treatment with the pembrolizumab combination.

There is now a period of consultation until 29 March 2022 and a further NICE committee meeting will follow before a final decision is made on the routine us of this treatment on the NHS.

Responding to the news, Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“We’re deeply disappointed that NICE is provisionally unable to recommend pembrolizumab in combination with chemotherapy,* when it could bring certain patients with secondary triple negative breast cancer* an important, additional treatment option.

“People living with this particularly aggressive form of breast cancer face a poorer prognosis, and until recently, extremely limited first-line treatment options. Whilst another immunotherapy treatment, atezolizumab, has been available on the NHS since 2020, some patients may be ineligible for this combination,* making the availability of the pembrolizumab combination vital to ensuring every patient has the chance to potentially benefit from it, including from the precious extra time it can offer patients before their disease progresses and additional months to live, compared to chemotherapy.

“NICE recognises the unmet need for this immunotherapy treatment for patients. We now urge Merck Sharp & Dohme and NICE to explore all possible solutions to get today’s provisional decision reversed, including reconsidering the decision not to apply the end-of-life criteria to this treatment.”

ENDS

Notes to Editor

*pembrolizumab (Keytruda) in combination with chemotherapy (paclitaxel or nab-paclitaxel).

*for treating triple negative, locally recurrent unresectable or secondary breast cancer in patients whose tumours express PD-L1 with a combined positive score of 10 or more and who have not had prior chemotherapy for their secondary breast cancer.

*Because each treatment option includes a different measurement of PD-L1 expression and there are some instances in which only 1 measurement would show PD-L1 positivity and when the results of both measures would not overlap.

*people who cannot have the atezolizumab with chemotherapy (nab-paclitaxel) combination.