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.
Year: 2025
Type: conference-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.
Source: Blood
Authors: Hasmukh Jain, Atharva Karulkar, Devanshi Kalra, Smrithi Ravikumar, Anand Vaibhaw, Shreshtha Shah, Afrin Firfiray, Juber Pendhari, Sameer Melinkeri, Rahul Bhargava, Neeraj Siddarthan, Dr Dinesh Bhurani, Jayachandran P.K., Esha Kaul, Prashant Mehta, Hari Menon, Bhausaheb Bagal, Kunal Goyal, Prakash Shekhawat, Pavan Kumar Boyella, Rakesh Boya, Ram Abhinav, Rayaz Ahmed, Anil Aribandi, Ashwin V Nair, Chandran Nair, Harish Palaparthi, Lingaraj Nayak, Pawan Singh, Priyanshi Pachauri, Rajat Bhattacharya, Rajiv Kumar, Ranjit Sahoo, Sharat Damodar, Vikram Mathews, Vasu Babu Goli, Abhishek Charan, Ajay Gupta, Amul Kapoor, Anupam Chakrapani, Ashish Bakshi, Bijay Prabhakaran Nair, Bilal Kazi, Debranjani Chattopadhyay, Ganesh S. Jaishetwar, Kaushal Kalra, Kishore Kumar, Lekshmon K.S, Madhav Danthala, Mallikarjun Kalashetty, Narendra Anukonda, Naveen Gupta, Nivedita Dhingra, Padmaja Lokireddy, Prasad Narayanan, Parathan Karunakaran, Prasanth Ganesan, Punit Jain, Priyanka Samal, Ramaswamy N.V., Rajan Kapoor, Shyam Aggarwal, Roy J Palatty, Sainath Bhethanabhotla, Sachin Almel, Santhosh Devadas, Sivakumaran Janakiraman, Sudeep V, Sreeraj Vasudevan, Sameer Tulpule, Suraj Chiraniya, Vijay Patil, Sumita Chaudhry, T Raja, Sunu Cyriac, Shishir Seth, Chezhian Subash, Varun Rajan, Alok Shetty, Vishwanath Sathyanarayanan, Mohammed Sadique Ansari, Nishant Tiwari, Shamil Darbar, Supriya Chawkekar, Sushmita Sahay, Manivasagam Sundharam, Ashish Saroha, Moumita Basu, Anjali Jaiswal, Yuktam Yadav, Sakshi Soni, Jayashree Thorat, Shalini Purwar, Nirali Shah, Terry Fry, Nitin Jain, Sattva Neelapu, Manju Sengar, Rahul Purwar
Institutions: Homi Bhabha National Institute, Tata Memorial Hospital, Deenanath Mangeshkar Hospital and Research Center, Amrita Institute of Medical Sciences and Research Centre, Rajiv Gandhi Cancer Institute and Research Centre, Cancer Institute (WIA), Max Super Speciality Hospital, St.John's Medical College Hospital, Kokilaben Dhirubhai Ambani Hospital, Bhagwan Mahaveer Cancer Hospital and Research Centre, Basavatarakam Indo American Cancer Hospital and Research Institute, Kovai Medical Center and Hospital, Kerala Institute of Medical Sciences, Malabar Cancer Centre, Krishna Institute of Medical Sciences, Fortis Hospital, Army Hospital Research and Referral, All India Institute of Medical Sciences, Mazumdar Shaw Medical Centre, Christian Medical College, Vellore, Safdarjang Hospital, Madras Institute of Orthopaedics and Traumatology, Yashoda Hospital, Manipal Hospital, Star Hospitals, Apollo Hospitals, Jawaharlal Institute of Post Graduate Medical Education and Research, Institute of Medical Sciences and Sum Hospital, Sir Ganga Ram Hospital, Rajagiri Hospital, M S Ramaiah Memorial Hospital, Amala Institute of Medical Sciences, P. D. Hinduja Hospital and Medical Research Centre, Apollo Hospitals, Medical Trust Hospital, National Institutes of Health, National Cancer Institute, Center for Cancer Research, University of Colorado Hospital, The University of Texas MD Anderson Cancer Center, Indian Institute of Technology Bombay
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4417018859
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