A trial comparing MK3475 with chemotherapy for non small cell lung cancer

Cancer type:

Lung cancer

Non small cell lung cancer

Secondary cancers

Status:

Results

Phase:

Phase 3

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.

More about this trial

Doctors usually use a combination of the following chemotherapy drugs to treat non small cell lung cancer (NSCLC) that had spread:

This is standard treatment. Open a glossary item 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:

how well pembrolizumab worked for people with non small cell lung cancer
how safe pembrolizumab was
more about the side effects
how pembrolizumab affected people’s quality of life

Summary of results

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.

154 people had pembrolizumab
151 people had chemotherapy

12770_1.png

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:

just over 10 months (10.3) for those who had pembrolizumab
6 months for those who had chemotherapy

At 6 months, the number of people who were alive and had no sign of their cancer was:

89 people in the pembrolizumab group
76 people in the chemotherapy group

12770_2.png

The total number of people who were alive at 6 months was:

121 people in the pembrolizumab group
107 people in the chemotherapy group

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:

a drop in red blood cells (anaemia )
feeling sick
tiredness

The most common side effects in the pembrolizumab group were:

diarrhoea
tiredness
a high temperature

Pembrolizumab works by stimulating the immune system. So the team also looked at the number of side effects that were caused by the immune system Open a glossary item . 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:

skin reactions
inflammation of the lining of the lungs
inflammation of the lining of the bowel

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:

151 people in the pembrolizumab group
148 people in the chemotherapy group

At week 15 the researchers looked at the symptoms of lung cancer. These included:

cough
chest pain
shortness of breath

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:

significantly increases the length of time they are free of cancer
increases the overall length of time they live
has fewer side effects
improves quality of life

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 (peer reviewed Open a glossary item ) 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.