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Chimeric Antigen Receptor T-Cell Therapy in the Veterans Affairs Network: the Tennessee Valley Healthcare System Experience
BACKGROUND
Chimeric antigen receptor T-cell (CAR-T) therapy is a novel treatment for hematologic malignancies, with 6 FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is currently the only VA facility accredited to administer these agents and we are reporting the TVHS experience thus far.
METHODS
TVHS became an authorized treatment center for CAR-T therapy in September 2019 and performed its first CAR-T infusion in December 2019. This is a retrospective electronic chart review of all CAR-T veterans referred to TVHS from the program’s inception, December 1, 2019 through July 31, 2022 to evaluate at least one year of post infusion data. The primary objective is to evaluate the outcomes of veterans who received CAR-T therapy at TVHS including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
RESULTS
A total of 41 veterans have received CAR-T infusion at TVHS to date. Twenty-nine of these veterans have at least one year post-CAR-T infusion data and are included in this analysis. The majority of veterans were White (72%), male (93%), and were treated for diffuse large B-cell lymphoma (86%). Twenty-eight percent of veterans were under-represented minorities. Average age was 61 years with 62% being 65 years and older and five (17%) veterans being over the age of 74. Day 30 ORR was 90% (45% complete response [CR]). One-year PFS was 55.2% and 1-year OS was 65.5%. Of the 19 veterans who achieved CR by day 100, 79% remain in CR to date. CRS toxicity was observed in 66% of veterans (0% Grade 3 or higher). ICANS was observed in 27.5% of veterans (24% Grade 3 or higher). Only 5 (26%) veterans required transfer to the intensive care unit for additional monitoring.
CONCLUSIONS
CAR-T therapy has become a wellestablished practice at TVHS and is a safe and effective treatment option for veterans with aggressive lymphoid malignancies. Our outcomes are similar to that seen nationally with better access to under-represented minorities in an aging population.
BACKGROUND
Chimeric antigen receptor T-cell (CAR-T) therapy is a novel treatment for hematologic malignancies, with 6 FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is currently the only VA facility accredited to administer these agents and we are reporting the TVHS experience thus far.
METHODS
TVHS became an authorized treatment center for CAR-T therapy in September 2019 and performed its first CAR-T infusion in December 2019. This is a retrospective electronic chart review of all CAR-T veterans referred to TVHS from the program’s inception, December 1, 2019 through July 31, 2022 to evaluate at least one year of post infusion data. The primary objective is to evaluate the outcomes of veterans who received CAR-T therapy at TVHS including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
RESULTS
A total of 41 veterans have received CAR-T infusion at TVHS to date. Twenty-nine of these veterans have at least one year post-CAR-T infusion data and are included in this analysis. The majority of veterans were White (72%), male (93%), and were treated for diffuse large B-cell lymphoma (86%). Twenty-eight percent of veterans were under-represented minorities. Average age was 61 years with 62% being 65 years and older and five (17%) veterans being over the age of 74. Day 30 ORR was 90% (45% complete response [CR]). One-year PFS was 55.2% and 1-year OS was 65.5%. Of the 19 veterans who achieved CR by day 100, 79% remain in CR to date. CRS toxicity was observed in 66% of veterans (0% Grade 3 or higher). ICANS was observed in 27.5% of veterans (24% Grade 3 or higher). Only 5 (26%) veterans required transfer to the intensive care unit for additional monitoring.
CONCLUSIONS
CAR-T therapy has become a wellestablished practice at TVHS and is a safe and effective treatment option for veterans with aggressive lymphoid malignancies. Our outcomes are similar to that seen nationally with better access to under-represented minorities in an aging population.
BACKGROUND
Chimeric antigen receptor T-cell (CAR-T) therapy is a novel treatment for hematologic malignancies, with 6 FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is currently the only VA facility accredited to administer these agents and we are reporting the TVHS experience thus far.
METHODS
TVHS became an authorized treatment center for CAR-T therapy in September 2019 and performed its first CAR-T infusion in December 2019. This is a retrospective electronic chart review of all CAR-T veterans referred to TVHS from the program’s inception, December 1, 2019 through July 31, 2022 to evaluate at least one year of post infusion data. The primary objective is to evaluate the outcomes of veterans who received CAR-T therapy at TVHS including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
RESULTS
A total of 41 veterans have received CAR-T infusion at TVHS to date. Twenty-nine of these veterans have at least one year post-CAR-T infusion data and are included in this analysis. The majority of veterans were White (72%), male (93%), and were treated for diffuse large B-cell lymphoma (86%). Twenty-eight percent of veterans were under-represented minorities. Average age was 61 years with 62% being 65 years and older and five (17%) veterans being over the age of 74. Day 30 ORR was 90% (45% complete response [CR]). One-year PFS was 55.2% and 1-year OS was 65.5%. Of the 19 veterans who achieved CR by day 100, 79% remain in CR to date. CRS toxicity was observed in 66% of veterans (0% Grade 3 or higher). ICANS was observed in 27.5% of veterans (24% Grade 3 or higher). Only 5 (26%) veterans required transfer to the intensive care unit for additional monitoring.
CONCLUSIONS
CAR-T therapy has become a wellestablished practice at TVHS and is a safe and effective treatment option for veterans with aggressive lymphoid malignancies. Our outcomes are similar to that seen nationally with better access to under-represented minorities in an aging population.
Chimeric Antigen Receptor T-cell Therapy in the Veterans Affairs Network: the Tennessee Valley Healthcare System Experience
Purpose/Background
Chimeric antigen receptor T-cell (CART) therapy has emerged as a novel treatment for hematologic malignancies, with six FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is the only VA facility authorized to administer CART therapy. As these therapies are changing the paradigm of treatment, the purpose of this review will report the TVHS experience thus far.
Methods
TVHS began coordination with pharmaceutical manufacturers of CART therapies upon first approval in 2017 and became an authorized treatment center for CART therapy in September 2019 with the first CART infusion performed in December of that year. This is a retrospective electronic chart review of all CART patients referred to TVHS from the program’s inception, December 1, 2019 through June 30, 2021. The primary objective of this analysis will be to evaluate the efficacy outcomes of veterans who received CART therapy at TVHS, including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Results
A total of 28 patients have received CART infusion at TVHS to date. Fifteen of these patients have reached one year post-CART infusion and are included in this analysis. The majority of patients were White (67%) and were treated for diffuse large B-cell lymphoma (87%). All patients were male and ten (67%) were over the age of 65. ORR was 93% (73% achieved complete response [CR]). One-year PFS and OS were both 60%. Of patients who achieved CR by day 100, 89% remain in CR to date. CRS toxicity was observed in 73% of patients (no Grade 3 or higher). ICANS was observed in 26.7% of patients (20% Grade 3 or higher).
Conclusions
CART therapy within the VA has become a well-established practice at TVHS and appears to be a safe and effective therapeutic option for veterans with aggressive lymphoid malignancies.
Purpose/Background
Chimeric antigen receptor T-cell (CART) therapy has emerged as a novel treatment for hematologic malignancies, with six FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is the only VA facility authorized to administer CART therapy. As these therapies are changing the paradigm of treatment, the purpose of this review will report the TVHS experience thus far.
Methods
TVHS began coordination with pharmaceutical manufacturers of CART therapies upon first approval in 2017 and became an authorized treatment center for CART therapy in September 2019 with the first CART infusion performed in December of that year. This is a retrospective electronic chart review of all CART patients referred to TVHS from the program’s inception, December 1, 2019 through June 30, 2021. The primary objective of this analysis will be to evaluate the efficacy outcomes of veterans who received CART therapy at TVHS, including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Results
A total of 28 patients have received CART infusion at TVHS to date. Fifteen of these patients have reached one year post-CART infusion and are included in this analysis. The majority of patients were White (67%) and were treated for diffuse large B-cell lymphoma (87%). All patients were male and ten (67%) were over the age of 65. ORR was 93% (73% achieved complete response [CR]). One-year PFS and OS were both 60%. Of patients who achieved CR by day 100, 89% remain in CR to date. CRS toxicity was observed in 73% of patients (no Grade 3 or higher). ICANS was observed in 26.7% of patients (20% Grade 3 or higher).
Conclusions
CART therapy within the VA has become a well-established practice at TVHS and appears to be a safe and effective therapeutic option for veterans with aggressive lymphoid malignancies.
Purpose/Background
Chimeric antigen receptor T-cell (CART) therapy has emerged as a novel treatment for hematologic malignancies, with six FDA agents approved for commercial use. The Veterans Affairs (VA) Tennessee Valley Healthcare System (TVHS) is the only VA facility authorized to administer CART therapy. As these therapies are changing the paradigm of treatment, the purpose of this review will report the TVHS experience thus far.
Methods
TVHS began coordination with pharmaceutical manufacturers of CART therapies upon first approval in 2017 and became an authorized treatment center for CART therapy in September 2019 with the first CART infusion performed in December of that year. This is a retrospective electronic chart review of all CART patients referred to TVHS from the program’s inception, December 1, 2019 through June 30, 2021. The primary objective of this analysis will be to evaluate the efficacy outcomes of veterans who received CART therapy at TVHS, including overall response rates (ORR), progression free survival (PFS), and overall survival (OS). Secondary objectives include assessment of toxicities, including rates and maximum grades of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Results
A total of 28 patients have received CART infusion at TVHS to date. Fifteen of these patients have reached one year post-CART infusion and are included in this analysis. The majority of patients were White (67%) and were treated for diffuse large B-cell lymphoma (87%). All patients were male and ten (67%) were over the age of 65. ORR was 93% (73% achieved complete response [CR]). One-year PFS and OS were both 60%. Of patients who achieved CR by day 100, 89% remain in CR to date. CRS toxicity was observed in 73% of patients (no Grade 3 or higher). ICANS was observed in 26.7% of patients (20% Grade 3 or higher).
Conclusions
CART therapy within the VA has become a well-established practice at TVHS and appears to be a safe and effective therapeutic option for veterans with aggressive lymphoid malignancies.