A trial comparing pembrolizumab with docetaxel for non small cell lung cancer (KEYNOTE-010)

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Results

Phase:

Phase 2/3

This trial compared pembrolizumab with docetaxel for advanced non small cell lung cancer (NSCLC). The trial was for people:

who had already had treatment for their lung cancer with a platinum chemotherapy drug
whose cancer cells produced a protein called PD-L1
whose cancer had grown into surrounding tissues or spread elsewhere in the body (advanced cancer)

More about this trial

The usual treatment for NSCLC is chemotherapy including a platinum drug such as carboplatin or cisplatin. If this doesn’t work, you might have another chemotherapy drug called docetaxel. But researchers were looking for ways to improve treatment.

In this trial, they looked at a drug called pembrolizumab (also known as MK3475). It is a type of targeted cancer drug called an immunotherapy Open a glossary item . Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells. This triggers the immune system to find and kill cancer cells.

In this trial, the researchers compared 2 different doses of pembrolizumab with docetaxel.

The aims of this trial were to:

find out how safe pembrolizumab was
find out how well it worked compared with docetaxel
learn more about the side effects

Summary of results

The trial team found that pembrolizumab increased the length of time people lived after treatment compared with docetaxel. And the side effects were manageable.

1, 034 people took part in this phase 2/3 trial. They were put into 1 of the 3 following treatment groups at random.

345 had the usual dose of pembrolizumab
346 had a higher dose of pembrolizumab
343 had docetaxel

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How long people lived

The researchers looked at the how long people lived after treatment. This is called overall survival. On average this was:

10.4 months in people who had usual dose pembrolizumab
12.7 months in people who had higher dose pembrolizumab
8.5 months in people who had docetaxel

They found pembrolizumab worked better in people who had more than half of their cancer cells positive for PD-L1. In these people, average overall survival was:

14.9 months in people who had usual dose pembrolizumab
17.3 months in people who had higher dose pembrolizumab
8.2 months in people who had docetaxel

The researchers also looked at how long people lived before the cancer started to grow again. This is called progression free survival. But they didn’t find a difference between the 3 treatment groups.

Side effects

People who had docetaxel had more serious side effects than those who had pembrolizumab. The researchers were mainly interested in immune system side effects caused by pembrolizumab. The more serious of these included:

inflammation of the walls of the lung (pneumonitis)
skin reactions such as rash or itchiness

The trial team concluded that pembrolizumab improved how long people lived after treatment. They say this finding showed it could be a new treatment option for people with advanced NSCLC whose cancer cells are positive for PD L1.

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.