Real-World Patient Outcomes with Blinatumomab and Inotuzumab in Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia: A Retrospective Analysis from Two Romanian Oncology Centers

Ion Antohe^1,2Amalia Titieanu^1,2Vlad Andrei Cianga^1,2*Cosmin Minciună^1,2Cătălin Dănăilă^1,2Alina Daniela Tanase³Iuliu Ivanov¹Loredana Dragoș¹Mihaela Zlei¹Mihaela Mentel¹Ciprian Tomuleasa⁴Anamaria Bancos⁴Manuela Ciocoiu²Angela Dăscălescu^1,2

• ¹Regional Institute of Oncology (IRO), Iasi, Romania
• ²Universitatea de Medicina si Farmacie Grigore T Popa lasi, Iași, Romania
• ³Institutul Clinic Fundeni, Bucharest, Romania
• ⁴Universitatea de Medicina si Farmacie Iuliu Hatieganu Facultatea de Medicina, Cluj-Napoca, Romania

The management of adult relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) remains a significant challenge, with patients presenting particularly poor historical outcomes. Novel immunotherapies, such as Blinatumomab and Inotuzumab, have revived the therapeutic landscape of R/R B-ALL, but their optimal sequencing, toxicity management, and post-transplant integration remain unclear, particularly in real-world, resource-limited settings. We conducted a retrospective analysis of 33 adult patients with R/R B-ALL treated between 2019 and 2023 at two major oncology centers in Romania. Blinatumomab and Inotuzumab achieved complete remission rates of 47.6% and 90%, respectively, with measurable residual disease negativity in over 60% of responders. Inotuzumab was more effective in early relapses and cases with high disease burden, while Blinatumomab showed benefit in later relapses and post-transplant settings. Eleven patients were successfully bridged to allogeneic stem cell transplant, and four were treated for post-transplant relapse, demonstrating the feasibility of immunotherapy in both contexts. Sequential monoclonal antibody use yielded poor survival unless used as a bridge to curative therapy. Our findings emphasize the need for individualized treatment selection, rational immunotherapy sequencing, and the development of predictive biomarkers to optimize outcomes and minimize toxicity. Further studies are needed to refine therapeutic algorithms and define such prognostic biomarkers, particularly in underfunded healthcare systems.