Characterising the Latency Period of Secondary Primary Malignancy and Lymphoma Onset Following Tisagenlecleucel (CAR-T Cell Therapy): A Real-World Data Analysis
Author(s)
aliah aldahash, MSc1, Roaa M. Alamri, MSc2.
1Saudi Food and Drug Authority, Riyadh, Saudi Arabia, 2Saudi Food and Drug Authority, riyadh, Saudi Arabia.
1Saudi Food and Drug Authority, Riyadh, Saudi Arabia, 2Saudi Food and Drug Authority, riyadh, Saudi Arabia.
OBJECTIVES: To characterise the latency period of diagnosis of second primary malignancy and lymphoma following Tisagenlecleucel, using the WHO's Vigibase database, and to identify its association factor of information component (IC).
METHODS: A retrospective analysis was conducted on all reported cases of Tisagenlecleucel and Second Primary Malignancy and Lymphoma retrieved from the World Health Organization (WHO) database via the signal detection tool Vigibase and the National Pharmacovigilance Center (NPC) database from the first reported case in 2018 up to 6 April 2025.
RESULTS: Local cases: No local cases were identified in the National Pharmacovigilance Center (NPC) database. Global Cases: the search in the World Health Organization (WHO) database “Vigibase” resulted in 98 Individualized Case Safety Reports (ICSRs). The mean age was 50 years (range 7- 78 years). Among cases, 79 patients (79.6%) developed a second primary malignancy, and 19 patients (19.4%) developed Lymphoma. Disproportionality analysis of the information component resulted in a value of 5.5, with all ICSRs classified as serious and 43.88% classified as fatal (n=43); the mean time-to-onset between the administration of Tisagenlecleucel and the diagnosis of was 7.3 months (range 1 -24 months).
CONCLUSIONS: The distinct result with an IC value of 5.5 suggests a potential Tisagenlecleucel-related risk of second primary malignancy and lymphoma, demanding close post-marketing surveillance starting as early as one month after infusion. Further studies utilising real-world data are crucial to identifying predictive factors for secondary primary malignancy and lymphoma in survivors treated with Tisagenlecleucel.
METHODS: A retrospective analysis was conducted on all reported cases of Tisagenlecleucel and Second Primary Malignancy and Lymphoma retrieved from the World Health Organization (WHO) database via the signal detection tool Vigibase and the National Pharmacovigilance Center (NPC) database from the first reported case in 2018 up to 6 April 2025.
RESULTS: Local cases: No local cases were identified in the National Pharmacovigilance Center (NPC) database. Global Cases: the search in the World Health Organization (WHO) database “Vigibase” resulted in 98 Individualized Case Safety Reports (ICSRs). The mean age was 50 years (range 7- 78 years). Among cases, 79 patients (79.6%) developed a second primary malignancy, and 19 patients (19.4%) developed Lymphoma. Disproportionality analysis of the information component resulted in a value of 5.5, with all ICSRs classified as serious and 43.88% classified as fatal (n=43); the mean time-to-onset between the administration of Tisagenlecleucel and the diagnosis of was 7.3 months (range 1 -24 months).
CONCLUSIONS: The distinct result with an IC value of 5.5 suggests a potential Tisagenlecleucel-related risk of second primary malignancy and lymphoma, demanding close post-marketing surveillance starting as early as one month after infusion. Further studies utilising real-world data are crucial to identifying predictive factors for secondary primary malignancy and lymphoma in survivors treated with Tisagenlecleucel.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD61
Topic Subcategory
Health & Insurance Records Systems
Disease
STA: Genetic, Regenerative & Curative Therapies