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 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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Journal
Blood
Published
2025-11-03
DOI
https://doi.org/10.1182/blood-2025-6288
Primary Topic
CAR-T cell therapy research
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article
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article

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.

S. Lalitha Rajalakshmi, Chezhian Subash, J. K., Nivedita Dhingra et al.
Blood
CAR-T cell therapy research
article

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.

S. Lalitha Rajalakshmi, Chezhian Subash, J. K., Nivedita Dhingra, Anil Aribandi, Kunal Goyal, Sameer Ramesh Melinkeri, Sachin Almel, Bilal Kazi, Amul Kapoor, Madhav Danthala, Yogesh Yadav, Rajan Kapoor, Atharva Karulkar, Terry J. Fry, Nitin Jain, Afrin Firfiray, Mallikarjun Kalashetty, Vijay Patil, T Raja, Vasu Babu Goli, Binoj C. Nair, Narendra Anukonda, Lingaraj Nayak, Santhosh Kumar Devadas, Chandran K. Nair, Shishir Seth, Vikram Mathews, Esha Kaul, Ganesh S. Jaishetwar, V Sudeep, Raúl V. Durán, Kaushal Kalra, Rahul Purwar, Sainath Bhethanabhotla, Sameer Tulpule, Sunu Cyriac, Moumita Basu, Ashwin V Nair, Smrithi Ravikumar, Nishant Tiwari, Kishore Kumar, Vishwanath Sathyanarayanan, Bhausaheb Bagal, Ajay Gupta, Juber Pendhari, Sreeraj Vasudevan, Sandeep Sahay, Rajiv Kumar, Rajat Bhattacharya, Pawan Singh, Prasanth Ganesan, Sattva Swarup Neelapu, Jayashree Thorat, Dinesh Bhurani, Manju Sengar, Parathan Karunakaran, Rakesh Reddy Boya, Punit Jain, Soumendra Darbar, Ranjit Kumar Sahoo, Padmaja Lokireddy, Roy J Palatty, Rayaz Ahmed, Naveen Gupta, Prashant Mehta, Priyanka Samal, Mohammed Sadique Ansari, Rahul Bhargava, Anupam Chakrapani, Prasad Narayanan, Shyam Aggarwal, Sharat Damodar, Hasmukh Jain, Sakshi Soni, Hari Menon, Abhishek Charan, Anjali Jaiswal, Alok Shetty, Ashish Bakshi, Varun Rajan, Sumita Chaudhry, Pavan Kumar Boyella, Shruti Janakiraman, Debranjani Chattopadhyay, Nirali Shah, Shreshtha Shah, Shalini Purwar, Ashish Saroha, Anand Vaibhaw, Devanshi Kalra, Prakash Shekhawat, Manivasagam Sundharam, Neeraj Siddarthan, Suraj Chiraniya, Ram Abhinav, Priyanshi Pachauri, Supriya Chawkekar, Harish Palaparthi
article en

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.

BloodVol. 146(Supplement 1)
University of Calicut (IN), Amrita Institute of Medical Sciences and Research Centre (IN), University of Colorado Hospital (US), Madras Institute of Orthopaedics and Traumatology (IN), Indraprastha Apollo Hospitals (IN), Safdarjang Hospital (IN), Malabar Cancer Centre (IN), Apollo Hospitals (IN), Government Medical College (IN), The University of Texas MD Anderson Cancer Center (US), Indian Institute of Technology Bombay (IN), SMS Medical College (IN), Christian Medical College, Vellore (IN), Amala Institute of Medical Sciences (IN), Homi Bhabha National Institute (IN), P. D. Hinduja Hospital and Medical Research Centre (IN), Regional Cancer Center, Thiruvananthapuram (IN), Apollo Gleneagles Hospitals (IN), Cancer Institute (WIA) (IN), Kolkata Municipal Corporation (IN), Medical Trust Hospital (IN), Max Super Speciality Hospital (IN), CARE Hospitals (IN), Lourdes Hospital (IN), Dayanand Medical College & Hospital (IN), Paras Hospitals (IN), Rajiv Gandhi Cancer Institute and Research Centre (IN), Regional Centre for Biotechnology (IN), Basavatarakam Indo American Cancer Hospital and Research Institute (IN), Mazumdar Shaw Medical Centre (IN), Kovai Medical Center and Hospital (IN), Bhagwan Mahaveer Cancer Hospital and Research Centre (IN), Sir Ganga Ram Hospital (IN), Tanvir Hospital (IN), Deenanath Mangeshkar Hospital and Research Center (IN), Century Health (US), Cancer Hospital and Research Institute (IN), Fortis Hospital (IN), Yashoda 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), M S Ramaiah Memorial Hospital (IN), Apollo Hospitals (IN), Manipal Hospital (IN), Army Hospital Research and Referral (IN), Sri Sathya Sai Institute of Higher Learning (IN), Jawaharlal Institute of Post Graduate Medical Education and Research (IN), All India Institute of Medical Sciences (IN), Medical College and Hospital, Kolkata (IN), University of Colorado Denver (US)
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