Comparative analysis of adverse event profiles for CAR-T cell therapies and bispecific antibodies in lymphoma.

Abstract

e19019 Background: CAR-T cell therapies and bispecific antibodies (BsAbs) emerged as transformative treatment options for relapsed or refractory lymphomas. Despite their efficacy, these therapies come with distinct safety profiles. CAR-T therapies modify the patient's T-cells to target tumor cells, while BsAbs engage both T-cells and tumor cells. This study compares the adverse event (AE) profiles of CAR-T and BsAb therapies in lymphoma treatment. Methods: A retrospective analysis was conducted using the FAERS database to assess AE reports associated with CAR-T therapies (Breyanzi, Kymriah, Yescarta, and Tecartus) and BsAbs (Epcoritamab, Glofitamab, Odronextamab, Mosunetuzumab, and Plamotamab). AEs were categorized by System Organ Classes (SOCs) using MedDRA terminology, and the frequency of events was calculated for each drug. Results: A total of 114,398 reports were analyzed: Yescarta (44,620), Kymriah (35,135), Tecartus (15,043), Epcoritamab (9,927), Glofitamab (4,373), Breyanzi (2,929), Mosunetuzumab (2,344), Odronextamab (22), and Plamotamab (5). For CAR-T therapies, the most frequently reported AEs were nervous system AEs (15.33%), General AEs (11.23%), and immune system AEs (9.59%). In contrast, BsAbs had higher incidences of AEs related to Infections (11.96%), General AEs (11.80%), and Immune system AEs (8.28%). CAR-T therapies showed an increased incidence of nervous system and psychiatric disorders, while BsAbs were more commonly associated with infection-related AEs. Notably, Immune system disorders were prevalent across both therapeutic modalities. The results are summarized in the table below. Conclusions: This analysis highlights key differences in the safety profiles of CAR-T and BsAb therapies for lymphoma. CAR-T therapies were associated with a higher incidence of neurological and psychiatric AEs, while BsAbs demonstrated a greater risk of infections. These findings may offer valuable guidance for clinicians in therapy selection and underscore the importance of vigilant monitoring, particularly for neurological toxicities in CAR-T treatments and infection-related risks with BsAbs. Further research is recommended to better understand these trends and inform improved management strategies for both therapeutic options. AE* Breyanzi % Epcoritamab % Glofitamab % Kymriah % Mosunetuzumab % Odronextamab % Plamotamab % Tecartus % Yescarta % Nerv 15 5 4 10 9 - - 15 16 Genrl 11 12 17 11 15 64 20 13 12 Immun 10 8 10 7 7 - 40 9 10 Infec 6 12 9 6 10 14 20 6 5 Resp 6 8 8 5 11 5 20 5 4 Blood 6 8 8 10 6 - - 5 6 Inv 4 5 6 13 4 9 - 4 5 Musc 2 2 2 3 2 5 20 2 2 Neopl 3 5 5 8 6 - - 4 3 Vasc 4 4 4 4 3 9 20 4 4 Card 3 3 2 2 3 - - 3 3 Metab 3 3 2 2 2 - - 2 3 Skin 2 2 2 2 4 - - 2 2 Surg 1 1 0 0 1 - - 1 1 * Nerv: Nervous system;Card: Cardiac; Genrl: General disorders; Immun: Immune system; Infec: Infections; Inv: Investigations; Metab: Metabolism; Musc: Musculoskeletal; Neopl: Neoplasms;Resp: Respiratory; Surg: Surgical and medical procedures; Vasc: Vascular.