Treatment with avelumab plus axitinib in people …...is a type of cancer that starts in the liver....
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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. More information can be found in the scientific abstract of this study, which you can access here: https://meetinglibrary.asco.org/record/ 173301/abstract The study drugs are not approved to treat the condition under study that is discussed in this summary. 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. Please note that this summary only contains information from the full scientific abstract: https://meetinglibrary.asco.org/record/173301/abstract Treatment with avelumab plus axitinib in people with advanced liver cancer Date of summary: May 2019 Study number: NCT03289533 | Study start date: September 2017 | Estimated study end date: October 2019 The full title of this abstract is: First-line avelumab + axitinib in patients with advanced hepatocellular carcinoma: results from a phase 1b trial (VEGF Liver 100) Avelumab <a-VEL-yoo-mab> Axitinib <AK-sih-TIH-nib> Hepatitis <HEH-puh-TY-tis> Hypertension <HY-per-TEN-shun> Hyperthyroidism <HY-per-THY-roy-dih-zum> Hypothyroidism <HY-poh-THY-roy-dih-zum> Hepatocellular carcinoma <heh-PA-toh-SEL-yoo-ler KAR-sih-NOH-muh> What did this study look at? 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/173301/abstract The researchers used 2 different guidelines to estimate people’s response to treatment: • Guideline 1 measures how much a tumor has shrunk. • Guideline 2 measures how much a tumor has shrunk and how many of the cells in the tumor have died. This guideline uses a more detailed scan of the liver to estimate people’s response to treatment. Avelumab is a study treatment for people with advanced HCC. • 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 correctly, which releases the ‘brakes’ on the immune system. This may help the body’s own immune system to destroy cancer cells. Advanced hepatocellular carcinoma (HCC for short) is a type of cancer that starts in the liver. • Advanced means that the cancer has spread within the liver (known as locally advanced) or has spread to other parts of the body (known as metastatic). Axitinib is a study treatment for people with advanced HCC. • Axitinib may reduce the number of new blood vessels that form within the cancer. This can slow the cancer’s growth or kill the cancer cells. Researchers are interested in using these drugs together because they work in different but complementary ways. In other words, researchers want to find a treatment that offers the best of both drugs. This study is looking at the efficacy and safety of avelumab + axitinib in people with advanced HCC who have not received any previous treatment. • Efficacy is how well a drug works in a clinical trial. This summary describes the results so far from this ongoing study. 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 10017 Phone (United States): +1 212-733-2323 Merck KGaA Frankfurter Strasse 250 Darmstadt, 64293, Germany Phone (Germany): +49 6151 720 Further information For more information on this study, please visit: https://meetinglibrary.asco.org/record/173301/abstract https://clinicaltrials.gov/ct2/show/NCT03289533 For more information on clinical studies in general, please visit: https://www.clinicaltrials.gov/ct2/about-studies/learn http://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. People with previously untreated advanced hepatocellular carcinoma were included in the interim analysis. People had: years An average age of 69 months Been in the study for at least (as of August 1, 2018) 6 Taken avelumab plus axitinib for an average of weeks 20 At least 1 tumor whose size could be measured tumor 1 22 Guideline 1 Efficacy Guideline 2 Guideline 1 Guideline 2 The tumor shrank in: 73% 68% The tumor completely disappeared or shrank by at least 30% in: 32% 14% On average, people lived with HCC without it getting worse for: months months 4 6 Treatment stopped HCC getting worse for at least 6 months in: 31% 35% 0 0 0 0 Safety The most common serious medical problems* related to the study treatment were: of people had persistently high blood pressure (hypertension) 50% of people had pain, swelling, numbness, sensitivity or redness of the hands or feet (hand-foot syndrome) 23% The most common medical problems related to the immune system were: of people had an underactive thyroid gland (hypothyroidism) 32% of people had an overactive thyroid gland (hyperthyroidism) 14% Nobody had medical problems related to the immune system that were considered serious. Nobody stopped taking the study treatment due to related medical problems. *Medical problems could be caused by reasons not related to the study (for example, caused by an underlying disease or by chance). Or, medical problems could have been caused by a study treatment, or by another medicine the participant was taking. A medical problem is considered “serious” when it is life-threatening, needs hospital care, or causes lasting problems. What were the main conclusions reported by the researchers? In this study, avelumab + axitinib may be an effective treatment for some people with advanced HCC, but researchers need to study this further. The medical problems seen in this study are similar to those from other studies when people received either avelumab or axitinib as separate treatments. Download Print View ASCO Scientific Abstract
Transcript of Treatment with avelumab plus axitinib in people …...is a type of cancer that starts in the liver....
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.
More information can be found in the scientific abstract of this study, which you can access here: https://meetinglibrary.asco.org/record/173301/abstract
The study drugs are not approved to treat the condition under study that is discussed in this summary.
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/173301/abstract
Treatment with avelumab plus axitinib in people with advanced liver cancer
Date of summary: May 2019Study number: NCT03289533 | Study start date: September 2017 | Estimated study end date: October 2019
The full title of this abstract is: First-line avelumab + axitinib in patients with advanced hepatocellular carcinoma: results from a phase 1b trial (VEGF Liver 100)
Avelumab <a-VEL-yoo-mab>
Axitinib <AK-sih-TIH-nib>
Hepatitis <HEH-puh-TY-tis>
Hypertension <HY-per-TEN-shun>
Hyperthyroidism <HY-per-THY-roy-dih-zum>
Hypothyroidism <HY-poh-THY-roy-dih-zum>
Hepatocellular carcinoma<heh-PA-toh-SEL-yoo-ler KAR-sih-NOH-muh>
What did this study look at?
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/173301/abstract
The researchers used 2 di�erent guidelines to estimate people’s response to treatment:• Guideline 1 measures how much a tumor has shrunk.• Guideline 2 measures how much a tumor has shrunk and how many of the cells in the tumor have died. This guideline
uses a more detailed scan of the liver to estimate people’s response to treatment.
Avelumab is a study treatment for people with advanced HCC.• 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 correctly, which releases the ‘brakes’ on the immune system. This may help the body’s own immune system to destroy cancer cells.
Advanced hepatocellular carcinoma (HCC for short) is a type of cancer that starts in the liver. • Advanced means that the cancer has spread within
the liver (known as locally advanced) or has spread to other parts of the body (known as metastatic).
Axitinib is a study treatment for people with advanced HCC. • Axitinib may reduce the number of new blood vessels
that form within the cancer. This can slow the cancer’s growth or kill the cancer cells.
Researchers are interested in using these drugs together because they work in di�erent but complementary ways. In other words, researchers want to find a treatment that o�ers the best of both drugs.
This study is looking at the e�cacy and safety of avelumab + axitinib in people with advanced HCC who have not received any previous treatment.• E�cacy is how well a drug works in a clinical trial.
This summary describes the results so far from this ongoing study.
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/173301/abstracthttps://clinicaltrials.gov/ct2/show/NCT03289533
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.
People with previously untreated advanced hepatocellular carcinoma were included in the interim analysis.
People had:
years
An average age of
69months
Been in the study for at least
(as of August 1, 2018)
6
Taken avelumab plus axitinib for an average of
weeks
20
At least 1 tumor whose size could be measured
tumor
1
22
Guideline 1
E�cacyGuideline 2 Guideline 1 Guideline 2
The tumor shrank in:
73%68%
The tumor completely disappeared or shrank by at least 30% in:
32%14%
On average, people lived with HCC without it getting worse for:
months months
46
Treatment stopped HCC getting worse for at least 6 months in:
31%35%
0
00
0
SafetyThe most common serious medical problems* related to the study treatment were:
of people had persistently high blood pressure (hypertension)50%
of people had pain, swelling, numbness, sensitivity or redness of the hands or feet (hand-foot syndrome)
23%
The most common medical problems related to the immune system were:
of people had an underactive thyroid gland (hypothyroidism)32% of people had an overactive
thyroid gland (hyperthyroidism)14%
Nobody had medical problems related to the immune system that were considered serious.
Nobody stopped taking the study treatment due to related medical problems.
*Medical problems could be caused by reasons not related to the study (for example, caused by an underlying disease or by chance). Or, medical problems could have been caused by a study treatment, or by another medicine the participant was taking.A medical problem is considered “serious” when it is life-threatening, needs hospital care, or causes lasting problems.
What were the main conclusions reported by the researchers?
In this study, avelumab + axitinib may be an e�ective treatment for some people with advanced HCC, but researchers need to study this further.
The medical problems seen in this study are similar to those from other studies when people received either avelumab or axitinib as separate treatments.
Download Print View ASCO Scientific Abstract
