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
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.
Article Details
Authors (72)
Atharva Karulkar
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Hasmukh Jain
11Hematolymphoid Unit, Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Devanshi Kalra
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Smrithi Ravikumar
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Anand Vaibhaw
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Shreshtha Shah
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Afrin Firfiray
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Juber Pendhari
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Neeraj Siddarthan
3Amrita Hospital, Kochi, Kochi, India
Pavan Kumar Boyella
9Basavatarakam Indo-American Cancer Hospital & Research Institute, Hyderabad, India
Sanket Shah
5HOC Vedanta, Ahmedabad, India
Sameer Melinkeri
6Deenanath Mangeshkar Hospital, Pune, India
Anshul Gupta
Prashant Mehta
8Amrita Hospital, Faridabad, Faridabad, India
Chandran Nair
5Malabar Cancer Centre, Thalassery, India
Dinesh Bhurani
1Rajiv Gandhi Cancer Institute and Research Centre, Delhi, India
Akshay Lahoti
11Department of Clinical Hematology, Super Speciality Hospital, MGM Medical College, Indore, India
Anupam Chakrapani
12Apollo hospital, Kolkata, India
Balakrishna Padate
13Sir HN Reliance Hospital, Mumbai, India
Prakash Shekhawat
14Bhagwan Mahavir Cancer Hospital and Research Centre, Jaipur, India
Priyanka Samal
Rajat Bajaj
16HCG Cancer Care Centre, Nagpur, India
Rumesh Chandar
17Kovai Medical Center and Hospital, Coimbatore, India
Padmaja Lokireddy
10Apollo Hospitals, Hyderabad, India
Anil Aribandi
19Sindhu Hospital, Hyderabad, India
Bhausaheb Bagal
2Tata Memorial Centre, Department of Medical Oncology, Mumbai, India
Girish Badarkhe
4SMBT Charitable Hospital, Nashik, India
Jayachandran P.K.
21Adyar (WIA) Cancer Institute, Chennai, India
Kripa Bajaj
Nataraj KS
4HCG, Bengaluru, India
Nishad Dhakate
16HCG Cancer Care Centre, Nagpur, India
Rajan Kapoor
1Army Hospital (Research & Referral), Delhi, India
Rahul Bhargava
25Fortis Hospital, Gurugram, India
Sameer Tulpule
26Kokilaben Dhirubhai Ambani Hospital, Mumbai, India
Sharat Damodar
2Mazumdar Shaw Medical Centre, Narayana Health City, Bengaluru, India
Sunil Gupta
28Continental Hospitals, Hyderabad, India
Suraj Chiraniya
29Dr. LH Hiranandani Hospital Powai, Mumbai, India
Suvir Singh
30Dayanand Medical College and Hospital, Ludhiana, Ludhiana, India
Rajasekar Thirugnanam
17Kovai Medical Center and Hospital, Coimbatore, India
Vasu Babu Goli
31Renova Century Hospital, Hyderabad, India
Vikram Mathews
Esha Kaul
23Max Super Specialty Hospital, Delhi, India
Krishna Reddy Golamari
34Manipal Hospital, Vijayawada, India
Kannan Subramanian
35Sahyadri Speciality Hospital Deccan Gymkhana, Pune, India
Lingaraj Nayak
2Tata Memorial Centre, Department of Medical Oncology, Mumbai, India
Alok Shetty
32Tata Memorial Centre, Mumbai, India
Aditya Murali
36Apollo Hospitals, Bangalore, India
Punit Jain
20Apollo Hospital, Mumbai, India
Rajat Bhattacharyya
12Apollo hospital, Kolkata, India
Rakesh Boya
38Apollo Cancer Centres, Vizag, India
Ram Abhinav
17Kovai Medical Center and Hospital, Coimbatore, India
Velu Nair
1Apollo Hospital International Limited, Gandhinagar, Clinical Hematology and Bone Marrow Transplant and cellular Therapy, Gandhinagar, India
Hari Menon
40St. John's Medical College and Hospital, Bangalore, India
Monisha Harimadhavan
6Amrita Institute of Medical Sciences and Research Center, Kochi, India
Mohammed Sadique Ansari
1Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Nishant Tiwari
1Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Shamil Darbar
1Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Supriya Chawkekar
1Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Sushmita Sahay
1Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Manivasagam Sundharam
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Ashish Saroha
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Moumita Basu
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Anjali Jaiswal
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Yuktam Yadav
1Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Sakshi Soni
1Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Jayshree Thorat
1Immunoadoptive Cell Therapy Private Limited (ImmunoACT), Mumbai, India
Shalini Purwar
Nirali Shah
32National Cancer Institute, Pediatric Oncology Branch, Bethesda, United States
Terry Fry
1University of Colorado School of Medicine, Aurora, United States
Nitin Jain
Manju Sengar
32Tata Memorial Centre, Mumbai, India
Rahul Purwar
3Indian Institute of Technology Bombay (IIT Bombay), Mumbai, India