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

Response to avelumab + axitinib or sunitinib alone in people with a rare type of 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: Efficacy and biomarker analysis of patients (pts) with advanced renal cell carcinoma (aRCC) with sarcomatoid histology (sRCC): subgroup analysis from the phase 3 JAVELIN Renal 101 trial of first-line avelumab plus axitinib (A + Ax) vs sunitinib (S)

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.
    • Sarcomatoid aRCC (sRCC for short) is a rare type of aRCC.
    • People with sRCC usually have a lower chance of survival than people with other kidney cancers.
  • Avelumab is an investigational treatment for people with aRCC. Avelumab is given by an infusion into the vein (called intravenous or IV).
    • Avelumab binds to a protein called PD-L1 on cancer cells.
    • PD-L1 tells the immune system (the body’s own 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, which may help immune cells to destroy cancer cells.

 

  • Axitinib and sunitinib are approved treatments for people with aRCC. Both are taken as tablets. Axitinib is approved for use after sunitinib or other treatments have failed.
    • These treatments may prevent the 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 + axitinib work together, compared with sunitinib by itself, in people with aRCC.
    • Even though the study is ongoing, researchers can look at results part-way through.
    • This summary focuses on results in people with sRCC.

 

  • The researchers are looking at people with sRCC treated with avelumab + axitinib together, to find out:
    • how long people live with their cancer before it gets worse, and
    • whether tumors shrink.
  • The researchers also looked at certain biological factors (known as biomarkers).
    • They compared levels of biomarkers in people with sRCC with levels in other people in the study.

Who took part in this study?

What were the results of the study?

How long did people with sRCC live without their cancer getting worse?

  • On average, people treated with avelumab + axitinib lived for longer without their cancer getting worse compared with people treated with sunitinib.
  • 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 many people had tumors that shrank?

  • On average, people treated with avelumab + axitinib were more likely to have their tumor shrink substantially than people who received sunitinib.
  • Although the results look quite different, this difference may not be meaningful. Researchers need to look at the results for a lot of people, or to see a very big difference, to be sure the results did not happen by chance.

 

How many people had tumors that disappeared completely?

  • Among people treated with avelumab + axitinib, around 4 in 100 people had tumors that disappeared completely.
  • Among people treated with sunitinib, nobody’s tumor disappeared completely.

 

Did people with sRCC have higher levels of certain biomarkers than people without sRCC?

  • Early results found that people with sRCC had higher levels of some biomarkers related to the immune system.
    • This included PD-L1, which is the target of avelumab.
    • Researchers need to do more studies before they know whether these biomarkers can help predict how well a person responds to treatment.

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

What were the main conclusions reported by the researchers?

  • The results suggest that avelumab + axitinib may be a treatment option for people with sRCC.
    • In this study, people with sRCC treated with avelumab + axitinib lived for longer without their cancer getting worse, and had a higher rate of tumor shrinkage, compared with people who received sunitinib by itself.
  • The results for people with sRCC were similar to the results of the overall study, which included people with other types of aRCC.
  • This study helped researchers to learn more about biomarkers in sRCC, but they will need to do more studies.

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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