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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/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 different 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 treatment Date of summary: May 2019 Study 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 10017 Phone (United States): +1 212-733-2323 Further information For more information on this study, please visit: https://meetinglibrary.asco.org/record/173650/abstract https://clinicaltrials.gov/ct2/show/NCT01564784 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 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 longer if 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 InO 8 in 10 people More than Around Receiving chemotherapy 3 in 10 people For people whose cancer returned after 12 months: For people whose cancer returned after 18 months: For people receiving InO whose cancer returned after 12 months For people who received InO whose cancer returned after 18 months compared with around 12 in 100 people receiving chemotherapy 12 in 100 people 12% compared with around 12 in 100 people receiving chemotherapy for those receiving InO months 10.3 for those receiving chemotherapy months 7.7 vs for those receiving InO months 10.3 for those receiving chemotherapy months 9.5 vs 37 in 100 people 37% 46 in 100 people 46% 12 in 100 people 12% Around 13 in 100 people who received InO were found to have liver problems 13 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 effects 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 effective treatment for these people than chemotherapy. Download Print View ASCO Scientific Abstract
