Plain Language Summary
What is this summary about?
This summary describes results from a real-world study that looked at people with a type of blood cancer called acute lymphoblastic leukemia (also known as ALL). People in the study received a medicine called inotuzumab ozogamicin (also known as inotuzumab) and then received a stem cell transplant for their ALL. Researchers looked at how long people in the study lived after their transplant and how many people died for reasons related and unrelated to relapse. They also looked at how many people developed side effects, including a potentially life-threatening condition called veno-occlusive disease or sinusoidal obstruction syndrome (also known as VOD/SOS).
What were the results?
Over half the people (54%) in this study were alive 18 months after their transplant. Around 2 in 10 (22%) people died within 18 months of their transplant from reasons unrelated to relapse, and around 2 in 10 (24%) people died from reasons related to relapse.
Around 1 in 10 (14%) people in this study developed VOD/SOS within 100 days of their transplant. People who received two medicines called alkylators to prepare them for their transplant were more likely to develop VOD/SOS than those who did not.
What do the results mean?
In this real-world study, the proportion of people with ALL who developed VOD/SOS after taking inotuzumab and receiving a stem cell transplant was similar to what has been observed in clinical trials. However, fewer people in this real-world study died from reasons unrelated to relapse than in clinical trials. People who received two medicines called alkylators to prepare them for their stem cell transplant were more likely to develop VOD/SOS.
KEYWORDS: Transplantation, Hematologic/Leukemia, Hematologic, Real-world evidence, Immunotherapy
Acknowledgments
Pfizer would like to thank everyone who took part in this study.
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Disclosure statement
Marcos de Lima reports consulting or advisory roles at Amgen, Celgene, Incyte, and Pfizer, and research funding from Celgene and Pfizer. Partow Kebriaei reports consulting or advisory roles at Jazz, Kite, and Pfizer. Francesco Lanza reports consulting or advisory roles at AbbVie, Alexion, and Amgen, and research funding from Pfizer. Christina Cho reports consulting or advisory roles at AlloVir. Gizelle Popradi reports consulting or advisory roles and honoraria at AbbVie, Gilead, Kite, Kyowa Kirin, Merck, Novartis, Pfizer, Seattle Genetics, Servier and Taiho, speakers’ bureau with AbbVie, Gilead, Jazz, Merck, Novartis, PeerVoice, Pfizer, Seattle Genetics and Servier, and research funding from Jazz and Novartis. Fan Zhang, Richa Shah, Erik Vandendries, Kofi Asomaning, and Stephanie Dorman report employment at Pfizer. Richa Shah, Erik Vandendries, Kofi Asomaning and Stephanie Dorman reports stock and stock ownership interests with Pfizer. Matthias Stelljes reports honoraria, consultancy or advisory role, and research funding with Pfizer. David I Marks reports consulting and educational activities with Pfizer, Kite, and Novartis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Medical writing support was provided by Emily Balevich, PhD, from Engage Scientific Solutions, and was funded by Pfizer. Authors of the full article were involved in preparing this summary.
Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Funding
This manuscript was sponsored by Pfizer Inc.