National Institute for Health and Clinical Excellence (NICE)
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New injectable immunotherapy treatment for rare form of triple negative breast cancer recommended by NICE

An estimated 100 people per year with triple negative breast cancer that has spread to other parts of the body may soon benefit from pembrolizumab in combination with chemotherapy (paclitaxel or nab-paclitaxel) following the final draft recommendation from NICE.

Pembrolizumab is used with chemotherapy in adults with triple negative breast cancer whose tumours express PD-L1 with a combined positive score (CPS - the number of PD-L1 positive cells in relation to tumour cells) greater than or equal to 10 who have not had chemotherapy for metastatic disease and where surgery to remove the tumour is not possible.

Clinical trial evidence shows that, compared with paclitaxel, pembrolizumab combination increases how long people have before their cancer gets worse and how long they live.

NICE already recommends atezolizumab in combination with chemotherapy for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer. The population covered by NICE’s appraisal of pembrolizumab in combination with chemotherapy covers some, but not all, of those who are eligible to have atezolizumab in combination with chemotherapy. This is because for atezolizumab, PD-L1 expression is measured using a slightly different method called immune cell staining (IC). Atezolizumab combination is recommended by NICE for people with IC equal to or greater than 1%.  This means that some people who can’t have atezolizumab combination could be eligible for pembrolizumab combination.

Following consultation on the previous draft guidance the company proposed that the pembrolizumab combination should be restricted to people whose tumours express PD-L1 with a CPS greater than or equal to 10 and IC <1%. This means that atezolizumab combination is no longer a direct comparator, thereby removing a key barrier to its approval by NICE and making pembrolizumab combination an alternative treatment for people who cannot have atezolizumab combination.

NICE’s independent appraisal committee also agreed that the pembrolizumab combination meets the higher cost-effectiveness threshold for life-extending treatments for people with a short life expectancy.

Given by injection every 3 weeks, pembrolizumab (also called Keytruda and made by Merck Sharp and Dohme) is a type of immunotherapy that specifically targets triple negative breast cancer. It 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.

Helen Knight, interim director of medicines evaluation at NICE, said: “The recent decision demonstrates how NICE is at the forefront of bringing better care to more people. I am pleased the company has been able to work constructively with us to find solutions to the issues highlighted in our previous draft guidance.

“People who were not able to access atezolizumab, another NICE-recommended immunotherapy, now have an important new option that can help them live longer and spend more precious time with their loved ones. So, although our recommendation is for a narrower population than pembrolizumab combination is licensed for, it means the maximum number of people with advanced triple negative breast cancer now have access to effective treatments.”

Health and Social Care Secretary Sajid Javid said:

“Spending more time with friends and family following a cancer diagnosis can provide support and comfort. That is why I’m really proud the NHS can offer these types of innovative treatments and give people that extra time.

“I want to revolutionise our cancer care to make it the best in Europe, and I will set this out in my 10-Year Cancer Plan this summer.

“If you have any concerns about symptoms – the earlier you are diagnosed the sooner you can start treatment and the better the outcome so please do come forward and speak to your GP.”

Minister for Women’s Health Maria Caulfield said:

“I’m pleased this new drug will be offered on the NHS, giving breast cancer patients more time to spend with loved ones.

 “We are constantly looking for innovative treatments and new ways of working to improve diagnosis and care for cancer patients, and this is one of 12 new breast cancer treatments made available in England in the past four years.

“Later this summer we will set out our 10-Year Cancer Plan, with a renewed focus on early diagnosis, innovative ways of working, and new treatments.”

The company estimates that the pembrolizumab combination will now be available to around 100 people a year with triple negative breast cancer that has spread to other parts of the body.

NICE has made positive recommendations in all 11 of its completed appraisals of breast cancer medicines since March 2018. On completion of this appraisal that number will be 12. These are all now available for clinicians to use in the treatment of NHS patients.

The draft guidance on pembrolizumab combination for advanced triple negative breast cancer is available here -

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