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/173650/abstract

This study drug is 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.

Who took part in this study?

More results from this study can be found here: https://meetinglibrary.asco.org/record/173650/abstract

Treatment for ALL aims to kill the cancer cells in the blood and bone marrow. • If cancer cells disappear after treatment and later

return, this is called relapsed ALL.• If some cancer cells are still present after

treatment, this is called refractory ALL.

What were the results of the study?

In this study, researchers reported the results for people whose cancer returned after 12 months, and for people whose cancer returned after 18 months.After treatment, the cancer was undetectable for people:

Results were similar for both populations (cancer returned after 12 months and 18 months).

Please note that this summary only contains information from the full scientific abstract:https://meetinglibrary.asco.org/record/173650/abstract

Inotuzumab ozogamicin compared with chemotherapy in people with acute lymphoblastic leukemia whose cancer returned after being undetectable for more than 1 year after their first treatmentDate of summary: May 2019Study number: NCT01564784 | Study start date: August 2012 | Study end date: January 2017

The full title of this abstract is: Inotuzumab Ozogamicin (InO) treatment in patients with relapsed/refractory acute lymphoblastic leukemia (R/R ALL): Outcomes of patients treated in salvage one with a long duration of first remission

Pfizer 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

Further information

For more information on this study, please visit:

https://meetinglibrary.asco.org/record/173650/abstracthttps://clinicaltrials.gov/ct2/show/NCT01564784

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 Philip Matthews, PhD, CMPP, Envision Pharma Group, Inc. and was funded by Pfizer.

What were the main conclusions reported by the researchers?

In this study, people whose ALL returned following successful treatment with their first therapy for more than 1 year were more likely to: – achieve undetectable disease – live longerif they received InO rather than chemotherapy.

People received InO

People received chemotherapy

40

48

88

Adults whose cancer returned 18 months or more after their first treatment was successful

Adults whose cancer returned 12 months or more after their first treatment was successful

People received InO

People received chemotherapy

28

31

59

Receiving InO8

in 10 people

Morethan Around

Receiving chemotherapy3

in 10people

For people whose cancerreturned after 12 months:

For people whose cancerreturned after 18 months:

For people receiving InO whose cancer returned after 12 months

For people who received InO whose cancerreturned after 18 months

compared with around 12 in 100 people receiving chemotherapy

12 in 100 people12%

compared with around 12 in 100 people receiving chemotherapy

for thosereceiving InO

months

10.3for those receivingchemotherapy

months

7.7vsfor thosereceiving InO

months

10.3for those receivingchemotherapy

months

9.5vs

37 in 100 people37%

46 in 100 people46%

12 in 100 people12%

Around 13 in 100 people who received InO were found to have liver problems13 in 100 people

13%

The average time that people lived for was:

The number of people likely to survive to 2 years was:

ALL<A-ell-ell>

Lymphoblastic leukemia <LIM-foh-BLAS-tik loo-KEE-mee-ah>

Refractory <reh-FRAK-tor-ee>

Relapsed <REE-lapst>

Inotuzumab ozogamicin<ih-noh-TOO-zoo-mab OH-zoh-ga-MIH-sin>

What did this study look at?

Acute lymphoblastic leukemia (ALL for short) is a type of cancer of the blood and bone marrow. Bone marrow is the area inside of bones where blood cells develop.• In people with ALL, the bone marrow makes

abnormal versions of immature white blood cells. These divide rapidly and spread throughout the body.

Inotuzumab ozogamicin (InO for short) is a treatment for people with relapsed or refractory ALL.• Many ALL cancer cells have a protein called CD22 on

their surfaces.• InO attaches to CD22, gets taken up by the cancer

cells, and causes them to die.

In this study (called the INO-VATE study), researchers compared the e�ects of InO and chemotherapy in people with relapsed or refractory ALL.• This study only involved adults.

This summary looks at people in the INO-VATE study who had InO or chemotherapy when their cancer returned after being undetectable for more than 1 year after their first therapy for ALL.

The researchers wanted to know if InO is a more e�ective treatment for these people than chemotherapy.

Download Print View ASCO Scientific Abstract