Background: In India, access to curative therapies for relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) remains limited due to restricted availability of allogeneic transplants and monoclonal antibodies. Talicabtagene autoleucel (Tali-cel), a CD19-directed humanized CAR-T cell therapy, was recently approved as the first commercial CAR-T therapy in India and is priced at nearly one-tenth the cost of similar U.S. therapies. Early intervention with Tali-cel may reduce treatment-related toxicity and healthcare resource utilization (HCRU), offering an affordable therapeutic option in resource-constrained settings. We present real-world data on the clinical outcomes, safety, and HCRU associated with early vs. late use of Tali-cel.

Methods: This retrospective real-world study included 118 patients with r/r B-ALL who received Tali-cel between November 2023 and May 2025 in India. Patients were stratified based on timing of relapse: early treatment (first or second relapse) vs. late treatment (≥ third line failure). Clinical efficacy was assessed by bone marrow morphology and flow cytometry, per NCCN guidelines v2.2024.Disease response was assessed at regular intervals typically at day 28, month 3(M3), month 6(M6), month 9(M9), month 12(M12) and annually for 5 years. Progression-free survival (PFS) was analysed using Kaplan–Meier method. Safety outcomes included adverse events of special interest such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), immune effector cell–associated hemophagocytic syndrome (IEC-HS), hypogammaglobulinemia, and cytopenias —graded per ASTCT criteria. HCRU was accessed by hospital length of stay, ICU admission, clinical management of toxicities. Cost estimates were derived from institutional billing and resource use models of public sector tertiary cancer centre in India.

Results: A total of 118 patients with r/r B-ALL received tali-cel, of whom 81 patients were treated in early treatment (defined as first or second relapse) and 37 patients in late treatment (≥ third line). Baseline characteristics were well balanced between groups: median age (24 vs. 26 years), male gender (78% vs. 74%), and disease burden at apheresis (3% vs. 2% blasts).

Patients treated in early treatment demonstrated significantly better clinical outcomes. The patients with early treatment had overall response rates (ORR) of 93% and 86% at M1 and M3 post tali-cel infusion; in contrast to the late treatment group with 81% and 56% respectively. Estimated PFS at 6 months favoured early treatment (88% vs. 70%), indicating more chances of durable disease control.

Early treatment was associated with fewer severe adverse events. ICANS occured in occurred in 6% of early vs. 16% of late patients; with Grade 3-4 incidence in 3% vs. 8%, respectively. Rates of cytopenias were comparable (69% in both groups), as were Grade 3-4 CRS (7% vs. 8%), IEC-HS (22% vs. 18%) and hypogammaglobulinemia (52% vs. 46%).

Early treatment significantly reduced health care resource use. Median hospital stay was 6 days in early vs. 12 days in late group (p<0.01). ICU admissions were markedly lower (3% vs. 22%, p<0.01) and ICU stay shorter (median 2 vs. 9 days, p<0.05). Supportive care requirements were reduced: vasopressor use (5% vs. 8%) and corticosteroids (7% vs. 39%, p<0.01) were both lower with early use. Utilization of tocilizumab (72% vs. 62%), anakinra (26% vs. 24%), and IVIG (49% vs. 54%) was similar between groups, reflecting consistent supportive management.

Cost modelling revealed a 60% reduction in median hospitalization costs for early-relapse patients, driven by shorter hospital stay, less ICU need, and fewer high-grade toxicities requiring intensive management.

Conclusion: In this real-world cohort, patients with early relapse r/r B-ALL treated with tali-cel achieved more durable responses, with higher remission rates and longer progression-free survival compared to those treated later in the disease course. Importantly, early use was associated with lower toxicity, reduced healthcare resource utilization, and a significant reduction in overall cost of care. These findings suggest that early intervention with Tali-cel represents a potentially cost-effective treatment strategy, especially in resource-limited healthcare settings.

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2025
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