Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry
Background Tisagenlecleucel, a CD19 chimeric antigen receptor T-cell therapy, is approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after ≥2 lines of therapy. When used in real-world settings, tisagenlecleucel has shown s...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-02-01
|
| Series: | Journal for ImmunoTherapy of Cancer |
| Online Access: | https://jitc.bmj.com/content/13/2/e009890.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1823861234305335296 |
|---|---|
| author | Frederick L Locke Grant Schofield Marcelo Pasquini Matthew J Frigault Cameron J Turtle Stephen Lim Brian Hill Samantha Jaglowski Caron A Jacobson Gunjan Shah Daniel J Landsburg Michael Heim Stephen Ronan Foley Ron Ram Peter A Riedell Leslie L Popplewell Ranjan Tiwari Marta Majdan Aisha Masood |
| author_facet | Frederick L Locke Grant Schofield Marcelo Pasquini Matthew J Frigault Cameron J Turtle Stephen Lim Brian Hill Samantha Jaglowski Caron A Jacobson Gunjan Shah Daniel J Landsburg Michael Heim Stephen Ronan Foley Ron Ram Peter A Riedell Leslie L Popplewell Ranjan Tiwari Marta Majdan Aisha Masood |
| author_sort | Frederick L Locke |
| collection | DOAJ |
| description | Background Tisagenlecleucel, a CD19 chimeric antigen receptor T-cell therapy, is approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after ≥2 lines of therapy. When used in real-world settings, tisagenlecleucel has shown similar efficacy and improved safety compared with previous clinical trials. However, long-term data on real-world outcomes are lacking.Methods Clinical data from a cohort of patients treated with tisagenlecleucel in a real-world setting were captured in the Center for International Blood and Marrow Transplant Research registry. The main clinical outcomes analysed included response rate, duration of response, survival, adverse events and clinicopathologic and treatment characteristics that may affect those outcomes.Results As of May 2022, 1159 patients with R/R DLBCL/HGBCL received tisagenlecleucel. The overall response rate was 59.5%, and the complete response rate was 44.5%. With a median follow-up of 23.2 months in the efficacy set (n=968), the 24 month rates of progression-free survival, ongoing response and overall survival were 28.4%, 52.6% and 43.6%, respectively. Grade ≥3 cytokine release syndrome and neurotoxicity were reported in 6% and 7.4% of patients, respectively. Patients with DLBCL (vs HGBCL), complete response before infusion, prior autologous or allogeneic haematopoietic stem cell transplant and lactate dehydrogenase (LDH) within normal limits experienced more favourable efficacy outcomes, and those with Eastern Cooperative Oncology Group performance status of ≥2, ≥3 prior lines of therapy, elevated LDH and fludarabine-based lymphodepleting chemotherapy experienced less favourable safety outcomes.Conclusions This real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes.Tisagenlecleucel, a CD19 chimeric antigen receptor T-cell therapy, is approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after ≥2 lines of therapy. When used in real-world settings, tisagenlecleucel has shown similar efficacy and improved safety compared with previous clinical trials. However, long-term data on real-world outcomes are lacking.Clinical data from a cohort of patients treated with tisagenlecleucel in a real-world setting were captured in the Center for International Blood and Marrow Transplant Research registry. The main clinical outcomes analysed included response rate, duration of response, survival, adverse events, and clinicopathologic and treatment characteristics that may affect those outcomes.As of May 2022, 1159 patients with R/R DLBCL/HGBCL received tisagenlecleucel. The overall response rate was 59.5%, and the complete response rate was 44.5%. With a median follow-up of 23.2 months in the efficacy set (n=968), the 24 month rates of progression-free survival, ongoing response, and overall survival were 28.4%, 52.6%, and 43.6%, respectively. Grade ≥3 cytokine release syndrome and neurotoxicity were reported in 6% and 7.4% of patients, respectively. Patients with DLBCL (vs HGBCL), complete response before infusion, prior autologous or allogeneic haematopoietic stem cell transplant, and lactate dehydrogenase (LDH) within normal limits experienced more favourable efficacy outcomes, and those with Eastern Cooperative Oncology Group performance status ≥2, ≥3 prior lines of therapy, elevated LDH, and fludarabine-based lymphodepleting chemotherapy experienced less favourable safety outcomes.In conclusion, this real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes. |
| format | Article |
| id | doaj-art-15892e954fc642faa2e68747c56153ae |
| institution | Kabale University |
| issn | 2051-1426 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj-art-15892e954fc642faa2e68747c56153ae2025-02-10T03:30:09ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262025-02-0113210.1136/jitc-2024-009890Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registryFrederick L Locke0Grant Schofield1Marcelo Pasquini2Matthew J Frigault3Cameron J Turtle4Stephen Lim5Brian Hill6Samantha Jaglowski7Caron A Jacobson8Gunjan Shah9Daniel J Landsburg10Michael Heim11Stephen Ronan Foley12Ron Ram13Peter A Riedell14Leslie L Popplewell15Ranjan Tiwari16Marta Majdan17Aisha Masood18Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, Florida, USADepartment of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York, USACenter for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USADepartment of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USAFaculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, AustraliaNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USADepartment of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio, USADepartment of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USADepartment of Medical Oncology, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts, USAAdult Bone Marrow Transplant Service and Cellular Therapy Services, Department of Medcicine, Memorial Sloan Kettering Cancer Center, New York, New York, USADepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USACenter for International Blood and Marrow Transplant Research, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USAJuravinski Hospital and Cancer Centre, McMaster University, Hamilton, Ontario, CanadaBone Marrow Transplant Unit, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, IsraelThe David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago, Illinois, USADepartment of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, California, USANovartis Healthcare Pvt Ltd, Hyderabad, IndiaNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USANovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USABackground Tisagenlecleucel, a CD19 chimeric antigen receptor T-cell therapy, is approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after ≥2 lines of therapy. When used in real-world settings, tisagenlecleucel has shown similar efficacy and improved safety compared with previous clinical trials. However, long-term data on real-world outcomes are lacking.Methods Clinical data from a cohort of patients treated with tisagenlecleucel in a real-world setting were captured in the Center for International Blood and Marrow Transplant Research registry. The main clinical outcomes analysed included response rate, duration of response, survival, adverse events and clinicopathologic and treatment characteristics that may affect those outcomes.Results As of May 2022, 1159 patients with R/R DLBCL/HGBCL received tisagenlecleucel. The overall response rate was 59.5%, and the complete response rate was 44.5%. With a median follow-up of 23.2 months in the efficacy set (n=968), the 24 month rates of progression-free survival, ongoing response and overall survival were 28.4%, 52.6% and 43.6%, respectively. Grade ≥3 cytokine release syndrome and neurotoxicity were reported in 6% and 7.4% of patients, respectively. Patients with DLBCL (vs HGBCL), complete response before infusion, prior autologous or allogeneic haematopoietic stem cell transplant and lactate dehydrogenase (LDH) within normal limits experienced more favourable efficacy outcomes, and those with Eastern Cooperative Oncology Group performance status of ≥2, ≥3 prior lines of therapy, elevated LDH and fludarabine-based lymphodepleting chemotherapy experienced less favourable safety outcomes.Conclusions This real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes.Tisagenlecleucel, a CD19 chimeric antigen receptor T-cell therapy, is approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after ≥2 lines of therapy. When used in real-world settings, tisagenlecleucel has shown similar efficacy and improved safety compared with previous clinical trials. However, long-term data on real-world outcomes are lacking.Clinical data from a cohort of patients treated with tisagenlecleucel in a real-world setting were captured in the Center for International Blood and Marrow Transplant Research registry. The main clinical outcomes analysed included response rate, duration of response, survival, adverse events, and clinicopathologic and treatment characteristics that may affect those outcomes.As of May 2022, 1159 patients with R/R DLBCL/HGBCL received tisagenlecleucel. The overall response rate was 59.5%, and the complete response rate was 44.5%. With a median follow-up of 23.2 months in the efficacy set (n=968), the 24 month rates of progression-free survival, ongoing response, and overall survival were 28.4%, 52.6%, and 43.6%, respectively. Grade ≥3 cytokine release syndrome and neurotoxicity were reported in 6% and 7.4% of patients, respectively. Patients with DLBCL (vs HGBCL), complete response before infusion, prior autologous or allogeneic haematopoietic stem cell transplant, and lactate dehydrogenase (LDH) within normal limits experienced more favourable efficacy outcomes, and those with Eastern Cooperative Oncology Group performance status ≥2, ≥3 prior lines of therapy, elevated LDH, and fludarabine-based lymphodepleting chemotherapy experienced less favourable safety outcomes.In conclusion, this real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes.https://jitc.bmj.com/content/13/2/e009890.full |
| spellingShingle | Frederick L Locke Grant Schofield Marcelo Pasquini Matthew J Frigault Cameron J Turtle Stephen Lim Brian Hill Samantha Jaglowski Caron A Jacobson Gunjan Shah Daniel J Landsburg Michael Heim Stephen Ronan Foley Ron Ram Peter A Riedell Leslie L Popplewell Ranjan Tiwari Marta Majdan Aisha Masood Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry Journal for ImmunoTherapy of Cancer |
| title | Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry |
| title_full | Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry |
| title_fullStr | Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry |
| title_full_unstemmed | Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry |
| title_short | Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry |
| title_sort | real world outcomes with tisagenlecleucel in aggressive b cell lymphoma subgroup analyses from the cibmtr registry |
| url | https://jitc.bmj.com/content/13/2/e009890.full |
| work_keys_str_mv | AT frederickllocke realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT grantschofield realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT marcelopasquini realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT matthewjfrigault realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT cameronjturtle realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT stephenlim realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT brianhill realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT samanthajaglowski realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT caronajacobson realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT gunjanshah realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT danieljlandsburg realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT michaelheim realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT stephenronanfoley realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT ronram realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT peterariedell realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT leslielpopplewell realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT ranjantiwari realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT martamajdan realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry AT aishamasood realworldoutcomeswithtisagenlecleucelinaggressivebcelllymphomasubgroupanalysesfromthecibmtrregistry |