Early use of talicabtagene autoleucel in r/r B-acute lymphoblastic leukemia is cost-effective: Improved efficacy, reduced toxicity and healthcare resource utilization support affordable access

Abstract 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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Blood
Published
2025-11-03
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https://doi.org/10.1182/blood-2025-1076
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CAR-T cell therapy research
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article

Early use of talicabtagene autoleucel in r/r B-acute lymphoblastic leukemia is cost-effective: Improved efficacy, reduced toxicity and healthcare resource utilization support affordable access

Suvir Singh, J. K., Anil Aribandi, Monisha Harimadhavan et al.
Blood
CAR-T cell therapy research
article

Early use of talicabtagene autoleucel in r/r B-acute lymphoblastic leukemia is cost-effective: Improved efficacy, reduced toxicity and healthcare resource utilization support affordable access

Suvir Singh, J. K., Anil Aribandi, Monisha Harimadhavan, Sameer Ramesh Melinkeri, Yogesh Yadav, Rajasekar Thirugnanam, Rajan Kapoor, Atharva Karulkar, Terry J. Fry, Hasmukh Jain, Jayshree Thorat, Abhijith Murali, Nitin Jain, Sakshi Soni, Sanket Shah, Afrin Firfiray, Rumesh Chandar, Vasu Babu Goli, Nirali N. Shah, Lingaraj Nayak, Chandran K. Nair, Vikram Mathews, Esha Kaul, Namita Tiwari, Anjali Jaiswal, Rahul Purwar, Sameer Tulpule, Moumita Basu, Smrithi Ravikumar, Akshay Lahoti, Bhausaheb Bagal, Anupam Chakrapani, Juber Pendhari, Kripa Bajaj, Sunil Kumar Gupta, Shalini Purwar, Hari Menon, Dinesh Bhurani, Krishna Reddy Golamari, Rakesh Reddy Boya, Velu Nair, S.K. Sahay, Punit Jain, Soumendra Darbar, Padmaja Lokireddy, Nishad Gajanan Dhakate, Rajat Bhattacharyya, Anshul Gupta, Priyanka Samal, Mohammed Sadique Ansari, Rahul Bhargava, Kannan Subramanian, Manju Sengar, Alok Shetty, Sharat Damodar, Rajat Bajaj, Nataraj KS, Pavan Kumar Boyella, P. K. Mehta, Girish Badarkhe, Shreshtha Shah, Ashish Saroha, Anand Vaibhaw, Devanshi Kalra, Prakash Shekhawat, Manivasagam Sundharam, Neeraj Siddarthan, Suraj Chiraniya, Ram Abhinav, Supriya Chawkekar, Balakrishna Padate
article en

Abstract

Abstract 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.

BloodVol. 146(Supplement 1)
Amrita Institute of Medical Sciences and Research Centre (IN), Malabar Cancer Centre (IN), Apollo Hospitals (IN), The University of Texas MD Anderson Cancer Center (US), Gujarat Cancer & Research Institute (IN), Indian Institute of Technology Bombay (IN), Christian Medical College, Vellore (IN), University of Colorado Boulder (US), Homi Bhabha National Institute (IN), Sir H.N. Reliance Foundation Hospital and Research Centre (IN), Government Vellore Medical College (IN), Mahatma Gandhi Memorial Medical College (IN), Cancer Institute (WIA) (IN), University of Colorado System (US), Max Super Speciality Hospital (IN), CARE Hospitals (IN), Narayana Health (IN), Topiwala National Medical College & BYL Nair Charitable Hospital (IN), Shree Guru Gobind Singh Tricentenary University (IN), Dayanand Medical College & Hospital (IN), Rajiv Gandhi Cancer Institute and Research Centre (IN), Vedanta Resources (India) (IN), Regional Centre for Biotechnology (IN), Basavatarakam Indo American Cancer Hospital and Research Institute (IN), Kovai Medical Center and Hospital (IN), Bhagwan Mahaveer Cancer Hospital and Research Centre (IN), HCG Cancer Hospital (IN), Deenanath Mangeshkar Hospital and Research Center (IN), Century Health (US), Cancer Hospital and Research Institute (IN), Afrihealth Optonet Association (NG), BLK Super Speciality Hospital (IN), Apollo Hospitals (IN), Kokilaben Dhirubhai Ambani Hospital (IN), Institute of Medical Sciences and Sum Hospital (IN), HCG Cancer Centre (IN), National Cancer Institute (US), HCG NCHRI Cancer Centre (IN), St.John's Medical College Hospital (IN), Asha Hospital (IN), Apollo Hospitals (IN), Sahyadri Hospital (IN), Manipal Hospital (IN), Army Hospital Research and Referral (IN), University of Colorado Denver (US)
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