Tali-cel is a safe and effective therapy in patients with Relapsed/Refractory B-cell non-Hodgkin lymphoma that allows equitable access- a real-world experience from India.
Abstract
Abstract 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.
Article Details
Authors (99)
Hasmukh Jain
11Hematolymphoid Unit, Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Atharva Karulkar
2Immunoadoptive Cell Therapy Private Limited (ImmunoACT), 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
Sameer Melinkeri
6Deenanath Mangeshkar Hospital, Pune, India
Rahul Bhargava
25Fortis Hospital, Gurugram, India
Neeraj Siddarthan
3Amrita Hospital, Kochi, Kochi, India
Dr Dinesh Bhurani
2Rajiv Gandhi Cancer Institute and Research Centre, Pathology, Delhi, India
Jayachandran P.K.
21Adyar (WIA) Cancer Institute, Chennai, India
Esha Kaul
23Max Super Specialty Hospital, Delhi, India
Prashant Mehta
8Amrita Hospital, Faridabad, Faridabad, India
Hari Menon
40St. John's Medical College and Hospital, Bangalore, India
Bhausaheb Bagal
2Tata Memorial Centre, Department of Medical Oncology, Mumbai, India
Kunal Goyal
11Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Navi Mumbai, India
Prakash Shekhawat
14Bhagwan Mahavir Cancer Hospital and Research Centre, Jaipur, India
Pavan Kumar Boyella
9Basavatarakam Indo-American Cancer Hospital & Research Institute, Hyderabad, India
Rakesh Boya
38Apollo Cancer Centres, Vizag, India
Ram Abhinav
17Kovai Medical Center and Hospital, Coimbatore, India
Rayaz Ahmed
3Max Super Specialty Hospital Saket, Delhi, India
Anil Aribandi
19Sindhu Hospital, Hyderabad, India
Ashwin V Nair
18KIMS Health Cancer Centre, Trivandrum, India
Chandran Nair
5Malabar Cancer Centre, Thalassery, India
Harish Palaparthi
20KIMS Health Cancer Centre, Secunderabad, India
Lingaraj Nayak
2Tata Memorial Centre, Department of Medical Oncology, Mumbai, India
Pawan Singh
21Yatharth Hospital, Noida, India
Priyanshi Pachauri
22Fortis Hospital, Noida, India
Rajat Bhattacharya
23Apollo Hospitals, Kolkata, India
Rajiv Kumar
Ranjit Sahoo
25All India Institute of Medical Sciences, Delhi, India
Sharat Damodar
2Mazumdar Shaw Medical Centre, Narayana Health City, Bengaluru, India
Vikram Mathews
Vasu Babu Goli
31Renova Century Hospital, Hyderabad, India
Abhishek Charan
29Hcg cancer centre, Shipra Path, Shanthi Nagar, Mansarovar, Jaipur, India
Ajay Gupta
Amul Kapoor
24Army Hospital Research and Referral, Delhi, India
Anupam Chakrapani
12Apollo hospital, Kolkata, India
Ashish Bakshi
32Dr. L.H Hiranandani Hospital, Mumbai, India
Bijay Prabhakaran Nair
18KIMS Health Cancer Centre, Trivandrum, India
Bilal Kazi
33SunAct Cancer Institute, Thane, India
Debranjani Chattopadhyay
34TMC, Kolkata, India
Ganesh S. Jaishetwar
35Yashoda Hospital Hi Tech City, Hyderabad, India
Kaushal Kalra
36VMMC & Safdarjung Hospital, Delhi, India
Kishore Kumar
3MIOT International, Chennai, India
Lekshmon K.S
38KIMS Health Cancer Centre, Thiruvananthapuram, India
Madhav Danthala
39Yashoda Hospital, Somajiguda, India
Mallikarjun Kalashetty
40Manipal Hospitals, Bangalore, India
Narendra Anukonda
41Star hospital, Hyderabad, India
Naveen Gupta
42MGMC, Jaipur, India
Nivedita Dhingra
43Max Super Speciality Hospital, Patparganj, India
Padmaja Lokireddy
10Apollo Hospitals, Hyderabad, India
Prasad Narayanan
45Cytecare, Banglore, India
Parathan Karunakaran
5Cancer Institute (WIA) Adyar, Chennai, India
Prasanth Ganesan
Department of Medicine (R.A.A., S.B., K.A.B., X.L., P.G., A.C.P., E.A.A., P.J.W., M.V.P., S.M.N., A.J.R.), Stanford University, CA.
Punit Jain
20Apollo Hospital, Mumbai, India
Priyanka Samal
Ramaswamy N.V.
50Lisie Hospital, Kochi, India
Rajan Kapoor
1Army Hospital (Research & Referral), Delhi, India
Shyam Aggarwal
51Sir Ganga Ram Hospital, Delhi, India
Roy J Palatty
52Rajagiri Hospital, Kochi, India
Sainath Bhethanabhotla
53Star Hospitals, Nanakramguda, Hyderabad, India
Sachin Almel
54Star Hospital, Hyderabad, India
Santhosh Devadas
6M.S Ramaih Medical College, Medical Oncology, Bengaluru, India
Sivakumaran Janakiraman
56Kovai Medical Centre and Hospitals, Coimbatore, India
Sudeep V
57Aster MIMS hospital, Calicut, India
Sreeraj Vasudevan
8Amala Institute of Medical Sciences, Department of Clinical Hematology, Thrissur, India
Sameer Tulpule
26Kokilaben Dhirubhai Ambani Hospital, Mumbai, India
Suraj Chiraniya
29Dr. LH Hiranandani Hospital Powai, Mumbai, India
Vijay Patil
61P.D. Hinduja Hospital, Mumbai, India
Sumita Chaudhry
36VMMC & Safdarjung Hospital, Delhi, India
T Raja
62Apollo Hospitals, Chennai, India
Sunu Cyriac
63Amala hospital, Thrissur, India
Shishir Seth
64Apollo Hospital, Indraprastha, India
Chezhian Subash
65MIOT Hospital, Chennai, India
Varun Rajan
22Medical Trust Hospital, Ernakulam, India
Alok Shetty
32Tata Memorial Centre, Mumbai, India
Vishwanath Sathyanarayanan
67Apollo Hospitals, Banglore, 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
Jayashree Thorat
2Immunoadoptive 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
Sattva Neelapu
4The University of Texas MD Anderson Cancer Center, Department of Lymphoma and Myeloma, Houston, United States
Manju Sengar
32Tata Memorial Centre, Mumbai, India
Rahul Purwar
3Indian Institute of Technology Bombay (IIT Bombay), Mumbai, India