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. 2025 Sep;14(18):e71230.
doi: 10.1002/cam4.71230.

Real-World Data on Inotuzumab Ozogamicin for Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia: A GRELAL-Chile Study

Marcela Espinoza  1 , Jorge Rojas-Vallejos  2 , Nicolás Rodríguez  3 , Gonzalo Guerrero  4 , Miguel López  5 , Natalia Aranguiz  5 , Guillermo Conte  6 , Francisco Samaniego  6 , Nicolás Quinteros  7 , Daniel Astete  7 , Lucas Carcamo  8 , Constanza Flores  9 , Ximena Huerta  10 , Mauricio Chandía  11 , Jorge Valenzuela  12 , Marcelo Navarrete  13 , Yorman Flores  14 , Agatha Larrazabal  15 , Edgar Zapata  15 , Joaquín Jerez  16
Affiliations

Real-World Data on Inotuzumab Ozogamicin for Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia: A GRELAL-Chile Study

Marcela Espinoza et al. Cancer Med. 2025 Sep.

Abstract

Background: Inotuzumab Ozogamicin (InO) has shown efficacy in relapsed/refractory acute lymphoblastic leukemia (R/R ALL), but evidence from Latin America is scarce. We evaluated the outcomes of Chilean patients treated with InO in public and private health centers.

Methods: We retrospectively analyzed 35 patients with R/R ALL (median age 33 years; 54% male). Twenty percent had BCR::ABL-positive ALL, 78% expressed CD22, and 91% expressed CD19. Response rates, measurable residual disease (MRD), survival outcomes, and treatment-related toxicities were assessed. Multivariate analyses explored prognostic factors.

Results: Complete remission or remission with incomplete recovery (CR/CRi) was achieved in 74% of patients. Among those evaluated, 82% reached MRD < 0.01%. Patients undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after InO had superior overall survival (OS) compared with those who did not (24.2 vs. 5.2 months). Median progression-free survival (PFS) was 6.9 months and median OS was 8.8 months. Sinusoidal obstruction syndrome occurred in 14% of patients but was generally mild. Multivariate analysis identified comorbidities and high blast counts as adverse prognostic factors, whereas MRD negativity and subsequent Allo-HSCT were associated with improved outcomes.

Conclusions: InO demonstrated high remission and MRD negativity rates in Chilean patients with R/R ALL, with OS and PFS comparable to existing research. Although SOS incidence was higher, it was generally mild. Achieving MRD negativity and proceeding to Allo-HSCT provided the greatest survival benefit. Study limitations include short follow-up and limited data.

Keywords: Inotuzumab Ozogamicin; acute lymphoblastic leukemia; sinusoidal obstruction syndrome.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Survival curves for all individuals in the sample. (a) Overall survival. (b) Progression‐free survival.
FIGURE 2
FIGURE 2
Survival curves for all individuals with CR/CRi. (a) Overall survival for MRD. (b) Overall survival for Allo‐HSCT.
FIGURE 3
FIGURE 3
Survival curves according to refractory/relapsed patients. (a) Overall survival for relapsed/refractory. (b) Progression‐free survival for relapsed/refractory.
See this image and copyright information in PMC

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