Background : Talicabtagene autoleucel (Tali-cel), a second-generation, humanized CAR-T cell therapy targeting CD19, was approved in India in October 2023 for the treatment of relapsed or refractory (r/r) B-cell malignancies. This report presents real-world data on its clinical effectiveness, safety profile, and healthcare resource requirements in patients with r/r B-cell non-Hodgkin's lymphoma (B-NHL) treated across multiple centers in India.

Methodology: We performed a retrospective review of patients aged ≥15 years with r/r B-NHL who received Tali-cel as standard-of-care (SOC). Following lymphodepleting chemotherapy, patients were infused with ≥5×10⁶ CAR-T cells/kg in a single dose. Bridging therapy was administered at the treating physician's discretion. Response was evaluated using PET-CT or CT imaging according to Lugano 2014 criteria at regular intervals typically at day 28, month 3(M3), month 6(M6), month 9(M9), month 12(M12) and annually for 5 years. Adverse events of interest—including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), immune effector cell–associated hemophagocytic syndrome (IEC-HS), cytopenias, and hypogammaglobulinemia—were graded using ASTCT guidelines. Additional outcomes such as ICU admission, hospital stay, and mortality were documented. Kaplan–Meier analysis was used to estimate progression-free survival (PFS) and overall survival (OS).

Results: From the time of approval until May 2025, 60 treatment centers across India administered Tali-cel for B-NHL. A total of 194 patients underwent leukapheresis, 170 received the CAR-T infusion, and 143 were evaluable for safety and efficacy outcome. The manufacturing success rate was 98% (191/194). Fourteen patients died prior infusion.

The median patient age was 56 years (range: 17–83), with males accounting for 64% of the cohort. Most patients had received a median of 2 prior treatment lines (range: 1–7), including polatuzumab (14%), and stem cell transplantation (4%). 23% of the patients had bulky disease (largest lesion ≥ 7cm) at enrollment and 79% received bridging therapy prior to CAR-T cell therapy. Median vein-to-vein time was 30 days (range: 16–124).

The overall response rate (ORR) was 75% and 60% and CR rate was 57% and 56%at M1 and M3 respectively. The median duration of follow-up was 5 months (range: 1–19). Six month PFS rates was 56%(95% CI: 48-66), while OS rates were 74%(95% CI: 67-83). Median PFS was 10 months, and median OS was not reached.

Most common toxicity was cytopenia with incidence of Grade 3-4 (G3-4) in 71% of the patients. Incidence of CRS was 75% (G3-4: 6%), and ICANS was 11% (G3-4: 3%) of the patients. Hypogammaglobulinemia and IEC-HS were observed in 50% and 17% of patients, respectively. Tocilizumab was administered in 63% patients who developed CRS with median dose of 1 (range 1-3). Vasopressor and Corticosteroids was required only in 6% and 8% respectively. IVIG support was required in 34% patients and anakinra for management of IEC-HS was required 75% respectively. 6% of patients required ICU-level care. The overall median hospital stay was 12 days.

Conclusion: This real-world analysis demonstrates that tali-cel is a practical, effective, and well-tolerated treatment option for r/r B-NHL in India. As the first large-scale, multicenter evaluation of this therapy in the Indian healthcare landscape, our findings support its broader implementation across various levels of clinical practice.

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2025
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