Key result
Bispecific antibodies linked to ~63% increase in fatal cardiovascular adverse events.
Why the study?
Cardiovascular adverse events associated with bispecific T-cell engaging antibodies had not been systematically investigated across approved agents.
Do bispecific T-cell engaging antibodies increase the reporting of cardiovascular adverse events in patients with hematological malignancies compared to other therapies?
Observational (n=7,647)
Do bispecific T-cell engaging antibodies increase the reporting of cardiovascular adverse events in patients with hematological malignancies compared to other therapies?
Odds Ratio: 1.63 (95% CI 1.47–1.8)
Bispecific antibodies for hematological malignancies are associated with distinct cardiovascular safety signals, including DIC, hypotension, and fatal CVAEs, which vary by agent and often occur independently of cytokine release syndrome.
May warrant cardiovascular monitoring with bispecific antibodies; leaves open causal links and need for prospective validation.
Cardiovascular adverse events (CVAEs) associated with bispecific T-cell engaging antibodies (BsAbs) have not been systematically investigated across approved agents. In this disproportionality analysis of FAERS (December 2014-September 2025), reports listing BsAbs as the primary suspected drug (n = 7647) were compared with all other drugs in the database (N = 7 289 316) and appropriate active comparators. Adjusted reporting odds ratios (aRORs) were estimated using multivariable logistic regression, adjusting for age, sex, cardiovascular comorbidity, disease, and concomitant cardiotoxic medications. Among 7647 BsAb-associated reports (median age: 60 [36-71] years; 44.6% female), 1408 (18.4%) involved a CVAE and 447 (5.8%) were fatal. BsAbs showed increased reporting of DIC (aROR: 4.35 [3.18-5.96]; n = 49), hypotension (1.61 [1.38-1.89]; n = 181), and fatal CVAEs (1.63 [1.47-1.80]; n = 447). MM-directed BsAbs were associated with shock (2.09 [1.65-2.66]) and myocarditis (3.68 [1.49-9.10]). Blinatumomab was associated with DIC (4.41 [3.05-6.37]) and hypotension (1.46 [1.18-1.81]). Teclistamab showed the strongest myocarditis signal (5.95 [2.16-16.43]; n = 4). Mosunetuzumab showed increased reporting of atrial fibrillation (2.25 [1.15-4.38]) and supraventricular tachycardia (2.21 [1.17-4.15]). CVAEs occurred earlier than non-CVAEs (median 7 vs. 15 days; p < 0.001). The majority of hypotension (56.4%) and heart failure (44.2%) reports occurred independently of both CRS and infection. Case fatality proportions for shock (60.1%), DIC (51.0%), and heart failure (48.1%) exceeded those for CRS (24.3%). BsAb-associated cardiovascular signals, particularly DIC, hemodynamic events, and fatal CVAEs, varied by agent and target antigen. These findings support the need for cardiovascular-specific monitoring during therapy.
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Munir et al. (2026) conducted an observational in Hematological malignancies (n=7,647). Bispecific T-cell engaging antibodies (BsAbs) vs. All other drugs in the FAERS database was evaluated on Fatal cardiovascular adverse events (aROR 1.63, 95% CI 1.47-1.80). Bispecific antibodies for hematological malignancies were associated with increased reporting of fatal cardiovascular adverse events (aROR 1.63), disseminated intravascular coagulation (aROR 4.35), and hypotension (aROR 1.61).
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