Impact of salvage treatment phase on inotuzumab ozogamicin treatment for relapsed/refractory acute lymphoblastic leukemia: an update from the INO-VATE final study database

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Acknowledgements

This study was sponsored by Pfizer. Medical writing support was provided by Susan Tan, PhD, of Engage Scientific Solutions, and was funded by Pfizer. The first draft of this manuscript was based on poster PS950 presented at the 24th Congress of the European Hematology Association (EHA), 2019, and poster 7029 presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, 2019.

Disclosure statement

EJ has received research grants and consultancy fees from AbbVie, Adaptive Biotechnologies, Amgen, Bristol-Myers Squibb, Pfizer, and Takeda. MS declares research support and honoraria from Pfizer. ASA declares research funding and honoraria from Pfizer, research funding from Amgen, and honoraria from AbbVie and Kite Pharmaceuticals. DJD declares honoraria from Pfizer. NG declares research support and honoraria from Amgen, Novartis, and Pfizer. DIM declares consultancy with Pfizer. WS declares research funding and honoraria from Pfizer, honoraria from Research to Practice and Up to Date, and has served on advisory boards for Agios, Astellas, and Kite Pharmaceuticals. SO declares research support from Acerta, Kite Pharmaceuticals, and Regeneron; research support and consultancy from Gilead, Pfizer, Pharmacyclics, Sunesis, and TG Therapeutics; and consultancy from AbbVie, Alexion, Amgen, Aptose Biosciences Inc., Astellas, Celgene, Eisai, GlaxoSmithKline, Janssen Oncology, Vaniam Group LLC, and Verastem. RDC has received research support from Amgen, Incyte, Kite/Gilead, Merck, Pfizer, and Vanda Pharmaceuticals; has received personal fees from Amgen and Pfizer; and has a spouse who is an employee of Seattle Genetics. TW, AN, and EV are employees of and own stock in Pfizer. HK has received research support and honoraria from AbbVie, Agios, Amgen, Immunogen, and Pfizer; has received research support from Ariad, Astex, Bristol-Myers Squibb, Cyclacel, Daiichi-Sankyo, Jazz Pharmaceuticals, and Novartis; has served on advisory boards for Actinium; and has received honoraria from Takeda.

Data availability statement

Upon request, and subject to certain criteria, conditions and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual deidentified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the United States and/or European Union, or (2) in programs that have been terminated (i.e. development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The deidentified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.