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Vol. 43. Issue S3.
Pages S34 (November 2021)
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Vol. 43. Issue S3.
Pages S34 (November 2021)
PP 03
Open Access
A REGISTRY-BASED, OBSERVATIONAL SAFETY STUDY OF INOTUZUMAB OZOGAMICIN (INO) IN PATIENTS WITH B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) PROCEEDING TO HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
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David MARKS1, Marcos DE LIMA2, Partow KEBRIAEI3, Francesco LANZA4, Christina CHO5, Sergio GIRALT5, Gizelle POPRADI6, Michael HEMMER7, Xin ZHANG8, Richa SHAH8, Verna WELCH8, Erik VANDENDRIES8, Matthias STELLJES9, Wael SABER7
1 University Hospitals Bristol
2 UH Cleveland Medical Center
3 MD Anderson Cancer Center
4 Ospedale di Ravenna
5 Memorial Sloan Kettering Cancer Center
6 McGill University Health Centre
7 CIBMTR, Medical College of Wisconsin
8 Pfizer Inc
9 Universitätsklinikum Münster
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Objective

InO is a CD22-directed antibody-drug conjugate indicated for treatment of relapsed/refractory (R/R) ALL. InO has been associated with hepatotoxicity and hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), particularly post-HSCT. Registry data from the Center for International Blood and Marrow Transplant Research (CIBMTR) was analyzed to assess toxicity in patients (pts) with ALL who received InO prior to HSCT.

Methodology

CIBMTR patient data are being collected from 2017-2022 after US approval of InO. Data accrued from 2017–2020 from 131 US adult pts (median age 40 y) treated with InO who proceeded to allogeneic HSCT were included. Using interim data at 3 y, we evaluated post-HSCT outcomes, including clinical status, overall survival (OS), non-relapse mortality (NRM), relapse, death after relapse, and investigator-defined adverse events, including hepatic VOD/SOS. All statistical analyses are descriptive.

Results

Before HSCT, 36% of pts received 1 InO cycle, 46% had 2 cycles, 17% had ≥3 cycles. Median time from last InO dose to HSCT was 2.0 mos (range: 0.4–26.2). At data lock (Nov 2020, n=131), VOD/SOS incidence within 100 d post-HSCT was 13% (18% of R/R ALL pts, n=91). Post-HSCT 12 mo OS was 55%; post-HSCT 12 mo NRM was 21%; post-HSCT 12 mo relapse was 36%; non-HSCT-related 12 mo mortality was 25%. Most pts (89%) who underwent HSCT during complete remission (CR) experienced continued CR post-HSCT.

Conclusion

Incidence of VOD/SOS after first HSCT in InO-treated pts with R/R ALL in this study was similar to the 18-19% reported in pooled analyses of 2 clinical trials among InO-treated pts with R/R ALL and in the INO-VATE study. The NRM at 1 y of 21% (23% R/R ALL) is lower than the NRM at 1 y of 38% reported in the pooled analyses of R/R ALL InO recipients. © 2021 American Society of Clinical Oncology, Inc. Reused with permission. Accepted/presented at the 2021 ASCO Annual Meeting. All rights reserved.

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Hematology, Transfusion and Cell Therapy
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