Contributions
Abstract: EP737
Type: E-Poster Presentation
Session title: Gene therapy, cellular immunotherapy and vaccination - Clinical
Background
The advent of chimeric antigen receptor (CAR) T-cell therapy has represented one of the most innovative therapeutic advances in oncology in recent years. Impressive clinical responses to CAR T-cell therapy observed in patients with relapsed and refractory B-cell lymphoid malignancies have led to the Food and Drug Administration (FDA) approval of four CAR T-cell therapies in the US since 2017. Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) have now been on the US market for the treatment of patients with LBCL since 2017 and 2018, respectively, hence allowing for assessment of their use in real-world clinical practice.
Aims
This real-world claims-based study aimed to describe characteristics and treatment outcomes of patients with DLBCL treated with the CAR T-cell therapies tisa-cel or axi-cel.
Methods
Patients with at least 1 claim for tisa-cel or axi-cel and a diagnosis code of DLBCL were identified from the Symphony Integrated Dataverse (IDV), a large US claims database containing linked longitudinal prescription, medical, and hospital claims. The IDV contains claims for 280 million active unique patients representing over 73% of specialty prescriptions, 58% of medical claims, and 30% of hospital claims volume in the US. Patient characteristics and treatment patterns were summarized using descriptive statistics.
Results
Among a total of 93 patients with DLBCL identified in this study, 58% (n=54) received axi-cel and 42% (n=39) received tisa-cel. The majority (n=60, 65%) of patients were male, and the median age at time of tisa-cel or axi-cel was 64 years (range, 20-78 years). Commercial insurance was the primary payer at the time of tisa-cel or axi-cel therapy for most patients with DLBCL included in the study (n=77, 83%). Patients with DLBCL treated with tisa-cel or axi-cel were distributed across each of the 4 US census regions. The majority (n=55, 59%) of patients received tisa-cel or axi-cel in the outpatient setting. Tisa-cel or axi-cel was received a median of 12.9 months following patients’ initial diagnosis of DLBCL. Less than half (n=42, 45%) of patients received 2 or more lines of systemic therapy prior to tisa-cel or axi-cel and 17% (n=16) received systemic therapy after tisa-cel or axi-cel during a median follow-up period of 6.3 months.
Conclusion
In the first few years of market availability in the US, the CAR T therapies tisa-cel or axi-cel have been used to treat patients with LBCL outside of the clinical trial setting mostly in the outpatient setting. Findings from this real-world study suggest that patients may be receiving tisa-cel or axi-cel prior to the failure of prior lines of therapy. Despite short follow up, one in 6 patients appear to have relapsed disease based on need for additional systemic therapy. Updated follow-up and outcomes will be presented at time of congress. Further research is warranted to understand real-world clinical outcomes among patients treated with CAR T therapy outside the trial setting.
Keyword(s): B cell lymphoma, CAR-T
Abstract: EP737
Type: E-Poster Presentation
Session title: Gene therapy, cellular immunotherapy and vaccination - Clinical
Background
The advent of chimeric antigen receptor (CAR) T-cell therapy has represented one of the most innovative therapeutic advances in oncology in recent years. Impressive clinical responses to CAR T-cell therapy observed in patients with relapsed and refractory B-cell lymphoid malignancies have led to the Food and Drug Administration (FDA) approval of four CAR T-cell therapies in the US since 2017. Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) have now been on the US market for the treatment of patients with LBCL since 2017 and 2018, respectively, hence allowing for assessment of their use in real-world clinical practice.
Aims
This real-world claims-based study aimed to describe characteristics and treatment outcomes of patients with DLBCL treated with the CAR T-cell therapies tisa-cel or axi-cel.
Methods
Patients with at least 1 claim for tisa-cel or axi-cel and a diagnosis code of DLBCL were identified from the Symphony Integrated Dataverse (IDV), a large US claims database containing linked longitudinal prescription, medical, and hospital claims. The IDV contains claims for 280 million active unique patients representing over 73% of specialty prescriptions, 58% of medical claims, and 30% of hospital claims volume in the US. Patient characteristics and treatment patterns were summarized using descriptive statistics.
Results
Among a total of 93 patients with DLBCL identified in this study, 58% (n=54) received axi-cel and 42% (n=39) received tisa-cel. The majority (n=60, 65%) of patients were male, and the median age at time of tisa-cel or axi-cel was 64 years (range, 20-78 years). Commercial insurance was the primary payer at the time of tisa-cel or axi-cel therapy for most patients with DLBCL included in the study (n=77, 83%). Patients with DLBCL treated with tisa-cel or axi-cel were distributed across each of the 4 US census regions. The majority (n=55, 59%) of patients received tisa-cel or axi-cel in the outpatient setting. Tisa-cel or axi-cel was received a median of 12.9 months following patients’ initial diagnosis of DLBCL. Less than half (n=42, 45%) of patients received 2 or more lines of systemic therapy prior to tisa-cel or axi-cel and 17% (n=16) received systemic therapy after tisa-cel or axi-cel during a median follow-up period of 6.3 months.
Conclusion
In the first few years of market availability in the US, the CAR T therapies tisa-cel or axi-cel have been used to treat patients with LBCL outside of the clinical trial setting mostly in the outpatient setting. Findings from this real-world study suggest that patients may be receiving tisa-cel or axi-cel prior to the failure of prior lines of therapy. Despite short follow up, one in 6 patients appear to have relapsed disease based on need for additional systemic therapy. Updated follow-up and outcomes will be presented at time of congress. Further research is warranted to understand real-world clinical outcomes among patients treated with CAR T therapy outside the trial setting.
Keyword(s): B cell lymphoma, CAR-T