Non-Relapse Mortality With Bispecific Antibodies in Hematologic Malignancies: A Dual Systematic Review and Pharmacovigilance Analysis.
Sohaib Irfan, Harshit Khosla, Saad Nasir et al.
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In 30 seconds
This systematic review and meta-analysis, supplemented by a pharmacovigilance analysis of FAERS, assessed non-relapse mortality (NRM) and other toxicities with bispecific antibodies in relapsed/refractory hematologic malignancies. It compared commercially available agents used for relapsed/refractory multiple myeloma and non-Hodgkin lymphoma. Teclistamab showed a high toxicity burden across both analyses, including the highest reported ICANS incidences, greater infection rates—particularly grade > 3—and a non-negligible NRM estimate. Findings for severe toxicities generally converged between trial-level and real-world reporting, while results for some other agents differed.
Key findings
- Teclistamab had the highest ICANS incidences and significantly greater infection rates, particularly for grade > 3 infections.
- Teclistamab had a non-negligible NRM estimate in both the systematic review and meta-analysis and FAERS analysis.
- Glofitamab was associated with severe toxicities, including increased reporting odds for NRM and overall mortality.
- Mosunetuzumab had lower pooled estimates and reporting odds; the review also found low pooled incidences of infections and ICANS.
Why it matters
NRM captures deaths unrelated to disease relapse or progression and can reflect the cumulative burden of treatment toxicity. The findings highlight infections and neurotoxicity as relevant safety concerns during bispecific antibody treatment, while differences between trial-level estimates and real-world reporting for some agents reinforce the value of ongoing safety monitoring.
What to keep in mind
The analysis combined literature-based estimates with FAERS pharmacovigilance data; real-world NRM estimates were described as limited, and reporting odds are not equivalent to incidence.