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.
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).
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).
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.