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

Treatment with avelumab + axitinib together or sunitinib alone in Japanese people with advanced kidney cancer

Date of summary: September 2019

Study number: NCT02684006

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Study start date: March 2016

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Estimated study end date: May 2024

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The full title of this abstract is: Randomized phase 3 trial of avelumab + axitinib vs sunitinib as first-line treatment for advanced renal cell carcinoma: JAVELIN Renal 101 Japanese subgroup analysis

Sunitinib is approved to treat the condition under
study that is discussed in this summary. Axitinib is not
approved to treat the condition under study that is
discussed in this summary. Avelumab is not approved
to treat the condition under study that is discussed in
this summary. The combination of avelumab + axitinib
is not approved in Europe 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.

 

This summary reports the interim results from the
study – results may not be the same when the study
is complete.

 

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?

  • Advanced renal cell carcinoma (aRCC for short) is a type of kidney cancer.
    • Advanced means that the cancer has spread within the kidneys or to other parts of the body.
  • Avelumab is an investigational treatment for people with aRCC. Avelumab is given by an infusion into the vein (called intravenous or IV).
    • Avelumab is an antibody. It binds to a protein called PD-L1.
    • PD-L1 is found on the surface of some of the body’s cells, including some cancer cells. This protein tells the immune system (the body’s defense cells) not to attack.
    • When avelumab binds to PD-L1, it may prevent PD-L1 from working. This releases the ‘brakes’ on the immune system. This may help the body’s own immune system to destroy cancer cells.
  • Axitinib and sunitinib are both taken as tablets. They are approved treatments for people with aRCC. Axitinib is approved for use after sunitinib or other treatments have failed.
    • These treatments may prevent a cancer from forming new blood vessels. This can slow the cancer’s growth or cause cancer cells to die.
  • This ongoing study is looking at how well avelumab and axitinib work together, compared with sunitinib on its own, in people from various countries with aRCC who have not received any previous treatment.
    • Even though the study is ongoing, researchers can look at results part-way through.
    • The researchers looked separately at results for people with PD-L1-positive cancers (PD-L1+ for short).
    • They were PD-L1+ if at least 1% of immune cells in a sample from the cancer tested positive.
  • This summary describes results for Japanese people with aRCC.
    • The study looked at:
      • how long people lived with their cancer without it getting worse
      • how long people lived after starting the study
      • whether people’s tumors shrank, and
      • the most common medical problems that people had.

Who took part in this study?

What were the results of the study?

  • Researchers who are studying how long people live will always see a variety of times. To find out whether a drug is
    making a diference, they look at the average time for everyone in the study.
  • On average, Japanese people receiving avelumab + axitinib lived for 17 months and people receiving sunitinib alone
    lived for 11 months without their cancer getting worse.
  • This does not mean that everyone in that group had these results. Some people lived for longer than the average
    and others lived for a shorter time, giving a range of times either side of the average. The ranges overlapped for
    people receiving avelumab + axitinib and those receiving sunitinib alone. This means that although the average
    times can differ, this difference may not meet set levels for statistical tests.

 

How long did people live after starting the study?

 

  • In this study, Japanese people lived for the same length of time whichever treatment they had. The researchers
    cannot yet calculate the average time that people survived because most people were still alive.

 

How many people in this study had tumors that shrank?

 

  • Around 6 in 10 Japanese people receiving avelumab + axitinib had tumors that shrank substantially. Around 2 in 10
    Japanese people receiving sunitinib alone had tumors that shrank substantially.

 

What medical problems did people have, and how many were severe?

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

What was the main conclusion reported by the researchers?

  • In this study, the researchers looked at Japanese people with aRCC who received avelumab + axitinib
    together or sunitinib alone as their first treatment for aRCC.

    • Avelumab + axitinib had effects on the tumors and on how long people lived, as well
      as acceptable safety.
    • The results in Japanese people were similar to results researchers have seen for people
      from all the countries involved in the trial.

Who sponsored this study?

EMD Serono Inc.
One Technology Place, Rockland, MA 02370
Phone (United States): +1 800-283-8088

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

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

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