More information can be found in the scientific abstract of this study, which you can access here: https://meetinglibrary.asco.org/record/175025/abstract

Axitinib and sunitinib are 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 plus axitinib 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 di�erent from the results of other studies that the researchers look at.

Please note that this summary only contains information from the full scientific abstract:https://meetinglibrary.asco.org/record/175025/abstract

Factors to identify whether avelumab plus axitinib or sunitinib will be most e�ective for people with advanced kidney cancer

Date of summary: May 2019Study number: NCT02684006 | Study start date: March 2016 | Estimated study end date: June 2021

The full title of this abstract is: Biomarker analyses from JAVELIN Renal 101: avelumab + axitinib (A+Ax) vs sunitinib (S) in advanced renal cell carcinoma (aRCC)

Who took part in this study?

What were the results of the study?

More results from this study can be found here: https://meetinglibrary.asco.org/record/175025/abstract

In this study, most people who received avelumab + axitinib lived longer without aRCC getting worse than patients who only took sunitinib. • This was most noticeable in people whose cancer cells contained genes that help new blood vessels grow.

People responded di�erently to each treatment when their tumors had rare mutations in the following genes:• PTEN, which helps prevent healthy cells from becoming cancer cells• DNMT1, which helps control how quickly cells start to divide to form exact copies of themselves• CD1631L, which is found in the body’s immune cells.

The researchers looked at tumor samples from 866 people with aRCC.

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

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

Merck KGaAFrankfurter Strasse 250Darmstadt, 64293, GermanyPhone (Germany): +49 6151 720

Further information

For more information on this study, please visit:https://meetinglibrary.asco.org/record/175025/abstracthttps://clinicaltrials.gov/ct2/show/NCT02684006

For more information on clinical studies in general, please visit:

https://www.clinicaltrials.gov/ct2/about-studies/learnhttp://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are

Abstract Plain Language Summary writing support was provided by Leon Adams, PhD, Envision Pharma Group, Inc. and was funded by Pfizer.

What were the main conclusions reported by the researchers?

This study provides information on biological factors, such as certain proteins and genes, which may help predict how well people will respond on di�erent aRCC treatments.

This may help doctors to identify which treatment will be most e�ective for each person with aRCC.

Avelumab <a-VEL-yoo-mab>

Axitinib <AK-sih-TIH-nib>

Sunitinib <soo-NIH-tih-nib>

Renal cell carcinoma <REE-nul sel KAR-sih-NOH-muh>

What did this study look at?

Avelumab is a study treatment for people with aRCC.• Avelumab binds to a protein called PD-L1.

– PD-L1 tells immune cells not to attack cancer cells.

• When avelumab binds, it may prevent PD-L1 from working, which releases the ‘brakes’ on the immune system. This may help the body’s own immune system to destroy cancer cells.

This ongoing study is looking at how well avelumab and axitinib work together, compared with sunitinib by itself, in people with aRCC.

Advanced renal cell carcinoma (aRCC for short) is a type of kidney cancer.• Advanced means that the cancer has spread

within the kidneys (known as locally advanced) or has spread to other parts of the body (known as metastatic).

Axitinib and sunitinib are approved treatments for people with aRCC.• These treatments may reduce the number of new

blood vessels from forming in the cancer. This can slow the cancer’s growth or cause cancer cells to die.

This summary describes certain biological factors (known as biomarkers) that might help identify which people with aRCC are more likely to survive. These factors are as follows:• The protein PD-L1• Certain genes that a�ect:

– blood vessel growth– how much certain types of white blood cells

(T-cells) get into tumors, and– switching on an immune response.

886

These people had not received any treatment for aRCC before

received avelumab + axitinib

received sunitinib

Tumor samples were tested for specific proteins and genes

People lived longer with aRCC without it getting worse when they:

Cancer cells contained the PD-L1 protein

received avelumab + axitinib

received sunitinib

Cancer cells used genes thathelp the growth of newblood vessels

Cancer cells did not havethe PD-L1 protein

The total number of changes in cancer cell genes did not a�ect how long people lived with aRCC without it getting worse for either treatment

Cancer cells used genes that help high numbers of certainwhite blood cells (T-cells) get inside tumors

Cancer cells used genes that help switch on an immune response

Download Print View ASCO Scientific Abstract