
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This trial compared pembrolizumab (MK3475) with chemotherapy for non small cell lung cancer that had spread to another part of the body.
It was for people whose cancer cells had large amounts of a protein called PD-L1 on their surface. This is called PD-L1 positive cancer.
This trial was open for people to join between September 2014 and October 2015. The results were published in 2016 and 2017.
Doctors usually use a combination of the following chemotherapy drugs to treat non small cell lung cancer (NSCLC) that had spread:
This is It works but researchers are always looking for better treatments.
Pembrolizumab is an immunotherapy drug. It helps cells in the immune system to attack cancer cells.
In this trial, the researchers compared pembrolizumab with the standard treatment for lung cancer that had spread.
The aims were to find out:
The trial team found that pembrolizumab worked well for non small cell lung cancer when at least half (50%) of the cancer cells have PD-L1. They say that pembrolizumab might be a good first treatment for this group of people.
About this trial
This was a phase 3 trial. It was a randomised trial.
The 305 people who took part were put into 1 of 2 groups. Neither they nor their doctor chose which group they were put in.
Results
The average follow up was just over 11 months (11.2 months). The team compared the average length of time people were alive and had no sign of their cancer. They found it was:
At 6 months, the number of people who were alive and had no sign of their cancer was:
The total number of people who were alive at 6 months was:
Side effects
Twice as many people in the chemotherapy group had serious side effects than people in the pembrolizumab group.
More people who had chemotherapy stopped treatment than people who had pembrolizumab.
The most common side effects in the chemotherapy group were:
The most common side effects in the pembrolizumab group were:
Pembrolizumab works by stimulating the immune system. So the team also looked at the number of side effects that were caused by the . They found that more people in the pembrolizumab group had these type of side effects than those in the chemotherapy group.
The most serious immune side effects reported by people in the pembrolizumab group were:
Quality of life
Of the 305 people who took part, 299 people completed the quality of life questionnaires. The number of people in each group that completed the questionnaires was:
At week 15 the researchers looked at the symptoms of lung cancer. These included:
They found that fewer people in the pembrolizumab group reported these symptoms getting worse than those in the chemotherapy group.
Of the 151 people in the pembrolizumab group, 46 people (31%) reported worse symptoms. Of the 148 people in the chemotherapy group, 58 people (39%) reported their symptoms were worse.
The researchers found the average length of time it took for the symptoms of lung cancer to get worse was longer for people in the pembrolizumab group.
Conclusion
The trial team concluded that pembrolizumab worked for people with NSCLC when at least half (50%) of cancer cells have PD-L1. Compared to chemotherapy, pembrolizumab:
This means that pembrolizumab might be a good initial treatment (first line treatment) for NSCLC with cells that have PD-L1.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Christian Ottensmeier
Experimental Cancer Medicine Centre (ECMC)
Merck Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.