Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Effect of a checkpoint inhibitor on survival in people with non-small cell lung cancer, after avelumab or docetaxel treatment

Date of summary: September 2019

Study number: NCT02395172

|

Study start date: March 2015

|

Estimated study end date: November 2019

|

The full title of this abstract is: Assessing the impact of subsequent checkpoint inhibitor (CPI) treatment on overall survival: post hoc analyses from the phase 3 JAVELIN Lung 200 study of avelumab vs docetaxel in platinum-treated locally advanced/metastatic non-small cell lung cancer (NSCLC)

This study drug is not approved to treat the condition under study that is discussed in this summary.

 

Researchers must look at the results of many types of studies to understand whether a study drug works, how it works, and whether it is safe to prescribe to patients.

This summary reports the results of only one study. The results of this study might be different from the results of other studies that the researchers look at.

 

More information can be found in the scientific abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • Non-small cell lung cancer (NSCLC for short) is the most common type of lung cancer.
    • Advanced NSCLC is cancer that may have spread from the lung to nearby tissues or more distant parts of the body.
  • Avelumab is not currently approved to treat NSCLC.
  • Avelumab is a type of immunotherapy drug called a checkpoint inhibitor, which means it uses the body’s defense (immune) system to find and destroy cancer cells. Avelumab helps to release the ‘brakes’ on the immune system so that the body’s immune cells can attack cancer cells.
    • Avelumab attaches to a protein called PD-L1, which is found on the surface of tumor cells.
    • PD-L1 ‘hides’ tumor cells from the immune system.
    • When avelumab binds to PD-L1, tumor cells are exposed. This may allow the body’s immune cells to attack and destroy the tumor cells
  • This study looked at people with advanced NSCLC who received a second treatment (called second-line therapy) because their first treatment (first-line therapy) did not work or stopped working. This study looks at how long people lived after they went on to receive:
    • avelumab or a chemotherapy drug called docetaxel as second-line therapy, and then
    • a checkpoint inhibitor as their third treatment (called third-line therapy) if their second-line avelumab or docetaxel therapy did not work or stopped working
  • The researchers also looked at other factors, such as whether people’s tumors had the PD-L1 proteins on their surface (known as PD-L1-positive tumors).
    • PD-L1-positive meant that at least 1 in 100 tumor cells had PD-L1 proteins on their surface when measured.
  • This summary looks at the people in this study who received a checkpoint inhibitor as third-line therapy. The researchers wanted to know whether the results in these people had affected the results of the study overall.

Who took part in this study?

What were the results of the study?

  • Overall this study did not achieve its main aim.
  • The researchers had expected to see that people who received avelumab would live longer than those who received docetaxel, but they actually lived for a similar length of time.
  • The researchers then tried to work out why the study did not achieve its main aim.
  • Many people who received docetaxel as second-line therapy then received a checkpoint inhibitor as third-line therapy.
  • Receiving a checkpoint inhibitor after docetaxel may have helped this group of people to live longer. This could partly explain why the researchers did not see a difference between the avelumab and docetaxel groups.

More results from this study can be found here:
View ESMO Scientific Abstract

What were the main conclusions reported by the researchers?

  • The study did not meet its main aim.
  • This study suggests that the fact that many people who received docetaxel at second-line, went on to
    receive a checkpoint inhibitor at third line may have affected the results.
  • This analysis does not alter the conclusions of this study, but can help to improve the design of studies in
    the future.

Who sponsored this study?

Pfizer Inc.
235 East 42nd Street NY, NY 10017
Phone (United States): +1 212-733-2323

EMD Serono, Inc.
An affliate of Merck KGaA, Darmstadt, Germany
One Technology Place Rockland, MA 02370
Phone (United States Headquarters): +1 800 283-8088

Pfizer would like to thank all of the
people who took part in this study.

Click to show further information on the study and clinical trials in general