ORIGINAL RESEARCH article
Front. Oncol.
Sec. Hematologic Malignancies
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1601782
A retrospective analysis of inotuzumab ozogamicin usage in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia
Provisionally accepted
- 1Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, National Capital Territory of Delhi, India
- 2Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, Andhra Pradesh, India
- 3Fortis Memorial Research Institute, Gurgaon, Haryana, India
- 4Malabar Cancer Center, Tellicherry, India
- 5Tata Medical Centre, Kolkata, West Bengal, India
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The treatment of B-cell acute lymphoblastic leukemia (ALL) in India, involves multi-agent chemotherapy and central nervous system (CNS) prophylaxis, but relapsed/refractory (R/R) Bcell ALL presents with high mortality and limited salvage options. Inotuzumab ozogamicin (InO), a monoclonal antibody targeting cluster of differentiation-22 (CD22) conjugated to calicheamicin, has improved outcomes for R/R B-cell ALL. A phase 3 multicenter trial (INO-VATE) in adult patients with CD22+ B cell ALL has shown that InO significantly increases response rates and overall survival (OS) compared to standard treatments, with ongoing studies assessing its real-world effectiveness in India.Methodology: A multicentric, retrospective, observational study was conducted across 5 oncology centers in India to evaluate the effectiveness of InO in adult patients with R/R B-cell ALL. The study aimed to assess clinical outcomes, including the rate of complete remission (CR)/CR with incomplete hematologic recovery (CRi), minimal residual disease (MRD) negativity, duration of remission (DOR), OS, as well as the safety and tolerability of InO in real-world settings.The medical records of adult patients (n = 32) aged > 18 years with R/R B cell ALL treated with InO between February 2017 -October 2022 were assessed. Amongst the total study participants 59.4% (n = 19) achieved CR/CRi. Of these responders, minimal residual disease (MRD) negativity was achieved in 94.7% (n = 18/19)). 68.4% (n = 13/19) achieved deep responses (MRD negative CR/CRi) after a median of two cycles of InO. The median DOR for those achieving CR/CRi was 6 months. Out of the entire cohort, 34.4% (11/32) of the participants proceeded to hematopoietic stem cell transplantation (HSCT). The OS rate at 6 and 12 months in the entire cohort was 46.9% and 28.1% respectively. Median relapse free survival (RFS) amongst the responders was 7 months. Grade 3/4 treatment related liver toxicity following InO initiation was reported in 37.5% of the participants. Myelosuppression related adverse events were observed in 87.5% recipients.The real-world study (RWS) highlights the effectiveness of InO in achieving remission and MRD negativity in R/R B-cell ALL, although treatment-related toxicities remain a concern.
Keywords: B-cell acute lymphoblastic leukemia, Inotuzumab ozogamicin, CD22, Antibodydrug conjugate, HSCT
Received: 28 Mar 2025; Accepted: 24 Jul 2025.
Copyright: © 2025 Agrawal, Boyella, Bhargava, Nair and Nag. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Arijit Nag, Tata Medical Centre, Kolkata, 700135, West Bengal, India
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